Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-01 @ 11:51 AM
Study NCT ID:
NCT00913458
Status:
COMPLETED
Last Update Posted:
2014-07-17
First Post:
2009-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Screening to Week 117 (Phase 1, 2, and 3 data)', 'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.', 'otherNumAtRisk': 306, 'otherNumAffected': 130, 'seriousNumAtRisk': 306, 'seriousNumAffected': 28}, {'id': 'EG001', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study.\n\nThe subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study.\n\nParticipants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study', 'otherNumAtRisk': 63, 'otherNumAffected': 10, 'seriousNumAtRisk': 63, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe.\n\nMethotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study.\n\nThe subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study.\n\nParticipants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.', 'otherNumAtRisk': 65, 'otherNumAffected': 8, 'seriousNumAtRisk': 65, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.', 'otherNumAtRisk': 65, 'otherNumAffected': 11, 'seriousNumAtRisk': 65, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'E25+MTX (Phase 3)', 'description': 'Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.', 'otherNumAtRisk': 53, 'otherNumAffected': 13, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'MTX (Phase 3)', 'description': 'Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.', 'otherNumAtRisk': 46, 'otherNumAffected': 8, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Placebo (PBO) (Phase 3)', 'description': 'Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.', 'otherNumAtRisk': 32, 'otherNumAffected': 4, 'seriousNumAtRisk': 32, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ear canal stenosis postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anal Fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bacterial pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastritis Erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Infected Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lower Respiratory Tract Infection Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Soft Tissue Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Foot Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Systemic Sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tendon Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pituitary Tumour Benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Uterine Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Loss Of Consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abortion Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Psychiatric Decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Endometrial Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '2.7', 'ciUpperLimit': '12.5', 'pValueComment': 'The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.', 'groupDescription': 'The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a logistic regression model with treatment as the only factor.', 'testedNonInferiority': False}, {'pValue': '0.0085', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.61', 'ciLowerLimit': '1.3', 'ciUpperLimit': '5.3', 'pValueComment': 'The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.', 'groupDescription': 'The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a logistic regression model with treatment as the only factor.', 'testedNonInferiority': False}, {'pValue': '0.0397', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.22', 'ciLowerLimit': '1.0', 'ciUpperLimit': '4.8', 'pValueComment': 'The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.', 'groupDescription': 'The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a logistic regression model with treatment as the only factor.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '76 and 91 weeks', 'description': "Sustained remission was defined as a DAS28 \\<2.6 at the Week 76 and Week 91 visits without requiring a corticosteroid boost between the Week 52 and Week 64 visits, where the requirement for a corticosteroid boost was defined as a value of DAS28 \\>3.2 at either the Week 56 or Week 64 visit.\n\nDAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hour\\]) and patient's global assessment (PGA) of disease activity.\n\nThe participants who met sustained remission in both Week 76 and 91 are presented here.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all participants who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Complete Response (Using Disease Activity Score Based on 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.\n\nEnd of Phase 1', 'statisticalMethod': 'Binomial test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'End of Phase 1', 'description': 'The composite measure of complete response over the last 3 months of Phase 1 was defined as:\n\n1. DAS28 \\<2.6 at the week 39 and 52 visits and,\n2. No radiographic progression during Phase 1, defined as mean change in modified total Sharp score (mTSS) ≤0.5 and,\n3. Health Assessment Questionnaire (HAQ) ≤ 0.5 at the week 39 and week 52 visits', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 and Final on Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.'}], 'classes': [{'title': 'Week 52 (N = 200)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '3.0', 'groupId': 'OG000'}]}]}, {'title': 'Final on Therapy (N = 269)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.1183', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Significance tests were based on paired t-tests using a 2-sided α=0.05.\n\nWeek 52', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0286', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Significance tests were based on paired t-tests using a 2-sided α=0.05.\n\nFinal on therapy', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '52 week and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': 'mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Overall Work Impairment Due to Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.'}], 'classes': [{'title': 'Week 13 (N = 100)', 'categories': [{'measurements': [{'value': '-27.6', 'spread': '27.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (N = 94)', 'categories': [{'measurements': [{'value': '-32.2', 'spread': '28.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 39 (N = 97)', 'categories': [{'measurements': [{'value': '-35.9', 'spread': '27.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (N = 81)', 'categories': [{'measurements': [{'value': '-37.3', 'spread': '30.7', 'groupId': 'OG000'}]}]}, {'title': 'Final on Therapy (N = 124)', 'categories': [{'measurements': [{'value': '-35.5', 'spread': '31.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Significance tests were based on paired t-tests using a 2-sided α=0.05.\n\nWeek 13, 26, 39, 52 and final on therapy', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': 'WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Impairment While Working Due to Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.'}], 'classes': [{'title': 'Week 13 (N = 140)', 'categories': [{'measurements': [{'value': '-27.1', 'spread': '27.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (N = 138)', 'categories': [{'measurements': [{'value': '-31.5', 'spread': '28.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 39 (N = 129)', 'categories': [{'measurements': [{'value': '-35.3', 'spread': '27.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (N = 116)', 'categories': [{'measurements': [{'value': '-36.6', 'spread': '31.5', 'groupId': 'OG000'}]}]}, {'title': 'Final on Therapy (N = 169)', 'categories': [{'measurements': [{'value': '-33.7', 'spread': '30.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Significance tests were based on paired t-tests using a 2-sided α=0.05.\n\nWeek 13, 26, 39, 52 and final on therapy', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': 'WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed Due to Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.'}], 'classes': [{'title': 'Week 13 (N = 116)', 'categories': [{'measurements': [{'value': '-8.9', 'spread': '34.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (N = 110)', 'categories': [{'measurements': [{'value': '-8.8', 'spread': '32.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 39 (N = 110)', 'categories': [{'measurements': [{'value': '-9.0', 'spread': '30.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (N = 93)', 'categories': [{'measurements': [{'value': '-12.9', 'spread': '32.4', 'groupId': 'OG000'}]}]}, {'title': 'Final on Therapy (N = 138)', 'categories': [{'measurements': [{'value': '-10.7', 'spread': '35.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0063', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Significance tests were based on paired t-tests using a 2-sided α=0.05.\n\nWeek 13', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0053', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Significance tests were based on paired t-tests using a 2-sided α=0.05.\n\nWeek 26', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0027', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Significance tests were based on paired t-tests using a 2-sided α=0.05.\n\nWeek 39', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Significance tests were based on paired t-tests using a 2-sided α=0.05.\n\nWeek 52', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0005', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Significance tests were based on paired t-tests using a 2-sided α=0.05.\n\nFinal on therapy', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': 'WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Activity Impairment Due to Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.'}], 'classes': [{'title': 'Week 13 (N = 244)', 'categories': [{'measurements': [{'value': '-30.3', 'spread': '26.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (N = 241)', 'categories': [{'measurements': [{'value': '-34.7', 'spread': '27.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 39 (N = 224)', 'categories': [{'measurements': [{'value': '-39.9', 'spread': '27.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (N = 194)', 'categories': [{'measurements': [{'value': '-41.3', 'spread': '28.6', 'groupId': 'OG000'}]}]}, {'title': 'Final on Therapy (N = 270)', 'categories': [{'measurements': [{'value': '-36.4', 'spread': '29.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Significance tests were based on paired t-tests using a 2-sided α=0.05.\n\nWeek 13, 26, 39, 52 and final on therapy', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': 'WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving American College of Rhematology 20% (ACR 20) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.'}], 'classes': [{'title': 'Week 2 (N = 297)', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (N = 295)', 'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (N = 290)', 'categories': [{'measurements': [{'value': '225', 'groupId': 'OG000'}]}]}, {'title': 'Week 13 (N = 280)', 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (N = 272)', 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}]}]}, {'title': 'Week 39 (N = 256)', 'categories': [{'measurements': [{'value': '235', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (N = 221)', 'categories': [{'measurements': [{'value': '212', 'groupId': 'OG000'}]}]}, {'title': 'Final on Therapy (N = 301)', 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.\n\nWeek 2, 4, 8, 13, 26, 39, 52 and final on therapy', 'statisticalMethod': 'Binomial test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': "ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving American College of Rhematology 50% (ACR 50) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.'}], 'classes': [{'title': 'Week 2 (N = 297)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (N = 295)', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (N = 290)', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}]}]}, {'title': 'Week 13 (N = 280)', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (N = 272)', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}]}]}, {'title': 'Week 39 (N = 256)', 'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (N = 221)', 'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000'}]}]}, {'title': 'Final on Therapy (N = 301)', 'categories': [{'measurements': [{'value': '229', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.\n\nWeek 2, 4, 8, 13, 26, 39, 52 week and final on therapy', 'statisticalMethod': 'Binomial test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': "ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving American College of Rhematology 70% (ACR 70) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.'}], 'classes': [{'title': 'Week 2 (N = 297)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (N = 295)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (N = 290)', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Week 13 (N = 280)', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (N = 272)', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}]}]}, {'title': 'Week 39 (N = 256)', 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (N = 221)', 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}]}]}, {'title': 'Final on Therapy (N = 301)', 'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.\n\nWeek 2, 4, 8, 13, 26, 39, 52 and final on therapy', 'statisticalMethod': 'Binomial test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': "ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving American College of Rhematology 90% (ACR 90) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.'}], 'classes': [{'title': 'Week 2 (N = 297)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (N = 295)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (N = 290)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Week 13 (N = 280)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (N = 272)', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Week 39 (N = 256)', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (N = 221)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}, {'title': 'Final on Therapy (N = 301)', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.\n\nWeek 2, 4, 8, 13, 26, 39, 52 and final on therapy', 'statisticalMethod': 'Binomial test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': "ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Physician's Global Assessment of Disease Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.'}], 'classes': [{'title': 'Week 2 (N = 300)', 'categories': [{'measurements': [{'value': '-21.1', 'spread': '18.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (N = 299)', 'categories': [{'measurements': [{'value': '-29.9', 'spread': '19.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (N = 294)', 'categories': [{'measurements': [{'value': '-34.8', 'spread': '19.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 13 (N = 284)', 'categories': [{'measurements': [{'value': '-38.7', 'spread': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (N = 277)', 'categories': [{'measurements': [{'value': '-42.4', 'spread': '18.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 39 (N = 260)', 'categories': [{'measurements': [{'value': '-46.5', 'spread': '18.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (N = 223)', 'categories': [{'measurements': [{'value': '-49.2', 'spread': '17.2', 'groupId': 'OG000'}]}]}, {'title': 'Final on Therapy (N = 305)', 'categories': [{'measurements': [{'value': '-45.0', 'spread': '19.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Significance tests were based on paired t-tests using a 2-sided α=0.05.\n\nWeek 2, 4, 8, 13, 26, 39, 52 week and final on therapy', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': 'Physician Global Assessment of Disease Activity was measured on a 0 to 100 Visual Analog Scale (VAS), with 0 = no disease activity and 100 = extreme disease activity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Participant's Global Assessment of Disease Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.'}], 'classes': [{'title': 'Week 2 (N = 301)', 'categories': [{'measurements': [{'value': '-23.4', 'spread': '24.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (N = 299)', 'categories': [{'measurements': [{'value': '-27.4', 'spread': '26.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (N = 294)', 'categories': [{'measurements': [{'value': '-31.8', 'spread': '26.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 13 (N = 285)', 'categories': [{'measurements': [{'value': '-34.6', 'spread': '26.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (N = 277)', 'categories': [{'measurements': [{'value': '-40.1', 'spread': '28.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 39 (N = 260)', 'categories': [{'measurements': [{'value': '-44.8', 'spread': '26.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (N = 233)', 'categories': [{'measurements': [{'value': '-48.6', 'spread': '26.2', 'groupId': 'OG000'}]}]}, {'title': 'Final on Therapy (N = 305)', 'categories': [{'measurements': [{'value': '-42.8', 'spread': '28.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Significance tests were based on paired t-tests using a 2-sided α=0.05.\n\nWeek 2, 4, 8, 13, 26, 39, 52 and final on therapy', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': "Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 = extreme disease activity", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DAS44 Score at All Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.'}], 'classes': [{'title': 'Week 2 (N = 297)', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (N = 293)', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (N = 293)', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 13 (N = 282)', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (N = 276)', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 39 (N = 259)', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (N = 221)', 'categories': [{'measurements': [{'value': '-3.4', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Final on Therapy (N = 305)', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Significance tests were based on paired t-tests using a 2-sided α=0.05.\n\nWeek 2, 4, 8, 13, 26, 39, 52 and final on therapy', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': "DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hour\\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 \\<1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44)-Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.'}], 'classes': [{'title': 'Week 2 (N = 297)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (N = 293)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (N = 293)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'Week 13 (N = 282)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (N = 276)', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}]}]}, {'title': 'Week 39 (N = 259)', 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (N = 221)', 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}]}]}, {'title': 'Final on Therapy (N = 305)', 'categories': [{'measurements': [{'value': '211', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.\n\nWeek 2, 4, 8, 13, 26, 39, 52 and final on therapy', 'statisticalMethod': 'Binomial test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': "DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hour\\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 \\<1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.'}], 'classes': [{'title': 'Week 2 (N = 297)', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (N = 293)', 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (N = 293)', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}]}]}, {'title': 'Week 13 (N = 282)', 'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (N = 276)', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000'}]}]}, {'title': 'Week 39 (N = 259)', 'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (N = 221)', 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000'}]}]}, {'title': 'Final on Therapy (N = 305)', 'categories': [{'measurements': [{'value': '249', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.\n\nWeek 2, 4, 8, 13, 26, 39, 52 week and final on therapy', 'statisticalMethod': 'Binomial test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': "DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hour\\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 \\<1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participant who took at least 1 dose of open-label investigational product'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Achieving a Patient Acceptable Symptom State (PASS) at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.'}], 'classes': [{'title': 'Week 2 (N = 297)', 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (N = 292)', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (N = 288)', 'categories': [{'measurements': [{'value': '189', 'groupId': 'OG000'}]}]}, {'title': 'Week 13 (N = 279)', 'categories': [{'measurements': [{'value': '197', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (N = 268)', 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}]}]}, {'title': 'Week 39 (N = 257)', 'categories': [{'measurements': [{'value': '219', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (N = 220)', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}]}]}, {'title': 'Final on Therapy (N = 305)', 'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': "P-value is from McNemar's test for no change from baseline in response rate.\n\nWeek 2, 4, 8, 13, 26, 39, 52 week and final on therapy", 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': 'The PASS is defined as a symptom state that the participants consider acceptable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an American College of Rheumatology 20% (ACR20) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}], 'classes': [{'title': 'Week 52 (N = 63, 63, 65)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 (N = 63, 63, 63)', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}, {'title': 'Week 64 (N = 62, 61, 62)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (N = 60, 55, 46)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Week 91 (N = 57, 50, 38)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Final on Therapy (N = 63, 63, 65)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4075', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.83', 'ciLowerLimit': '0.4', 'ciUpperLimit': '7.6', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.0011', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.88', 'ciLowerLimit': '2.4', 'ciUpperLimit': '33.1', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.0031', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.87', 'ciLowerLimit': '1.7', 'ciUpperLimit': '13.9', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': 'ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and C-Reactive Protein (CRP).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}], 'classes': [{'title': 'Week 52 (N = 63, 63, 65)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 (N = 63, 63, 63)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}, {'title': 'Week 64 (N = 62, 61, 62)', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (N = 60, 55, 46)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'Week 91 (N = 57, 50, 38)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Final on Therapy (N = 63, 63, 65)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5951', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.3', 'ciUpperLimit': '2.0', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.0934', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.19', 'ciLowerLimit': '0.9', 'ciUpperLimit': '5.5', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.0314', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.85', 'ciLowerLimit': '1.1', 'ciUpperLimit': '7.4', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': "ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}], 'classes': [{'title': 'Week 52 (N = 63, 63, 65)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 (N = 63, 63, 63)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Week 64 (N = 62, 61, 62)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (N = 60, 55, 46)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Week 91 (N = 57, 50, 38)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Final on Therapy (N = 63, 63, 65)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.6152', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '0.5', 'ciUpperLimit': '2.8', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.0432', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.36', 'ciLowerLimit': '1.0', 'ciUpperLimit': '5.4', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.1189', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.91', 'ciLowerLimit': '0.8', 'ciUpperLimit': '4.3', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': "ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}], 'classes': [{'title': 'Week 52 (N = 63, 63, 65)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 (N = 63, 63, 63)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Week 64 (N = 62, 61, 62)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (N = 60, 55, 46)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Week 91 (N = 57, 50, 38)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Final on Therapy (N = 63, 63, 65)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0535', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.15', 'ciLowerLimit': '1.0', 'ciUpperLimit': '4.7', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.0064', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.22', 'ciLowerLimit': '1.4', 'ciUpperLimit': '7.5', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.3696', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '0.6', 'ciUpperLimit': '3.6', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '52, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': "ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}], 'classes': [{'title': 'Week 52 (N = 63, 65, 65)', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 (N = 63, 65, 63)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'Week 64 (N = 62, 63, 60)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (N = 60, 57, 46)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Week 91 (N = 57, 52, 38)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Final on Therapy (N = 63, 65, 65)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0788', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.17', 'ciLowerLimit': '0.9', 'ciUpperLimit': '5.2', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.0007', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.57', 'ciLowerLimit': '1.9', 'ciUpperLimit': '11.0', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.0676', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.10', 'ciLowerLimit': '0.9', 'ciUpperLimit': '4.7', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': "DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hour\\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 \\<1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}], 'classes': [{'title': 'Week 52 (N = 63, 65, 65)', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 (N = 63, 65, 63)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}, {'title': 'Week 64 (N = 62, 63, 60)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (N = 60, 57, 46)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Week 91 (N = 57, 52, 38)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'Final on Therapy (N = 63, 65, 65)', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0548', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.56', 'ciLowerLimit': '1.0', 'ciUpperLimit': '59.5', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.0166', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.18', 'ciLowerLimit': '1.6', 'ciUpperLimit': '94.2', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.3619', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.61', 'ciLowerLimit': '0.6', 'ciUpperLimit': '4.5', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': "DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hour\\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 \\<1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Complete Response (Using Disease Activity Score Based on a 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe.Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study.The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 = DAS28 = 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe.All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 = DAS28 = 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.23', 'ciLowerLimit': '1.6', 'ciUpperLimit': '6.7', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.05', 'ciLowerLimit': '4.4', 'ciUpperLimit': '28.0', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.', 'testedNonInferiority': False}, {'pValue': '0.0111', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.42', 'ciLowerLimit': '1.3', 'ciUpperLimit': '8.8', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '52 and 91 weeks', 'description': 'The composite measure of complete response over the last 3 months of Phase 2 was defined as:\n\n1. DAS28 \\<2.6 at the Week 76 and Week 91 visits and\n2. No radiographic progression during Phase 2, defined as mean change from Week 52 in mTSS of ≤0.5.\n3. Participant must achieve HAQ score ≤0.5 at Week 76 and 91 visits. HAQ is self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.A subject had to satisfy all 3 criteria at thevisits to be defined as a responder', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': "Physician's Global Assessment of Disease Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}], 'classes': [{'title': 'Week 52 (N = 63, 65, 65)', 'categories': [{'measurements': [{'value': '5.0', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '8.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 (N = 63, 65, 65)', 'categories': [{'measurements': [{'value': '5.5', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '12.6', 'groupId': 'OG001'}, {'value': '12.2', 'spread': '15.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 64 (N = 62, 63, 62)', 'categories': [{'measurements': [{'value': '6.0', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '16.7', 'groupId': 'OG001'}, {'value': '23.6', 'spread': '26.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (N = 60, 57, 46)', 'categories': [{'measurements': [{'value': '5.5', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '13.6', 'groupId': 'OG001'}, {'value': '14.6', 'spread': '18.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 91 (N = 57, 52, 38)', 'categories': [{'measurements': [{'value': '5.8', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '16.8', 'groupId': 'OG001'}, {'value': '15.9', 'spread': '21.7', 'groupId': 'OG002'}]}]}, {'title': 'Final on Therapy (N = 63, 65, 65)', 'categories': [{'measurements': [{'value': '6.9', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '16.7', 'spread': '21.7', 'groupId': 'OG001'}, {'value': '30.7', 'spread': '28.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0328', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.66', 'ciLowerLimit': '-16.6', 'ciUpperLimit': '-0.7', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.64', 'ciLowerLimit': '-30.1', 'ciUpperLimit': '-13.2', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.', 'testedNonInferiority': False}, {'pValue': '0.0035', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.98', 'ciLowerLimit': '-21.5', 'ciUpperLimit': '-4.5', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': 'Physician Global Assessment of Disease Activity was measured on a 0 to 100 Visual Analog Scale (VAS), with 0 = no disease activity and 100 = extreme disease activity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': "Participant's Global Assessment of Disease Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}], 'classes': [{'title': 'Week 52 (N = 63, 65, 65)', 'categories': [{'measurements': [{'value': '5.8', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '9.3', 'spread': '14.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 (N = 63, 65, 65)', 'categories': [{'measurements': [{'value': '10.3', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '16.3', 'groupId': 'OG001'}, {'value': '17.3', 'spread': '22.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 64 (N = 62, 63, 62)', 'categories': [{'measurements': [{'value': '7.6', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '25.5', 'groupId': 'OG001'}, {'value': '31.0', 'spread': '31.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (N = 60, 56, 46)', 'categories': [{'measurements': [{'value': '8.9', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '17.9', 'groupId': 'OG001'}, {'value': '18.3', 'spread': '18.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 91 (N = 56, 52, 38)', 'categories': [{'measurements': [{'value': '9.6', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '17.5', 'groupId': 'OG001'}, {'value': '18.8', 'spread': '25.7', 'groupId': 'OG002'}]}]}, {'title': 'Final on Therapy (N = 63, 65, 65)', 'categories': [{'measurements': [{'value': '11.1', 'spread': '16.2', 'groupId': 'OG000'}, {'value': '20.7', 'spread': '25.9', 'groupId': 'OG001'}, {'value': '37.1', 'spread': '33.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2473', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.36', 'ciLowerLimit': '-11.8', 'ciUpperLimit': '3.1', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.', 'testedNonInferiority': False}, {'pValue': '0.0016', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.19', 'ciLowerLimit': '-21.3', 'ciUpperLimit': '-5.1', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.', 'testedNonInferiority': False}, {'pValue': '0.0348', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.83', 'ciLowerLimit': '-17.0', 'ciUpperLimit': '-0.6', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': "Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 = extreme disease activity", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': "Participant's Global Assessment of Pain (Visual Analogue Scale) (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}], 'classes': [{'title': 'Week 52 (N = 63, 65, 65)', 'categories': [{'measurements': [{'value': '7.3', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '8.6', 'groupId': 'OG001'}, {'value': '9.9', 'spread': '14.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 (N = 63, 65, 65)', 'categories': [{'measurements': [{'value': '10.9', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '16.9', 'groupId': 'OG001'}, {'value': '18.8', 'spread': '23.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 64 (N = 62, 63, 62)', 'categories': [{'measurements': [{'value': '8.0', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '18.0', 'spread': '25.1', 'groupId': 'OG001'}, {'value': '31.7', 'spread': '31.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (N = 60, 56, 46)', 'categories': [{'measurements': [{'value': '9.8', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '19.2', 'groupId': 'OG001'}, {'value': '17.6', 'spread': '18.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 91 (N = 57, 52, 38)', 'categories': [{'measurements': [{'value': '9.5', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '16.4', 'groupId': 'OG001'}, {'value': '19.7', 'spread': '26.1', 'groupId': 'OG002'}]}]}, {'title': 'Final on Therapy (N = 63, 65, 65)', 'categories': [{'measurements': [{'value': '11.4', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '21.4', 'spread': '24.8', 'groupId': 'OG001'}, {'value': '37.8', 'spread': '33.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1248', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.51', 'ciLowerLimit': '-12.6', 'ciUpperLimit': '1.6', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.', 'testedNonInferiority': False}, {'pValue': '0.0004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.14', 'ciLowerLimit': '-21.8', 'ciUpperLimit': '-6.5', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.', 'testedNonInferiority': False}, {'pValue': '0.0306', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.63', 'ciLowerLimit': '-16.4', 'ciUpperLimit': '-0.8', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': '100-mm line (Visual Analog Scale) marked by the participant to measure their degree of pain over past 2-3 weeks. Range: 0 = no pain to 100 = pain as bad as it could be.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Patient Acceptable Symptom State (PASS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}], 'classes': [{'title': 'Week 52 (N = 61, 65, 64)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}, {'title': 'Week 56 (N = 63, 63, 64)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}, {'title': 'Week 64 (N = 61, 60, 60)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (N = 60, 56, 45)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Week 91 (N = 57, 52, 38)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'Final on Therapy (N = 63, 65, 65)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4717', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '0.5', 'ciUpperLimit': '4.6', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.0551', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.77', 'ciLowerLimit': '1.0', 'ciUpperLimit': '7.8', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.2141', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.84', 'ciLowerLimit': '0.7', 'ciUpperLimit': '4.8', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': 'The PASS is defined as a symptom state that the subjects consider acceptable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': 'Modified Total Sharp Score (mTSS) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '15.1', 'groupId': 'OG001'}, {'value': '8.6', 'spread': '12.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline mTSS at Week 91 and Final on Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}], 'classes': [{'title': 'Week 91 (N = 51, 45, 30)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.21', 'groupId': 'OG002'}]}]}, {'title': 'Final on Therapy (N = 58, 56, 49)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.16', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9652', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.4', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.2168', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.0', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.2131', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.0', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': 'mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WPAI Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}], 'classes': [{'title': 'Week 64 (N = 30, 44, 26)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '2.78', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '2.29', 'groupId': 'OG001'}, {'value': '6.1', 'spread': '3.04', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (N = 28, 33, 18)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.19', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '3.09', 'groupId': 'OG002'}]}]}, {'title': 'Week 91 (N = 29, 32, 14)', 'categories': [{'measurements': [{'value': '4.4', 'spread': '3.78', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '3.63', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '5.79', 'groupId': 'OG002'}]}]}, {'title': 'Final on Therapy (N = 34, 48, 29)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '3.65', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '3.07', 'groupId': 'OG001'}, {'value': '10.2', 'spread': '4.06', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9338', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.44', 'ciLowerLimit': '-10.0', 'ciUpperLimit': '10.9', 'estimateComment': 'Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.', 'groupDescription': 'Change from Week 52 to Week 91. The hyothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7130', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.55', 'ciLowerLimit': '-16.4', 'ciUpperLimit': '11.2', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.6628', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.99', 'ciLowerLimit': '-16.6', 'ciUpperLimit': '10.6', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)', 'description': 'WPAI is a 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named "Percent impairment While Working") and as such range from 0 to 100.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': 'WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '15.5', 'groupId': 'OG001'}, {'value': '14.2', 'spread': '17.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 Weeks', 'description': 'WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}], 'classes': [{'title': 'Week 64 (N = 37, 49, 31)', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '3.57', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '3.16', 'groupId': 'OG001'}, {'value': '18.2', 'spread': '3.96', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (N = 38, 38, 23)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.16', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '2.01', 'groupId': 'OG001'}, {'value': '12.2', 'spread': '2.54', 'groupId': 'OG002'}]}]}, {'title': 'Week 91 (N = 37, 35, 18)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '3.06', 'groupId': 'OG001'}, {'value': '18.4', 'spread': '4.23', 'groupId': 'OG002'}]}]}, {'title': 'Final on Therapy (N = 45, 50, 40)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '3.51', 'groupId': 'OG000'}, {'value': '11.1', 'spread': '3.10', 'groupId': 'OG001'}, {'value': '19.9', 'spread': '3.76', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1303', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.74', 'ciLowerLimit': '-15.5', 'ciUpperLimit': '2.0', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.0024', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.59', 'ciLowerLimit': '-27.1', 'ciUpperLimit': '-6.0', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statisitical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.0621', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.85', 'ciLowerLimit': '-20.2', 'ciUpperLimit': '0.5', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)', 'description': 'WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named "Percent impairment While Working") and as such range from 0 to 100.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': 'WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '15.0', 'groupId': 'OG001'}, {'value': '9.2', 'spread': '12.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}], 'classes': [{'title': 'Week 64 (N = 29, 43, 25)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '4.49', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '3.75', 'groupId': 'OG001'}, {'value': '22.4', 'spread': '2.01', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (N = 27, 30, 18)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '2.18', 'groupId': 'OG001'}, {'value': '16.6', 'spread': '2.95', 'groupId': 'OG002'}]}]}, {'title': 'Week 91 (N = 28, 30, 13)', 'categories': [{'measurements': [{'value': '5.4', 'spread': '3.98', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '3.74', 'groupId': 'OG001'}, {'value': '22.0', 'spread': '5.75', 'groupId': 'OG002'}]}]}, {'title': 'Final on Therapy (N = 34, 48, 28)', 'categories': [{'measurements': [{'value': '4.4', 'spread': '4.32', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '3.60', 'groupId': 'OG001'}, {'value': '25.1', 'spread': '4.84', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4664', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.01', 'ciLowerLimit': '-15.0', 'ciUpperLimit': '6.9', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.0210', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.57', 'ciLowerLimit': '-30.6', 'ciUpperLimit': '-2.6', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.0713', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.56', 'ciLowerLimit': '-26.2', 'ciUpperLimit': '1.1', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)', 'description': 'WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named "Percent impairment While Working") and as such range from 0 to 100.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': 'WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '15.9', 'groupId': 'OG001'}, {'value': '16.8', 'spread': '20.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG001', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'OG002', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}], 'classes': [{'title': 'Week 64 (N = 56, 60, 57)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '3.21', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '3.10', 'groupId': 'OG001'}, {'value': '19.1', 'spread': '3.18', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (N = 57, 55, 41)', 'categories': [{'measurements': [{'value': '2.9', 'spread': '2.94', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '2.96', 'groupId': 'OG001'}, {'value': '13.9', 'spread': '3.35', 'groupId': 'OG002'}]}]}, {'title': 'Week 91 (N = 53, 49, 37)', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '2.87', 'groupId': 'OG001'}, {'value': '17.9', 'spread': '3.20', 'groupId': 'OG002'}]}]}, {'title': 'Final on Therapy (N = 60, 64, 64)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '3.24', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '3.13', 'groupId': 'OG001'}, {'value': '24.2', 'spread': '3.16', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0256', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.11', 'ciLowerLimit': '-17.1', 'ciUpperLimit': '-1.1', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.62', 'ciLowerLimit': '-28.1', 'ciUpperLimit': '-11.1', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.', 'testedNonInferiority': False}, {'pValue': '0.0161', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.51', 'ciLowerLimit': '-19.0', 'ciUpperLimit': '-2.0', 'groupDescription': 'Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.', 'statisticalMethod': 'Longitudinal statistical model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)', 'description': 'WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named "Percent impairment While Working") and as such range from 0 to 100.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.'}, {'id': 'FG001', 'title': 'E25 + MTX (Phase 2)', 'description': 'In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'FG002', 'title': 'MTX + PBO (Phase 2)', 'description': 'In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'FG003', 'title': 'Placebo (PBO) (Phase 2)', 'description': 'In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.\n\nMethotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count \\[DAS28\\] \\<2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.'}, {'id': 'FG004', 'title': 'E25+MTX (Phase 3)', 'description': 'Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.'}, {'id': 'FG005', 'title': 'MTX (Phase 3)', 'description': 'Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.'}, {'id': 'FG006', 'title': 'Placebo (PBO) (Phase 3)', 'description': 'Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.'}], 'periods': [{'title': 'Phase 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '306'}, {'comment': 'This arm is part of Phase 2 study', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'This arm is part of Phase 2 study', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'This arm is part of Phase 2 study', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'This arm is part of Phase 3 study', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'This arm is part of Phase 3 study', 'groupId': 'FG005', 'numSubjects': '0'}, {'comment': 'This arm is part of Phase 3 study', 'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '194 continued to Phase 2 but 1 was randomized in error leaving 193 in the phase 2 analysis.', 'groupId': 'FG000', 'numSubjects': '194'}, {'comment': 'This arm is part of Phase 2 study', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'This arm is part of Phase 2 study', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'This arm is part of Phase 2 study', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'This arm is part of Phase 3 study', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'This arm is part of Phase 3 study', 'groupId': 'FG005', 'numSubjects': '0'}, {'comment': 'This arm is part of Phase 3 study', 'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Non-Responder', 'reasons': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Subject Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Unsatisfactory Response per Investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Phase 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'This arm is part of Phase 1 of the study.', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '65'}, {'groupId': 'FG003', 'numSubjects': '65'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'This arm is part of Phase 1 of the study.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants randomized into Phase 3 of study.', 'groupId': 'FG001', 'numSubjects': '53'}, {'comment': 'Participants randomized into Phase 3 of study.', 'groupId': 'FG002', 'numSubjects': '46'}, {'comment': 'Participants randomized into Phase 3 of study.', 'groupId': 'FG003', 'numSubjects': '32'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '33'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Non-Responder', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Subject Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Unsatisfactory Response per Investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Phase 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'This arm is part of Phase 1 of the study.', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Participants who completed Phase 2 study', 'groupId': 'FG004', 'numSubjects': '53'}, {'comment': 'Participants who completed Phase 2 study', 'groupId': 'FG005', 'numSubjects': '46'}, {'comment': 'Participants who completed Phase 2 study', 'groupId': 'FG006', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'This arm is part of Phase 1 of the study.', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '31'}, {'groupId': 'FG005', 'numSubjects': '28'}, {'groupId': 'FG006', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '22'}, {'groupId': 'FG005', 'numSubjects': '18'}, {'groupId': 'FG006', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Non-Responder', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Unsatisfactory Response per Investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'This report presents the results of open-label 52-week treatment period (Phase 1), 39 week, double blind randomized (Phase 2) and 26 week observational period (Phase 3) part of a 121 week Phase 4 study program. Responders in Phase 1 were randomized to 3 arms (1:1:1 ratio) in Phase 2. Responders in Phase 2, continued to Phase 3 observational period', 'preAssignmentDetails': 'Phase 1 responders, defined as subjects with Disease Activity Score based on 28-joints count (DAS28) ≤ 3.2 at Week 39 and DAS28 \\<2.6 at Week 52, were randomized to Phase 2. The responders of Phase 2 were observed for 26-weeks in Phase 3 study that include 2 to 4 week period of double blind treatment taper of MTX followed by observational period'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ETN 50 QW + MTX (Phase 1)', 'description': 'Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count \\[DAS28\\] ≤3.2 at Week 39 and DAS28 \\<2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.94', 'spread': '13.70', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '213', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '93', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A total of 306 participants were enrolled in the study (Phase 1). Out of the 306 participants, 193 were eligible and were randomized at a ratio of 1:1:1 to Phase 2 study. Of the 193 participants from Phase 2, a total of 131 participants were eligible and were randomized to Phase 3 study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-15', 'studyFirstSubmitDate': '2009-05-26', 'resultsFirstSubmitDate': '2013-06-10', 'studyFirstSubmitQcDate': '2009-06-03', 'lastUpdatePostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-15', 'studyFirstPostDateStruct': {'date': '2009-06-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score', 'timeFrame': '76 and 91 weeks', 'description': "Sustained remission was defined as a DAS28 \\<2.6 at the Week 76 and Week 91 visits without requiring a corticosteroid boost between the Week 52 and Week 64 visits, where the requirement for a corticosteroid boost was defined as a value of DAS28 \\>3.2 at either the Week 56 or Week 64 visit.\n\nDAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hour\\]) and patient's global assessment (PGA) of disease activity.\n\nThe participants who met sustained remission in both Week 76 and 91 are presented here."}], 'secondaryOutcomes': [{'measure': 'Number of Participants Achieving Complete Response (Using Disease Activity Score Based on 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)', 'timeFrame': 'End of Phase 1', 'description': 'The composite measure of complete response over the last 3 months of Phase 1 was defined as:\n\n1. DAS28 \\<2.6 at the week 39 and 52 visits and,\n2. No radiographic progression during Phase 1, defined as mean change in modified total Sharp score (mTSS) ≤0.5 and,\n3. Health Assessment Questionnaire (HAQ) ≤ 0.5 at the week 39 and week 52 visits'}, {'measure': 'Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 and Final on Therapy', 'timeFrame': '52 week and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': 'mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.'}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Overall Work Impairment Due to Problem', 'timeFrame': '13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': 'WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.'}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Impairment While Working Due to Problem', 'timeFrame': '13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': 'WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.'}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed Due to Problem', 'timeFrame': '13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': 'WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.'}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Activity Impairment Due to Problem', 'timeFrame': '13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': 'WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.'}, {'measure': 'Number of Participants Achieving American College of Rhematology 20% (ACR 20) Response', 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': "ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit."}, {'measure': 'Number of Participants Achieving American College of Rhematology 50% (ACR 50) Response', 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': "ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit."}, {'measure': 'Number of Participants Achieving American College of Rhematology 70% (ACR 70) Response', 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': "ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit."}, {'measure': 'Number of Participants Achieving American College of Rhematology 90% (ACR 90) Response', 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': "ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit."}, {'measure': "Change From Baseline in Physician's Global Assessment of Disease Activity", 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': 'Physician Global Assessment of Disease Activity was measured on a 0 to 100 Visual Analog Scale (VAS), with 0 = no disease activity and 100 = extreme disease activity.'}, {'measure': "Change From Baseline in Participant's Global Assessment of Disease Activity", 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': "Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 = extreme disease activity"}, {'measure': 'Change From Baseline in DAS44 Score at All Visits', 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': "DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hour\\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 \\<1.6 = clinical remission, DAS44 ≤2.4 = low disease activity."}, {'measure': 'Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44)-Remission', 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': "DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hour\\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 \\<1.6 = clinical remission, DAS44 ≤2.4 = low disease activity."}, {'measure': 'Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity', 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': "DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hour\\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 \\<1.6 = clinical remission, DAS44 ≤2.4 = low disease activity."}, {'measure': 'Proportion of Subjects Achieving a Patient Acceptable Symptom State (PASS) at Each Visit', 'timeFrame': '2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)', 'description': 'The PASS is defined as a symptom state that the participants consider acceptable.'}, {'measure': 'Number of Participants With an American College of Rheumatology 20% (ACR20) Response', 'timeFrame': '52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': 'ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and C-Reactive Protein (CRP).'}, {'measure': 'Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response', 'timeFrame': '52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': "ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit."}, {'measure': 'Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response', 'timeFrame': '52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': "ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit."}, {'measure': 'Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response', 'timeFrame': '52, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': "ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit."}, {'measure': 'Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) Remission', 'timeFrame': '52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': "DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hour\\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 \\<1.6 = clinical remission, DAS44 ≤2.4 = low disease activity."}, {'measure': 'Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity', 'timeFrame': '52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': "DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hour\\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 \\<1.6 = clinical remission, DAS44 ≤2.4 = low disease activity."}, {'measure': 'Number of Participants Achieving Complete Response (Using Disease Activity Score Based on a 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)', 'timeFrame': '52 and 91 weeks', 'description': 'The composite measure of complete response over the last 3 months of Phase 2 was defined as:\n\n1. DAS28 \\<2.6 at the Week 76 and Week 91 visits and\n2. No radiographic progression during Phase 2, defined as mean change from Week 52 in mTSS of ≤0.5.\n3. Participant must achieve HAQ score ≤0.5 at Week 76 and 91 visits. HAQ is self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.A subject had to satisfy all 3 criteria at thevisits to be defined as a responder'}, {'measure': "Physician's Global Assessment of Disease Activity", 'timeFrame': '52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': 'Physician Global Assessment of Disease Activity was measured on a 0 to 100 Visual Analog Scale (VAS), with 0 = no disease activity and 100 = extreme disease activity.'}, {'measure': "Participant's Global Assessment of Disease Activity", 'timeFrame': '52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': "Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 = extreme disease activity"}, {'measure': "Participant's Global Assessment of Pain (Visual Analogue Scale) (VAS)", 'timeFrame': '52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': '100-mm line (Visual Analog Scale) marked by the participant to measure their degree of pain over past 2-3 weeks. Range: 0 = no pain to 100 = pain as bad as it could be.'}, {'measure': 'Number of Participants Achieving Patient Acceptable Symptom State (PASS)', 'timeFrame': '52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': 'The PASS is defined as a symptom state that the subjects consider acceptable.'}, {'measure': 'Modified Total Sharp Score (mTSS) at Week 52', 'timeFrame': '52 weeks', 'description': 'mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.'}, {'measure': 'Change From Baseline mTSS at Week 91 and Final on Therapy', 'timeFrame': '91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)', 'description': 'mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.'}, {'measure': 'Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem', 'timeFrame': '52 weeks', 'description': 'WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.'}, {'measure': 'Change From Baseline in WPAI Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem', 'timeFrame': '64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)', 'description': 'WPAI is a 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named "Percent impairment While Working") and as such range from 0 to 100.'}, {'measure': 'WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem', 'timeFrame': '52 Weeks', 'description': 'WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.'}, {'measure': 'Change From Baseline in WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem', 'timeFrame': '64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)', 'description': 'WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named "Percent impairment While Working") and as such range from 0 to 100.'}, {'measure': 'WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem', 'timeFrame': '52 weeks', 'description': 'WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.'}, {'measure': 'Change From Baseline in WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem', 'timeFrame': '64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)', 'description': 'WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named "Percent impairment While Working") and as such range from 0 to 100.'}, {'measure': 'WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem', 'timeFrame': '52 weeks', 'description': 'WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named "Percent impairment While Working") and as such range from 0 to 100.'}, {'measure': 'Change From Baseline in WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem', 'timeFrame': '64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)', 'description': 'WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named "Percent impairment While Working") and as such range from 0 to 100.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Active Rheumatoid Arthritis', 'Arthritis, Rheumatoid', 'Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '31277720', 'type': 'DERIVED', 'citation': 'Tanaka Y, Smolen JS, Jones H, Szumski A, Marshall L, Emery P. The effect of deep or sustained remission on maintenance of remission after dose reduction or withdrawal of etanercept in patients with rheumatoid arthritis. Arthritis Res Ther. 2019 Jul 5;21(1):164. doi: 10.1186/s13075-019-1937-4.'}, {'pmid': '28255449', 'type': 'DERIVED', 'citation': 'Fleischmann RM, van der Heijde D, Gardiner PV, Szumski A, Marshall L, Bananis E. DAS28-CRP and DAS28-ESR cut-offs for high disease activity in rheumatoid arthritis are not interchangeable. RMD Open. 2017 Jan 30;3(1):e000382. doi: 10.1136/rmdopen-2016-000382. eCollection 2017.'}, {'pmid': '27486524', 'type': 'DERIVED', 'citation': 'Zhang W, Bansback N, Sun H, Pedersen R, Kotak S, Anis AH. Impact of etanercept tapering on work productivity in patients with early rheumatoid arthritis: results from the PRIZE study. RMD Open. 2016 Jul 7;2(2):e000222. doi: 10.1136/rmdopen-2015-000222. eCollection 2016.'}, {'pmid': '27252426', 'type': 'DERIVED', 'citation': 'Wiland P, Dudler J, Veale D, Tahir H, Pedersen R, Bukowski J, Vlahos B, Williams T, Gaylord S, Kotak S. The Effect of Reduced or Withdrawn Etanercept-methotrexate Therapy on Patient-reported Outcomes in Patients with Early Rheumatoid Arthritis. J Rheumatol. 2016 Jul;43(7):1268-77. doi: 10.3899/jrheum.151179. Epub 2016 Jun 1.'}, {'pmid': '26535135', 'type': 'DERIVED', 'citation': 'Zhang W, Bansback N, Sun H, Pedersen R, Kotak S, Anis AH. Estimating the monetary value of the annual productivity gained in patients with early rheumatoid arthritis receiving etanercept plus methotrexate: interim results from the PRIZE study. RMD Open. 2015 Apr 8;1(1):e000042. doi: 10.1136/rmdopen-2014-000042. eCollection 2015.'}, {'pmid': '25372086', 'type': 'DERIVED', 'citation': 'Emery P, Hammoudeh M, FitzGerald O, Combe B, Martin-Mola E, Buch MH, Krogulec M, Williams T, Gaylord S, Pedersen R, Bukowski J, Vlahos B. Sustained remission with etanercept tapering in early rheumatoid arthritis. N Engl J Med. 2014 Nov 6;371(19):1781-92. doi: 10.1056/NEJMoa1316133.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0881X1-4524&StudyName=Study%20Evaluating%20Etanercept%20plus%20Methotrexate%20in%20Early%20Rheumatoid%20Arthritis', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of early rheumatoid arthritis.\n* Methotrexate (MTX) naive.\n* Active early rheumatoid arthritis at the time of enrollment.\n\nExclusion Criteria:\n\n* Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.\n* Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), within 4 weeks before baseline.\n* Concurrent treatment with more than 1 non-steroidal anti-inflammatory drug (NSAID) at baseline.'}, 'identificationModule': {'nctId': 'NCT00913458', 'briefTitle': 'Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate', 'orgStudyIdInfo': {'id': '0881X1-4524'}, 'secondaryIdInfos': [{'id': 'B1801020'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'etanercept + methotrexate; etanercept + methotrexate', 'interventionNames': ['Drug: etanercept']}], 'interventions': [{'name': 'etanercept', 'type': 'DRUG', 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