Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2026-03-01 @ 12:33 PM
Study NCT ID:
NCT02378506
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2015-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia']}, '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': 'Baseline (Day 1) up to Week 28 (follow-up)', '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 non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Etanercept', 'description': 'Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.', 'otherNumAtRisk': 187, 'otherNumAffected': 85, 'seriousNumAtRisk': 187, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection site urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection site vesicles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hepatic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asymptomatic bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Genitourinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood pressure diastolic abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vitamin D decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Joint instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebrovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Impulsive behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Amenorrhoea', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper-airway cough syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Skin fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Metatarsalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '5.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation. Here, "Number of Participants Analyzed" (N) signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '6.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation. Here, "N" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '1.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to Week 24', 'description': 'Percentage of participants with positive Etanercept neutralizing anti-drug antibodies were summarized.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to Week 28 (Follow-up)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who had taken at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Investigator-Identified Serious Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to Week 28 (Follow-up)', 'description': 'Infection was considered as serious by investigator for any of the following outcomes: death; life-threatening; required initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity or congenital anomaly/birth defect.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who had taken at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to Week 28 (Follow-up)', 'description': 'Injection site reactions included injection site erythema, swelling, pain and warmth.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who had taken at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to Week 28 (Follow-up)', 'description': 'Laboratory abnormalities(national cancer institute toxicity criteria version 4.0),Grade 3:neutrophil (greater than or equal to\\[\\>=\\]0.5,less than\\[\\<\\]1.0 10\\^9/L),lymphocyte (\\<0.5 10\\^9/L),hemoglobin (Hb) (\\<80,\\>=65 gram per liter \\[g/L\\]),platelet(\\<50.0,\\>=25.0 10\\^9/L),white blood count(WBC) (\\<2.0, \\>=1.0 10\\^9/L);alkaline phosphatase (AP),aspartate aminotransferase(AST),alanine aminotransferase(ALT) (greater than\\[\\>\\]5.0\\*upper range \\[UR\\], \\<=20.0\\*UR unit per liter\\[U/L\\]);bilirubin(\\>1.5\\*UR, less than or equal to\\[\\<=\\]3.0\\*UR micromole per liter\\[mcmol/L\\]);creatinine(\\>3.0\\*UR, \\<=6.0\\*UR mcmol/L);albumin (\\<20.0 g/L),urea(\\>3.0\\*UR, \\<=4.0\\*UR g/L);potassium (K)-high,low (\\>6.0,\\<=7.0or\\<3.0,\\>=2.5 mcmol/L); sodium(Na)-high,low(\\>155, \\<=160 or \\<130, \\>=120 mcmol/L)and Grade 4: neutrophil(\\<0.5 10\\^9/L),Hb (\\<65 g/L);platelet (\\<25.0 10\\^9/L); WBC(\\<1.0 10\\^9/L);AP,AST,ALT(\\>20.0\\*UR U/L);bilirubin(\\>3.0\\*UR mcmol/L);creatinine (\\>6.0\\*UR mcmol/L);urea (\\>4.0\\*UR g/L);K-high,low (\\>7.0or\\<2.5 mcmol/L);Na-high, low (\\>160or\\<120 mcmol/L).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who had taken at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.'}], 'classes': [{'title': 'Week 4 (n =186)', 'categories': [{'measurements': [{'value': '55.9', 'groupId': 'OG000', 'lowerLimit': '48.7', 'upperLimit': '62.9'}]}]}, {'title': 'Week 12 (n =179)', 'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000', 'lowerLimit': '69.9', 'upperLimit': '82.3'}]}]}, {'title': 'Week 24 (n =161)', 'categories': [{'measurements': [{'value': '82.0', 'groupId': 'OG000', 'lowerLimit': '75.5', 'upperLimit': '87.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4, 12, 24', 'description': "ACR20 responder: participants with 20 percent (%) improvement in tender and swollen 28-joint counts and 20% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR20 response were reported.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population included all participants who had taken at least 1 dose of study medication. Here, "n" signifies number of participants who were evaluable for specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.'}], 'classes': [{'title': 'Week 4 (n =186)', 'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '21.9'}]}]}, {'title': 'Week 12 (n =179)', 'categories': [{'measurements': [{'value': '36.3', 'groupId': 'OG000', 'lowerLimit': '29.5', 'upperLimit': '43.5'}]}]}, {'title': 'Week 24 (n =161)', 'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000', 'lowerLimit': '50.1', 'upperLimit': '65.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4, 12, 24', 'description': "ACR50 responder: participants with 50% improvement in tender and swollen 28-joint counts and 50% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR50 response were reported.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who had taken at least 1 dose of study medication. Here, "n" signifies number of participants who were evaluable for specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.'}], 'classes': [{'title': 'Week 4 (n =186)', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '6.5'}]}]}, {'title': 'Week 12 (n =179)', 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '19.0'}]}]}, {'title': 'Week 24 (n =161)', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000', 'lowerLimit': '20.3', 'upperLimit': '33.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4, 12, 24', 'description': "ACR70 responder: participants with 70% improvement in tender and swollen 28-joint counts and 70% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR70 response were reported.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who had taken at least 1 dose of study medication. Here, "n" signifies number of participants who were evaluable for specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.'}], 'classes': [{'title': 'Baseline (n =187)', 'categories': [{'measurements': [{'value': '6.2', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 4 (n =186)', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.04', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 12 (n =180)', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 24 (n =162)', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, 12, 24', 'description': "DAS28: measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, erythrocyte sedimentation rate (millimeter per hour \\[mm/hour\\]) and participant's general health visual analog scale assessment (scores: 0 mm \\[very well\\] to 100 mm \\[extremely bad\\], higher scores indicate worse health condition). Total DAS28-4 (ESR) score: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (ESR) less than (\\<) 2.6= remission, \\<3.2= low disease activity, greater than or equal to (\\>=) 3.2 to 5.1= moderate disease activity and \\>5.1= high disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who had taken at least 1 dose of study medication. Here, "n" signifies number of participants who were evaluable for specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.'}], 'classes': [{'title': 'Baseline (n =187)', 'categories': [{'measurements': [{'value': '5.4', 'spread': '0.91', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 4 (n =187)', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.02', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 12 (n =179)', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.09', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 24 (n =162)', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, 12, 24', 'description': "DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from the number of swollen joints and tender joints using the 28 joints count, C-Reactive protein (milligram per liter \\[mg/L\\]) and participant's general health visual analog scale assessment (scores ranging 0 mm \\[very well\\] to 100 mm \\[extremely bad\\], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (CRP) less than (\\<) 2.6= remission, \\<3.2= low disease activity, greater than or equal to (\\>=) 3.2 to 5.1= moderate disease activity and \\>5.1= high disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who had taken at least 1 dose of study medication. Here, "n" signifies number of participants who were evaluable for specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.'}], 'classes': [{'title': 'Baseline (n =186)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 4 (n =186)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.39', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 12 (n =179)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.48', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 24 (n =161)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.56', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, 12, 24', 'description': 'HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who had taken at least 1 dose of study medication. Here, "n" signifies number of participants who were evaluable for specified time points.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '8.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 24', 'description': 'Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etanercept', 'description': 'Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Randomized But Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Etanercept', 'description': 'Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.2', 'spread': '12.89', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '159', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants who had taken at least 1 dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-10', 'studyFirstSubmitDate': '2015-02-13', 'resultsFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2015-02-26', 'lastUpdatePostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-10', 'studyFirstPostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12', 'timeFrame': 'Week 12', 'description': 'Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.'}, {'measure': 'Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24', 'timeFrame': 'Week 24', 'description': 'Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.'}, {'measure': 'Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment', 'timeFrame': 'Baseline up to Week 24', 'description': 'Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment', 'timeFrame': 'Baseline (Day 1) up to Week 24', 'description': 'Percentage of participants with positive Etanercept neutralizing anti-drug antibodies were summarized.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline (Day 1) up to Week 28 (Follow-up)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.'}, {'measure': 'Number of Participants With Investigator-Identified Serious Infections', 'timeFrame': 'Baseline (Day 1) up to Week 28 (Follow-up)', 'description': 'Infection was considered as serious by investigator for any of the following outcomes: death; life-threatening; required initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity or congenital anomaly/birth defect.'}, {'measure': 'Number of Participants With Injection Site Reactions', 'timeFrame': 'Baseline (Day 1) up to Week 28 (Follow-up)', 'description': 'Injection site reactions included injection site erythema, swelling, pain and warmth.'}, {'measure': 'Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities', 'timeFrame': 'Baseline (Day 1) up to Week 28 (Follow-up)', 'description': 'Laboratory abnormalities(national cancer institute toxicity criteria version 4.0),Grade 3:neutrophil (greater than or equal to\\[\\>=\\]0.5,less than\\[\\<\\]1.0 10\\^9/L),lymphocyte (\\<0.5 10\\^9/L),hemoglobin (Hb) (\\<80,\\>=65 gram per liter \\[g/L\\]),platelet(\\<50.0,\\>=25.0 10\\^9/L),white blood count(WBC) (\\<2.0, \\>=1.0 10\\^9/L);alkaline phosphatase (AP),aspartate aminotransferase(AST),alanine aminotransferase(ALT) (greater than\\[\\>\\]5.0\\*upper range \\[UR\\], \\<=20.0\\*UR unit per liter\\[U/L\\]);bilirubin(\\>1.5\\*UR, less than or equal to\\[\\<=\\]3.0\\*UR micromole per liter\\[mcmol/L\\]);creatinine(\\>3.0\\*UR, \\<=6.0\\*UR mcmol/L);albumin (\\<20.0 g/L),urea(\\>3.0\\*UR, \\<=4.0\\*UR g/L);potassium (K)-high,low (\\>6.0,\\<=7.0or\\<3.0,\\>=2.5 mcmol/L); sodium(Na)-high,low(\\>155, \\<=160 or \\<130, \\>=120 mcmol/L)and Grade 4: neutrophil(\\<0.5 10\\^9/L),Hb (\\<65 g/L);platelet (\\<25.0 10\\^9/L); WBC(\\<1.0 10\\^9/L);AP,AST,ALT(\\>20.0\\*UR U/L);bilirubin(\\>3.0\\*UR mcmol/L);creatinine (\\>6.0\\*UR mcmol/L);urea (\\>4.0\\*UR g/L);K-high,low (\\>7.0or\\<2.5 mcmol/L);Na-high, low (\\>160or\\<120 mcmol/L).'}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response', 'timeFrame': 'Week 4, 12, 24', 'description': "ACR20 responder: participants with 20 percent (%) improvement in tender and swollen 28-joint counts and 20% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR20 response were reported."}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response', 'timeFrame': 'Week 4, 12, 24', 'description': "ACR50 responder: participants with 50% improvement in tender and swollen 28-joint counts and 50% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR50 response were reported."}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response', 'timeFrame': 'Week 4, 12, 24', 'description': "ACR70 responder: participants with 70% improvement in tender and swollen 28-joint counts and 70% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR70 response were reported."}, {'measure': 'Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24', 'timeFrame': 'Baseline, Week 4, 12, 24', 'description': "DAS28: measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, erythrocyte sedimentation rate (millimeter per hour \\[mm/hour\\]) and participant's general health visual analog scale assessment (scores: 0 mm \\[very well\\] to 100 mm \\[extremely bad\\], higher scores indicate worse health condition). Total DAS28-4 (ESR) score: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (ESR) less than (\\<) 2.6= remission, \\<3.2= low disease activity, greater than or equal to (\\>=) 3.2 to 5.1= moderate disease activity and \\>5.1= high disease activity."}, {'measure': 'Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24', 'timeFrame': 'Baseline, Week 4, 12, 24', 'description': "DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from the number of swollen joints and tender joints using the 28 joints count, C-Reactive protein (milligram per liter \\[mg/L\\]) and participant's general health visual analog scale assessment (scores ranging 0 mm \\[very well\\] to 100 mm \\[extremely bad\\], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (CRP) less than (\\<) 2.6= remission, \\<3.2= low disease activity, greater than or equal to (\\>=) 3.2 to 5.1= moderate disease activity and \\>5.1= high disease activity."}, {'measure': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24', 'timeFrame': 'Baseline, Week 4, 12, 24', 'description': 'HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthritis, Rheumatoid']}, 'referencesModule': {'references': [{'pmid': '30451655', 'type': 'DERIVED', 'citation': 'Polak P, Peric P, Louw I, Gaylord SM, Williams T, Becker JC, Pedersen R, Korth-Bradley J, Vlahos B. A single-arm, open-label study to assess the immunogenicity, safety, and efficacy of etanercept manufactured using the serum-free, high-capacity manufacturing process administered to patients with rheumatoid arthritis. Eur J Rheumatol. 2019 Jan;6(1):23-28. doi: 10.5152/eurjrheum.2018.18078.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801359&StudyName=Study%20to%20Assess%20the%20Immunogenicity%2C%20Safety%2C%20and%20Efficacy%20of%20Etanercept%20Manufactured%20Using%20the%20High%20Capacity%20Process%20Administered%20to%20Rh', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the high capacity process. Descriptive results will be provided however a formal hypothesis will not be tested in this trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe active disease with presence of at least 4 tender joints and 4 swollen joints.\n* Either the patient or a designee must be capable of administering the subcutaneous injection of study drug.\n\nExclusion Criteria:\n\n* Prior treatment with etanercept.\n* Presence of active infection or active or untreated tuberculosis.'}, 'identificationModule': {'nctId': 'NCT02378506', 'briefTitle': 'Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Single-arm, Open-label Study To Assess The Immunogenicity, Safety, And Efficacy Of Etanercept Manufactured Using The High Capacity Process Administered To Subjects With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'B1801359'}, 'secondaryIdInfos': [{'id': '2013-004569-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ETN 50mg QW', 'interventionNames': ['Biological: etanercept']}], 'interventions': [{'name': 'etanercept', 'type': 'BIOLOGICAL', 'description': '50mg subcutaneous, once weekly, 24 weeks', 'armGroupLabels': ['ETN 50mg QW']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'MHAT Plovdiv', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'DCC "Aleksandrovska" EOOD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1612', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'UMHAT "Sv. Ivan Rilski" EAD, Sofia', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '6000', 'city': 'Stara Zagora', 'country': 'Bulgaria', 'facility': 'Medical Center - "New rehabilitation center" EOOD', 'geoPoint': {'lat': 42.43205, 'lon': 25.64262}}, {'zip': '51000', 'city': 'Rijeka', 'country': 'Croatia', 'facility': 'Chc Rijeka', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Medicinski Centar Kuna Peric', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '60528', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Centrum für innovative Diagnostik und Therapie', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '40882', 'city': 'Ratingen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Rheumaforschung - Studienambulanz Dr. Wassenberg', 'geoPoint': {'lat': 51.29724, 'lon': 6.84929}}, {'zip': '14059', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Schlosspark-Klinik, Innere Medizin II, Rheumatologie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '39245', 'city': 'Vogelsang-Gommern', 'country': 'Germany', 'facility': 'Immunologisches Zentrum Vogelsang-Gommern GmbH'}, {'zip': '26500', 'city': 'Rion Patras', 'state': 'Achaia', 'country': 'Greece', 'facility': 'Rheumatology Department'}, {'zip': '71110', 'city': 'Heraklion', 'state': 'Crete', 'country': 'Greece', 'facility': 'University Hospital of Heraklion', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}, {'zip': '56429', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Rheumatology Unit', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '1036', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Qualiclinic Kft.', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '2143', 'city': 'Kistarcsa', 'country': 'Hungary', 'facility': 'Pest Megyei Flor Ferenc Korhaz', 'geoPoint': {'lat': 47.54757, 'lon': 19.26247}}, {'zip': '4400', 'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': 'Szabolcs-Szatmar-Bereg megyei', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'zip': '31-501', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Krakowskie Centrum Medyczne sp. Z.O.O', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '05-830', 'city': 'Nadarzyn', 'country': 'Poland', 'facility': 'NZOZ Lecznica MAK-MED s.c.', 'geoPoint': {'lat': 52.09438, 'lon': 20.80776}}, {'zip': '61-397', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Prywatna Praktyka Lekarska Prof. UM dr hab.med. Pawel Hrycaj', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '02-691', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Reumatika-Centrum Reumatologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '11000', 'city': 'Belgrade', 'state': 'Beograd', 'country': 'Serbia', 'facility': 'Institute of Rheumatology', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '841 04', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Reumatologicka ambulancia', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '929 01', 'city': 'Dunajská Streda', 'country': 'Slovakia', 'facility': 'AAGS, s.r.o.', 'geoPoint': {'lat': 47.99268, 'lon': 17.61211}}, {'zip': '058 01', 'city': 'Poprad', 'country': 'Slovakia', 'facility': 'Reumatologicka ambulancia, MUDr. Zuzana Cizmarikova, s.r.o.', 'geoPoint': {'lat': 49.06144, 'lon': 20.29798}}, {'zip': '979 01', 'city': 'Rimavská Sobota', 'country': 'Slovakia', 'facility': 'REUMEX s.r.o.', 'geoPoint': {'lat': 48.38284, 'lon': 20.02239}}, {'zip': '917 01', 'city': 'Trnava', 'country': 'Slovakia', 'facility': 'REUMA-GLOBAL s.r.o.', 'geoPoint': {'lat': 48.37773, 'lon': 17.58603}}, {'zip': '010 01', 'city': 'Žilina', 'country': 'Slovakia', 'facility': 'Reumatologicka ambulancia', 'geoPoint': {'lat': 49.22315, 'lon': 18.73941}}, {'zip': '7500', 'city': 'Panorama', 'state': 'Cape Town', 'country': 'South Africa', 'facility': 'Panorama Medical Centre', 'geoPoint': {'lat': -28.75383, 'lon': 31.89113}}, {'zip': '2193', 'city': 'Parktown', 'state': 'Johannesburg', 'country': 'South Africa', 'facility': 'Wits Clinical Research CMJAH Clinical Trial Site', 'geoPoint': {'lat': -26.18205, 'lon': 28.02671}}, {'zip': '4001', 'city': 'Durban/Berea', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'St. Augustines Hospital'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}