Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-04-23 @ 6:04 PM
Study NCT ID:
NCT02638259
Status:
COMPLETED
Last Update Posted:
2018-09-19
First Post:
2015-12-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With 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': 'C000628566', 'term': 'GP2015'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'biopharma.clinicaltrials@sandoz.com', 'phone': '0049(0)80244760', 'title': 'Sandoz Biopharma Clinical Development - Strategic Planning', 'organization': 'Sandoz'}, 'certainAgreement': {'otherDetails': 'Terms related to publication are part of the contract templates between Sponsor and sites/investigators. In general, these terms outlined that authorship of any publications relating to the clinical study shall be determined by agreement with the Sponsor. Sponsor reserves the right to request amendments or deletions to proposed publications, or request that any publication or presentation be delayed up to four months. A very limited number of exceptions can be granted to modify these terms.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 1.5 years.', 'description': 'AE additional description', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Period 1 TP1 SAF GP2015', 'description': 'Treatment Period 1 TP1 SAF GP2015', 'otherNumAtRisk': 186, 'deathsNumAtRisk': 186, 'otherNumAffected': 52, 'seriousNumAtRisk': 186, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Treatment Period 1 TP1 SAF Enbrel', 'description': 'Treatment Period 1 TP1 SAF Enbrel', 'otherNumAtRisk': 190, 'deathsNumAtRisk': 190, 'otherNumAffected': 64, 'seriousNumAtRisk': 190, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Treatment Period 2 TP2 SAF Continued GP2015', 'description': 'Treatment Period 2 TP2 SAF Continued GP2015', 'otherNumAtRisk': 175, 'deathsNumAtRisk': 175, 'otherNumAffected': 42, 'seriousNumAtRisk': 175, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Treatment Period 2 TP2 SAF Enbrel Switched to GP2015', 'description': 'Treatment Period 2 TP2 SAF Enbrel switched to GP2015', 'otherNumAtRisk': 166, 'deathsNumAtRisk': 166, 'otherNumAffected': 37, 'seriousNumAtRisk': 166, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Entire Study SAF GP2015', 'description': 'Entire study SAF GP2015', 'otherNumAtRisk': 186, 'deathsNumAtRisk': 186, 'otherNumAffected': 79, 'seriousNumAtRisk': 186, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG005', 'title': 'Entire Study SAF Enbrel/GP2015', 'description': 'Entire study SAF Enbrel/GP2015', 'otherNumAtRisk': 190, 'deathsNumAtRisk': 190, 'otherNumAffected': 81, 'seriousNumAtRisk': 190, 'deathsNumAffected': 1, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Salivary gland cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cystitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety: Change in DAS28-CRP Score From Baseline to Week 24 in Patients Treated With GP2015 and Patients Treated With Enbrel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.80', 'spread': '0.113', 'groupId': 'OG000'}, {'value': '-2.73', 'spread': '0.117', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.097', 'groupDescription': 'Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 24 will be concluded if the 95% confidence interval for the LS mean difference between GP2015 and Enbrel is contained within the interval \\[-0.6; 0.6\\]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A margin of 0.6 can be statistically and clinically justified based on the results Keystone et al, Arthritis and Rheumatism, p353-363, (2004) and on the EULAR response criteria. The sample size of 155 per group with 90% power is based on the common SD of 1.46 and was calculated using nQuery 7.0.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'treatment period 1: up to 24 weeks', 'description': "Disease activity score (DAS) 28-CRP is based on 28-joint count (tender and swollen joints), C-reactive protein and patient's assessment of global disease activity, values range from 0.96 to 10.0 while higher values mean a higher disease activity. • A DAS28-CRP value \\>5.1 corresponds to a high disease activity • A DAS28-CRP value between 3.2 and 5.1 corresponds to a moderate disease activity • A DAS28-CRP value between 2.6 and 3.2 corresponds to a low disease activity • A DAS28-CRP value \\< 2.6 corresponds to remission DAS28-CRP = 0.56 \\* sqrt(tender28) + 0.28\\* sqrt(swollen28) + 0.36 \\* ln(CRP+1) + 0.014 \\* GDA + 0.96 where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment Period 1 Per-Protocol set'}, {'type': 'SECONDARY', 'title': 'Treatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'All injection site reactions', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Moderate injection site reactions', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Severe injection site reactions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Treatment Period 1, up to 24 weeks', 'description': 'Frequency of participants with injection site reactions in GP2015 and Enbrel', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}, {'type': 'SECONDARY', 'title': 'Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, week 2, week 4, week 12, week 24', 'description': 'Frequency of patients having anti-drug antibody (ADA) during 24 weeks (Treatment Period 1) using 1% false positive rate', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}, {'type': 'SECONDARY', 'title': 'Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'DAS28-CRP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.42', 'spread': '0.921', 'groupId': 'OG000'}, {'value': '5.53', 'spread': '0.783', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.81', 'spread': '1.079', 'groupId': 'OG000'}, {'value': '3.82', 'spread': '1.077', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.15', 'spread': '1.045', 'groupId': 'OG000'}, {'value': '3.31', 'spread': '1.088', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.63', 'spread': '0.910', 'groupId': 'OG000'}, {'value': '2.75', 'spread': '0.928', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.34', 'spread': '0.882', 'groupId': 'OG000'}, {'value': '6.41', 'spread': '0.768', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.62', 'spread': '1.183', 'groupId': 'OG000'}, {'value': '4.56', 'spread': '1.204', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.84', 'spread': '1.216', 'groupId': 'OG000'}, {'value': '3.94', 'spread': '1.284', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.24', 'spread': '1.060', 'groupId': 'OG000'}, {'value': '3.32', 'spread': '1.099', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 4, 12, 24', 'description': 'DAS28-CRP is a disease activity score and defined in primary outcome measure. DAS28-ESR is the DAS28 erythrocyte sedimentation rate score.\n\nDAS28-CRP and DAS28-ESR:\n\n1. best is 0,\n2. \\< 2.6 - remission,\n3. ≥ 2.6 to ≤ 3.2 - low disease activity\n4. \\> 3.2 to ≤ 5.1 - moderate disease activity\n5. \\> 5.1 - high disease activity\n\nDAS28-ESR = 0.56 \\* sqrt(tender28) + 0.28\\* sqrt(swollen28) + 0.7 \\* ln(ESR) + 0.014 \\* GDA where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • ESR is erythrocyte sedimentation rate (mm/h) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 1 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'DAS28-CRP change from baseline week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.59', 'spread': '1.032', 'groupId': 'OG000'}, {'value': '-1.70', 'spread': '1.001', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP change from baseline week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.23', 'spread': '1.030', 'groupId': 'OG000'}, {'value': '-2.20', 'spread': '1.071', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP change from baseline week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.78', 'spread': '1.058', 'groupId': 'OG000'}, {'value': '-2.78', 'spread': '1.028', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR change from baseline week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.72', 'spread': '1.068', 'groupId': 'OG000'}, {'value': '-1.85', 'spread': '1.078', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR change from baseline week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.50', 'spread': '1.145', 'groupId': 'OG000'}, {'value': '-2.47', 'spread': '1.218', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR change from baseline week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.10', 'spread': '1.157', 'groupId': 'OG000'}, {'value': '-3.09', 'spread': '1.119', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, Week 4, week 12, week 24', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 1 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 1- Proportion of Patients Achieving EULAR Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Good response week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Good response week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Good response week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Moderate response week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}, {'title': 'Moderate response week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': 'Moderate response week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'no response week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'no response week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'no response week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 4, week 12 and week 24', 'description': 'Proportion of patients achieving European League against Rheumatism (EULAR) good response (defined as DAS28 ≤ 3.2 and DAS28 improvement from Baseline \\> 1.2) and moderate response (defined as DAS28 ≤ 3.2 and DAS28 improvement \\> 0.6 and ≤ 1.2, or DAS28 \\> 3.2 and ≤ 5.1 and DAS28 improvement \\> 0.6 or DAS28 \\> 5.1 but DAS28 improvement \\> 1.2) ;', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 1 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 1- Proportion of Patients Achieving DAS28 < 2.6 at Weeks 4, 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Week 4 - remission (DAS28 <2.6)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 - remission (DAS28 <2.6)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 - remission (DAS28 <2.6)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 4, week 12 and week 24', 'description': '% patients in DAS28-ESR categories up to week 24', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 1 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 4, week 12, week 24', 'description': 'Proportion of patients achieving EULAR/American College of Rheumatology (EULAR/ACR) Boolean remission criteria (defined as number of tender joints/swollen joints ≤ 1 and CRP (mg/dL) ≤ 1 and patient global assessment (1-10) ≤ 1) at Weeks 4, 12 and 24;', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 1 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'ACR20 response Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'ACR20 response Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}, {'title': 'ACR20 response Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}, {'title': 'ACR50 response Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'ACR50 response Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'ACR50 response Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'ACR70 response Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'ACR70 response Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'ACR70 response Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4, week 12 and week 24', 'description': 'ACR20 response was defined if a patient fulfilled all 3 criteria below:\n\n* 20% improvement in tender 68 joint-count\n* 20% improvement in swollen 68 joint-count;\n\nAnd 20% improvement in at least 3 of the following 5 measures:\n\n* Patient\'s assessment of RA pain (visual analogue scale (VAS) 100 mm),\n* Patient\'s global assessment of disease activity (VAS 100 mm),\n* Physician\'s global assessment of disease activity (VAS 100 mm),\n* Patient self-assessed disability (HAQ score),\n* Acute phase reactant (CRP or ESR). ACR50 and ACR70 responses were defined as ACR20 response replacing "20% improvement" by "50% improvement" and "70% improvement", respectively.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 1 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 1- ACR-N Scores at Weeks 4, 12 and 24;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.9', 'spread': '29.89', 'groupId': 'OG000'}, {'value': '22.6', 'spread': '34.02', 'groupId': 'OG001'}]}]}, {'title': 'week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.3', 'spread': '27.46', 'groupId': 'OG000'}, {'value': '38.7', 'spread': '35.32', 'groupId': 'OG001'}]}]}, {'title': 'week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.4', 'spread': '27.61', 'groupId': 'OG000'}, {'value': '59.4', 'spread': '25.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 12 and 24;', 'description': 'ACR-N (American College of Rheumatology percentage of improvement): negative is worsening, positive (up to 100) is an improvement.\n\nACR-N is a single number that characterizes the percentage of improvement from Baseline that a patient has experienced in analogy to ACR20 described above. ACR-N of X (such as 38) means that the patient had achieved an improvement of at least X% (such as 38%) in tender and swollen joints, and an improvement of at least X% (such as 38%) in 3 of the 5 other parameters mentioned above.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 1 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Baseline : Remission (SDAI<=3.3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Low (3.3 < SDAI <= 11)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline : Moderate (11 < SDAI <= 26', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Baseline : High (SDAI > 26)', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}]}, {'title': 'Week 4:Remission (SDAI<=3.3)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 4:Low (3.3 < SDAI <= 11)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: Moderate (11 < SDAI <= 26', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Week 4:High (SDAI > 26)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Week 12:Remission (SDAI<=3.3)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 12:Low (3.3 < SDAI <= 11)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Moderate (11 < SDAI <= 26', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'Week 12:High (SDAI > 26)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Remission (SDAI<=3.3)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Low (3.3 < SDAI <= 11)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 : Moderate (11 < SDAI <= 26', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 :High (SDAI > 26)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 4, 12 and 24;', 'description': "Proportion of patients in each disease activity category as defined by the Simplified Disease Activity Index (SDAI): high disease activity, SDAI \\> 26, moderate disease activity, SDAI \\> 11 to ≤ 26, low disease activity, SDAI \\> 3.3 to ≤ 11, and remission, SDAI ≤ 3.3 at Weeks 4, 12 and 24; SDAI and CDAI are measures of disease activity in RA. The scores were calculated by numerical summation of the number of tender and swollen joints (using the 28-joint count), and the patient's and physician's global assessment of disease activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 1 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Baseline : Remission (CDAI<=2.8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Low (2.8 < CDAI <= 10)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline : Moderate (10 < CDAI <= 22', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Baseline : High (CDAI > 22)', 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}]}, {'title': 'Week 4:Remission(CDAI<=2.8)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: Low (2.8 < CDAI <= 10)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: Moderate (10 < CDAI <= 22)', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Week 4:High High (CDAI > 22)', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Week 12:Remission(CDAI<=2.8)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Low (2.8 < CDAI <= 10)', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Moderate (10 < CDAI <= 22)', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Week 12:High (CDAI > 22)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Remission (CDAI<=2.8)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Low (2.8 < CDAI <= 10)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 : (10 < CDAI <= 22)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 :High (CDAI > 22)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 4, 12 and 24;', 'description': "Proportion of patients in each disease activity category as defined by the Clinical Disease Activity Index (CDAI): high disease activity, CDAI \\> 22, moderate disease activity, CDAI \\> 10 to ≤ 22, low disease activity, CDAI \\> 2.8 to ≤ 10, and remission, CDAI ≤ 2.8 at Weeks 4, 12 and 24; SDAI and CDAI are measures of disease activity in RA. The scores were calculated by numerical summation of the number of tender and swollen joints (using the 28-joint count), and the patient's and physician's global assessment of disease activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 1 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 1- Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 4, 12 and 24;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 4, 12 and 24;', 'description': 'Health assessment questionnaire (HAQ) disability index ranges from 0 (best) to 3 (worst)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 1 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 1 - Health Assessment Questionnaire (HAQ) Index at Baseline, Weeks 4, 12 and 24;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.44', 'spread': '0.547', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '0.561', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.19', 'spread': '0.558', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '0.611', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.02', 'spread': '0.560', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.599', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.601', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '0.589', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 12 and 24;', 'description': 'Health assessment questionnaire (HAQ) disability index ranges from 0 (best) to 3 (worst)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 1 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.0', 'spread': '9.67', 'groupId': 'OG000'}, {'value': '25.1', 'spread': '10.33', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.6', 'spread': '8.83', 'groupId': 'OG000'}, {'value': '30.9', 'spread': '10.01', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.4', 'spread': '8.93', 'groupId': 'OG000'}, {'value': '33.9', 'spread': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.3', 'spread': '8.94', 'groupId': 'OG000'}, {'value': '36.7', 'spread': '9.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 12 and 24;', 'description': 'FACIT fatigue scale is a 13- item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function, ranging from 0 (worst) to 52 (best). A score of less than 30 indicates severe fatigue.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 1 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.19', 'spread': '2.194', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '1.526', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.718', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.693', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.772', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.850', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.949', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.466', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 12 and 24', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 1 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.4', 'spread': '16.89', 'groupId': 'OG000'}, {'value': '41.8', 'spread': '17.94', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.5', 'spread': '16.51', 'groupId': 'OG000'}, {'value': '26.7', 'spread': '17.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.2', 'spread': '14.67', 'groupId': 'OG000'}, {'value': '23.8', 'spread': '15.41', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.4', 'spread': '15.47', 'groupId': 'OG000'}, {'value': '20.8', 'spread': '14.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 12 and 24', 'unitOfMeasure': 'mm/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 1 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'DAS28-CRP Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.45', 'spread': '0.914', 'groupId': 'OG000'}, {'value': '5.57', 'spread': '0.794', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.89', 'spread': '1.053', 'groupId': 'OG000'}, {'value': '3.79', 'spread': '1.101', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.20', 'spread': '1.038', 'groupId': 'OG000'}, {'value': '3.27', 'spread': '1.127', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.64', 'spread': '0.863', 'groupId': 'OG000'}, {'value': '2.67', 'spread': '0.892', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.65', 'spread': '1.001', 'groupId': 'OG000'}, {'value': '2.74', 'spread': '1.017', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.57', 'spread': '1.067', 'groupId': 'OG000'}, {'value': '2.74', 'spread': '1.062', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.39', 'spread': '0.872', 'groupId': 'OG000'}, {'value': '6.43', 'spread': '0.784', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.70', 'spread': '1.175', 'groupId': 'OG000'}, {'value': '4.49', 'spread': '1.228', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.90', 'spread': '1.236', 'groupId': 'OG000'}, {'value': '3.85', 'spread': '1.317', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.23', 'spread': '1.022', 'groupId': 'OG000'}, {'value': '3.19', 'spread': '1.048', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.25', 'spread': '1.160', 'groupId': 'OG000'}, {'value': '3.28', 'spread': '1.127', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.20', 'spread': '1.201', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '1.177', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 4, week 12, week 24, week 36 and week 48.', 'description': 'DAS28-CRP and DAS28-ESR:\n\n1. best is 0,\n2. \\< 2.6 - remission,\n3. ≥ 2.6 to ≤ 3.2 - low disease activity\n4. \\> 3.2 to ≤ 5.1 - moderate disease activity\n5. \\> 5.1 - high disease activity', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 2 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'DAS28-CRP change from baseline, week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.55', 'spread': '1.014', 'groupId': 'OG000'}, {'value': '-1.76', 'spread': '1.014', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP change from baseline, week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.22', 'spread': '1.031', 'groupId': 'OG000'}, {'value': '-2.27', 'spread': '1.096', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP change from baseline, week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.81', 'spread': '1.007', 'groupId': 'OG000'}, {'value': '-2.90', 'spread': '0.988', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP change from baseline, week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.80', 'spread': '1.087', 'groupId': 'OG000'}, {'value': '-2.82', 'spread': '1.151', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP change from baseline, week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.88', 'spread': '1.198', 'groupId': 'OG000'}, {'value': '-2.83', 'spread': '1.176', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR change from baseline, week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.69', 'spread': '1.048', 'groupId': 'OG000'}, {'value': '-1.92', 'spread': '1.087', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR change from baseline, week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.49', 'spread': '1.152', 'groupId': 'OG000'}, {'value': '-2.57', 'spread': '1.235', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR change from baseline, week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.16', 'spread': '1.106', 'groupId': 'OG000'}, {'value': '-3.23', 'spread': '1.054', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR change from baseline, week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.13', 'spread': '1.232', 'groupId': 'OG000'}, {'value': '-3.14', 'spread': '1.154', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-ESR change from baseline, week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.20', 'spread': '1.297', 'groupId': 'OG000'}, {'value': '-3.14', 'spread': '1.190', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 4, week 12, week 24, week 36, week 48', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 2 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 2: Proportion of Patients Achieving EULAR Reponse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Good response week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Good response week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Good response week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'Good response week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Good response week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Moderate response week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Moderate response week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Moderate response week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Moderate response week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Moderate response week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'no response week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'no response week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'no response week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'no response week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'no response week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 4, week 12, week 24, week 36 and week 48', 'description': 'Proportion of patients achieving EULAR good response (defined as DAS28 ≤ 3.2 and DAS28 improvement from Baseline \\> 1.2) and moderate response (defined as DAS28 ≤ 3.2 and DAS28 improvement \\> 0.6 and ≤ 1.2, or DAS28 \\> 3.2 and ≤ 5.1 and DAS28 improvement \\> 0.6 or DAS28 \\> 5.1 but DAS28 improvement \\> 1.2) at Weeks 36 and 48;', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 2 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 2 : Proportion of Patients Achieving DAS28 < 2.6 at Weeks 36 and 48;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Week 36 Remission (DAS28 < 2.6)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 Remission (DAS28 < 2.6)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 36 and week 48', 'description': 'percentage of participants in DAS28-ESR categories up to week 48', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 2 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 4, week 12, week 24, week 36, week 48', 'description': 'Proportion of patients achieving EULAR/ACR Boolean remission criteria (defined as number of tender joints/swollen joints ≤ 1 and CRP (mg/dL) ≤ 1 and patient global assessment (1-10) ≤ 1) at Weeks 36 and 48;', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 2 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'ACR20 response Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': 'ACR20 response Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}, {'title': 'ACR50 response Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'ACR50 response Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'ACR70 response Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'ACR70 response Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 36 and week 48', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 2 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 2 : ACR-N Scores at Weeks 36 and 48;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.7', 'spread': '27.72', 'groupId': 'OG000'}, {'value': '24.9', 'spread': '29.40', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.3', 'spread': '27.84', 'groupId': 'OG000'}, {'value': '40.7', 'spread': '34.80', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.3', 'spread': '26.58', 'groupId': 'OG000'}, {'value': '60.9', 'spread': '24.79', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.8', 'spread': '28.21', 'groupId': 'OG000'}, {'value': '55.7', 'spread': '28.37', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.9', 'spread': '29.18', 'groupId': 'OG000'}, {'value': '56.4', 'spread': '30.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 36 and week 48', 'description': 'ACR-N: negative is worsening, positive (up to 100) is an improvement', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 2 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Baseline : Remission (SDAI <= 3.3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline : Low (3.3 < SDAI <= 11)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline : Moderate (11 < SDAI <= 26)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Baseline : High (SDAI > 26 )', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 : Remission (SDAI <= 3.3)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 : Low (3.3 < SDAI <= 11)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 : Moderate (11 < SDAI <= 26', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 : High (SDAI > 26 )', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Remission (SDAI <= 3.3)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 : Low (3.3 < SDAI <= 11)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 : Moderate (11 < SDAI <= 26', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 : High (SDAI > 26 )', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Remission (SDAI <= 3.3)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 : Low (3.3 < SDAI <= 11)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 : Moderate (11 < SDAI <= 26', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 : High (SDAI > 26 )', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 36: Remission (SDAI <= 3.3)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 : Low (3.3 < SDAI <= 11', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 : Moderate (11 < SDAI <= 26', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 : High (SDAI > 26 )', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 48: Remission (SDAI <= 3.3)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 : Low (3.3 < SDAI <= 11', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 : Moderate (11 < SDAI <= 26', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 : High (SDAI > 26 )', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, week 4, week 12, week 24, week 36. week 48', 'description': 'Proportion of patients in each disease activity category as defined by the Simplified Disease Activity Index (SDAI): high disease activity, SDAI \\> 26, moderate disease activity, SDAI \\> 11 to ≤ 26, low disease activity, SDAI \\> 3.3 to ≤ 11, and remission, SDAI ≤ 3.3 at Weeks 36 and 48.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 2 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Baseline : Remission (CDAI <=2.8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline : Low (2.8 < CDAI <= 10)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline : Moderate (10 < CDAI <= 22)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Baseline : High (CDAI > 22 )', 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 : Remission (CDAI <=2.8)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 : Low (2.8 < CDAI <= 10)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 : Moderate (11 < SDAI <= 26', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 : High (CDAI > 22 )', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Remission (CDAI <=2.8)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 : Low (2.8 < CDAI <= 10)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 : Moderate (10 < CDAI <= 22)', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 : High (CDAI > 22 )', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Remission (CDAI <=2.8)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 : Low (2.8 < CDAI <= 10)', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 : Moderate (10 < CDAI <= 22)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 : High (CDAI > 22 )', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 36: Remission (CDAI <=2.8)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 : Low (2.8 < CDAI <= 10)', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 : Moderate (10 < CDAI <= 22)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 : High (CDAI > 22 )', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 48: Remission (CDAI <=2.8)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 : Low (2.8 < CDAI <= 10)', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 : Moderate (10 < CDAI <= 22)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 : High (CDAI > 22 )', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, week 4, week 12, week 24, week 36 and week 48', 'description': 'Proportion of patients in each disease activity category as defined by the Clinical Disease Activity Index (CDAI): high disease activity, CDAI \\> 22, moderate disease activity, CDAI \\> 10 to ≤ 22, low disease activity, CDAI \\> 2.8 to ≤ 10, and remission, CDAI ≤ 2.8 at Weeks 36 and 48;', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 2 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, week 4, week 12, week 24, week 36, week 48', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 2 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 2 :HAQ Index at Weeks 36 and 48;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.547', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '0.554', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.22', 'spread': '0.554', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '0.620', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.04', 'spread': '0.560', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.614', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.594', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.603', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.89', 'spread': '0.584', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '0.651', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.85', 'spread': '0.609', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.652', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, week 4, week 12, week 24, week 36, week 48', 'description': 'HAQ: from 0 (best) to 3 (worst)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 2 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.6', 'spread': '9.71', 'groupId': 'OG000'}, {'value': '25.5', 'spread': '10.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.5', 'spread': '8.72', 'groupId': 'OG000'}, {'value': '31.3', 'spread': '10.07', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.4', 'spread': '8.89', 'groupId': 'OG000'}, {'value': '34.1', 'spread': '9.69', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.6', 'spread': '8.75', 'groupId': 'OG000'}, {'value': '36.7', 'spread': '9.05', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.9', 'spread': '8.79', 'groupId': 'OG000'}, {'value': '36.4', 'spread': '9.50', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.0', 'spread': '8.74', 'groupId': 'OG000'}, {'value': '35.8', 'spread': '9.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, week 4, week 12, week 24, week 36, week 48', 'description': 'FACIT: from 0 (worst) to 52 (best), a score of less than 30 indicates severe fatigue', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 2 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 2 : CRP Levels at Week 36 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.21', 'spread': '2.244', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '1.589', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.733', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.625', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.817', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.910', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.964', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.487', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.758', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.655', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.623', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.878', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, week 4, week 12, week 24, week 36, week 48', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 2 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Treatment Period 2 : ESR Levels at Week 36 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.2', 'spread': '16.99', 'groupId': 'OG000'}, {'value': '41.7', 'spread': '17.99', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.8', 'spread': '16.33', 'groupId': 'OG000'}, {'value': '25.3', 'spread': '16.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.8', 'spread': '15.07', 'groupId': 'OG000'}, {'value': '23.0', 'spread': '15.38', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.3', 'spread': '15.66', 'groupId': 'OG000'}, {'value': '19.3', 'spread': '12.66', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.1', 'spread': '16.41', 'groupId': 'OG000'}, {'value': '20.3', 'spread': '14.28', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.8', 'spread': '16.66', 'groupId': 'OG000'}, {'value': '20.8', 'spread': '14.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, week 4, week 12, week 24, week 36, week 48', 'unitOfMeasure': 'mm/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment period 2 per protocol set. Patients with data available'}, {'type': 'SECONDARY', 'title': 'Safety - Overall Study : Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'participants with at least one ISR', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'participants with at least one moderate ISR', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'participants with at least one severe ISR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 48 weeks', 'description': 'Frequency of participants with injection site reactions in GP2015 and Enbrel', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}, {'type': 'SECONDARY', 'title': 'Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'OG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, week 4, week 12, week 24, week 36, week 48', 'description': 'To assess the immunogenicity of continuous GP2015 treatment versus a treatment transition from Enbrel to GP2015 after 24 weeks of treatment by measuring the rate of ADA positive participants at Weeks 24, 30, 36 and 48. summary of ADA positive data up to week 48 using a 1% false positive cut point', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'FG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 will receive treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response will be switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}], 'periods': [{'title': 'Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '190'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '172'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawn per sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '6 patients did not proceed to TP2 (3 not eligible, 2 consent withdrawal, 1 IP delay)', 'groupId': 'FG000', 'numSubjects': '175'}, {'comment': '6 patients did not proceed to TP2 (4 not eligible, 1 consent withdrawal, 1 adverse event).', 'groupId': 'FG001', 'numSubjects': '166'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}, {'groupId': 'FG001', 'numSubjects': '155'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '376', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '50mg GP2015', 'description': 'Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'BG001', 'title': '50mg EU-authorized Enbrel', 'description': 'Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '11.22', 'groupId': 'BG000'}, {'value': '53.1', 'spread': '12.70', 'groupId': 'BG001'}, {'value': '54.1', 'spread': '12.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hungary', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Latvia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Lithuania', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Estonia', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics are presented for Full Analysis Set (FAS). The FAS is comprised of all randomized patients to whom study treatment has been assigned.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 376}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-18', 'studyFirstSubmitDate': '2015-12-16', 'resultsFirstSubmitDate': '2017-12-19', 'studyFirstSubmitQcDate': '2015-12-18', 'lastUpdatePostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-26', 'studyFirstPostDateStruct': {'date': '2015-12-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Change in DAS28-CRP Score From Baseline to Week 24 in Patients Treated With GP2015 and Patients Treated With Enbrel', 'timeFrame': 'treatment period 1: up to 24 weeks', 'description': "Disease activity score (DAS) 28-CRP is based on 28-joint count (tender and swollen joints), C-reactive protein and patient's assessment of global disease activity, values range from 0.96 to 10.0 while higher values mean a higher disease activity. • A DAS28-CRP value \\>5.1 corresponds to a high disease activity • A DAS28-CRP value between 3.2 and 5.1 corresponds to a moderate disease activity • A DAS28-CRP value between 2.6 and 3.2 corresponds to a low disease activity • A DAS28-CRP value \\< 2.6 corresponds to remission DAS28-CRP = 0.56 \\* sqrt(tender28) + 0.28\\* sqrt(swollen28) + 0.36 \\* ln(CRP+1) + 0.014 \\* GDA + 0.96 where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm"}], 'secondaryOutcomes': [{'measure': 'Treatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel', 'timeFrame': 'Treatment Period 1, up to 24 weeks', 'description': 'Frequency of participants with injection site reactions in GP2015 and Enbrel'}, {'measure': 'Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients', 'timeFrame': 'baseline, week 2, week 4, week 12, week 24', 'description': 'Frequency of patients having anti-drug antibody (ADA) during 24 weeks (Treatment Period 1) using 1% false positive rate'}, {'measure': 'Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24;', 'timeFrame': 'week 4, 12, 24', 'description': 'DAS28-CRP is a disease activity score and defined in primary outcome measure. DAS28-ESR is the DAS28 erythrocyte sedimentation rate score.\n\nDAS28-CRP and DAS28-ESR:\n\n1. best is 0,\n2. \\< 2.6 - remission,\n3. ≥ 2.6 to ≤ 3.2 - low disease activity\n4. \\> 3.2 to ≤ 5.1 - moderate disease activity\n5. \\> 5.1 - high disease activity\n\nDAS28-ESR = 0.56 \\* sqrt(tender28) + 0.28\\* sqrt(swollen28) + 0.7 \\* ln(ESR) + 0.014 \\* GDA where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • ESR is erythrocyte sedimentation rate (mm/h) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm'}, {'measure': 'Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24', 'timeFrame': 'baseline, Week 4, week 12, week 24'}, {'measure': 'Treatment Period 1- Proportion of Patients Achieving EULAR Response', 'timeFrame': 'week 4, week 12 and week 24', 'description': 'Proportion of patients achieving European League against Rheumatism (EULAR) good response (defined as DAS28 ≤ 3.2 and DAS28 improvement from Baseline \\> 1.2) and moderate response (defined as DAS28 ≤ 3.2 and DAS28 improvement \\> 0.6 and ≤ 1.2, or DAS28 \\> 3.2 and ≤ 5.1 and DAS28 improvement \\> 0.6 or DAS28 \\> 5.1 but DAS28 improvement \\> 1.2) ;'}, {'measure': 'Treatment Period 1- Proportion of Patients Achieving DAS28 < 2.6 at Weeks 4, 12 and 24', 'timeFrame': 'week 4, week 12 and week 24', 'description': '% patients in DAS28-ESR categories up to week 24'}, {'measure': 'Treatment Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria', 'timeFrame': 'week 4, week 12, week 24', 'description': 'Proportion of patients achieving EULAR/American College of Rheumatology (EULAR/ACR) Boolean remission criteria (defined as number of tender joints/swollen joints ≤ 1 and CRP (mg/dL) ≤ 1 and patient global assessment (1-10) ≤ 1) at Weeks 4, 12 and 24;'}, {'measure': 'Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24;', 'timeFrame': 'Week 4, week 12 and week 24', 'description': 'ACR20 response was defined if a patient fulfilled all 3 criteria below:\n\n* 20% improvement in tender 68 joint-count\n* 20% improvement in swollen 68 joint-count;\n\nAnd 20% improvement in at least 3 of the following 5 measures:\n\n* Patient\'s assessment of RA pain (visual analogue scale (VAS) 100 mm),\n* Patient\'s global assessment of disease activity (VAS 100 mm),\n* Physician\'s global assessment of disease activity (VAS 100 mm),\n* Patient self-assessed disability (HAQ score),\n* Acute phase reactant (CRP or ESR). ACR50 and ACR70 responses were defined as ACR20 response replacing "20% improvement" by "50% improvement" and "70% improvement", respectively.'}, {'measure': 'Treatment Period 1- ACR-N Scores at Weeks 4, 12 and 24;', 'timeFrame': 'Weeks 4, 12 and 24;', 'description': 'ACR-N (American College of Rheumatology percentage of improvement): negative is worsening, positive (up to 100) is an improvement.\n\nACR-N is a single number that characterizes the percentage of improvement from Baseline that a patient has experienced in analogy to ACR20 described above. ACR-N of X (such as 38) means that the patient had achieved an improvement of at least X% (such as 38%) in tender and swollen joints, and an improvement of at least X% (such as 38%) in 3 of the 5 other parameters mentioned above.'}, {'measure': 'Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI', 'timeFrame': 'Weeks 4, 12 and 24;', 'description': "Proportion of patients in each disease activity category as defined by the Simplified Disease Activity Index (SDAI): high disease activity, SDAI \\> 26, moderate disease activity, SDAI \\> 11 to ≤ 26, low disease activity, SDAI \\> 3.3 to ≤ 11, and remission, SDAI ≤ 3.3 at Weeks 4, 12 and 24; SDAI and CDAI are measures of disease activity in RA. The scores were calculated by numerical summation of the number of tender and swollen joints (using the 28-joint count), and the patient's and physician's global assessment of disease activity."}, {'measure': 'Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI', 'timeFrame': 'Weeks 4, 12 and 24;', 'description': "Proportion of patients in each disease activity category as defined by the Clinical Disease Activity Index (CDAI): high disease activity, CDAI \\> 22, moderate disease activity, CDAI \\> 10 to ≤ 22, low disease activity, CDAI \\> 2.8 to ≤ 10, and remission, CDAI ≤ 2.8 at Weeks 4, 12 and 24; SDAI and CDAI are measures of disease activity in RA. The scores were calculated by numerical summation of the number of tender and swollen joints (using the 28-joint count), and the patient's and physician's global assessment of disease activity."}, {'measure': 'Treatment Period 1- Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 4, 12 and 24;', 'timeFrame': 'Weeks 4, 12 and 24;', 'description': 'Health assessment questionnaire (HAQ) disability index ranges from 0 (best) to 3 (worst)'}, {'measure': 'Treatment Period 1 - Health Assessment Questionnaire (HAQ) Index at Baseline, Weeks 4, 12 and 24;', 'timeFrame': 'Baseline, Weeks 4, 12 and 24;', 'description': 'Health assessment questionnaire (HAQ) disability index ranges from 0 (best) to 3 (worst)'}, {'measure': 'Treatment Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24;', 'timeFrame': 'Baseline, Weeks 4, 12 and 24;', 'description': 'FACIT fatigue scale is a 13- item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function, ranging from 0 (worst) to 52 (best). A score of less than 30 indicates severe fatigue.'}, {'measure': 'Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24', 'timeFrame': 'Weeks 4, 12 and 24'}, {'measure': 'Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24', 'timeFrame': 'Weeks 4, 12 and 24'}, {'measure': 'Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48;', 'timeFrame': 'Baseline, week 4, week 12, week 24, week 36 and week 48.', 'description': 'DAS28-CRP and DAS28-ESR:\n\n1. best is 0,\n2. \\< 2.6 - remission,\n3. ≥ 2.6 to ≤ 3.2 - low disease activity\n4. \\> 3.2 to ≤ 5.1 - moderate disease activity\n5. \\> 5.1 - high disease activity'}, {'measure': 'Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48', 'timeFrame': 'week 4, week 12, week 24, week 36, week 48'}, {'measure': 'Treatment Period 2: Proportion of Patients Achieving EULAR Reponse', 'timeFrame': 'week 4, week 12, week 24, week 36 and week 48', 'description': 'Proportion of patients achieving EULAR good response (defined as DAS28 ≤ 3.2 and DAS28 improvement from Baseline \\> 1.2) and moderate response (defined as DAS28 ≤ 3.2 and DAS28 improvement \\> 0.6 and ≤ 1.2, or DAS28 \\> 3.2 and ≤ 5.1 and DAS28 improvement \\> 0.6 or DAS28 \\> 5.1 but DAS28 improvement \\> 1.2) at Weeks 36 and 48;'}, {'measure': 'Treatment Period 2 : Proportion of Patients Achieving DAS28 < 2.6 at Weeks 36 and 48;', 'timeFrame': 'week 36 and week 48', 'description': 'percentage of participants in DAS28-ESR categories up to week 48'}, {'measure': 'Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria', 'timeFrame': 'week 4, week 12, week 24, week 36, week 48', 'description': 'Proportion of patients achieving EULAR/ACR Boolean remission criteria (defined as number of tender joints/swollen joints ≤ 1 and CRP (mg/dL) ≤ 1 and patient global assessment (1-10) ≤ 1) at Weeks 36 and 48;'}, {'measure': 'Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48;', 'timeFrame': 'week 36 and week 48'}, {'measure': 'Treatment Period 2 : ACR-N Scores at Weeks 36 and 48;', 'timeFrame': 'week 36 and week 48', 'description': 'ACR-N: negative is worsening, positive (up to 100) is an improvement'}, {'measure': 'Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI', 'timeFrame': 'baseline, week 4, week 12, week 24, week 36. week 48', 'description': 'Proportion of patients in each disease activity category as defined by the Simplified Disease Activity Index (SDAI): high disease activity, SDAI \\> 26, moderate disease activity, SDAI \\> 11 to ≤ 26, low disease activity, SDAI \\> 3.3 to ≤ 11, and remission, SDAI ≤ 3.3 at Weeks 36 and 48.'}, {'measure': 'Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI', 'timeFrame': 'baseline, week 4, week 12, week 24, week 36 and week 48', 'description': 'Proportion of patients in each disease activity category as defined by the Clinical Disease Activity Index (CDAI): high disease activity, CDAI \\> 22, moderate disease activity, CDAI \\> 10 to ≤ 22, low disease activity, CDAI \\> 2.8 to ≤ 10, and remission, CDAI ≤ 2.8 at Weeks 36 and 48;'}, {'measure': 'Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48;', 'timeFrame': 'baseline, week 4, week 12, week 24, week 36, week 48'}, {'measure': 'Treatment Period 2 :HAQ Index at Weeks 36 and 48;', 'timeFrame': 'baseline, week 4, week 12, week 24, week 36, week 48', 'description': 'HAQ: from 0 (best) to 3 (worst)'}, {'measure': 'Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48;', 'timeFrame': 'baseline, week 4, week 12, week 24, week 36, week 48', 'description': 'FACIT: from 0 (worst) to 52 (best), a score of less than 30 indicates severe fatigue'}, {'measure': 'Treatment Period 2 : CRP Levels at Week 36 and 48', 'timeFrame': 'baseline, week 4, week 12, week 24, week 36, week 48'}, {'measure': 'Treatment Period 2 : ESR Levels at Week 36 and 48', 'timeFrame': 'baseline, week 4, week 12, week 24, week 36, week 48'}, {'measure': 'Safety - Overall Study : Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel', 'timeFrame': 'up to 48 weeks', 'description': 'Frequency of participants with injection site reactions in GP2015 and Enbrel'}, {'measure': 'Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients', 'timeFrame': 'baseline, week 4, week 12, week 24, week 36, week 48', 'description': 'To assess the immunogenicity of continuous GP2015 treatment versus a treatment transition from Enbrel to GP2015 after 24 weeks of treatment by measuring the rate of ADA positive participants at Weeks 24, 30, 36 and 48. summary of ADA positive data up to week 48 using a 1% false positive cut point'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Biosimilars', 'Rheumatoid Arthritis', 'Etanercept'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '40279006', 'type': 'DERIVED', 'citation': 'Thaci D, Gerdes S, Schulze-Koops H, Allanore Y, Kavanaugh A, Both C, Gattu S, Hachaichi S, Matucci-Cerinic M. Patient-Reported Outcome Measures in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis Treated with GP2015, an Etanercept Biosimilar: Results from Two Phase III Studies (EGALITY and EQUIRA). Drugs R D. 2025 Jun;25(2):107-115. doi: 10.1007/s40268-025-00507-8. Epub 2025 Apr 25.'}, {'pmid': '31138316', 'type': 'DERIVED', 'citation': 'Jaworski J, Matucci-Cerinic M, Schulze-Koops H, Buch MH, Kucharz EJ, Allanore Y, Kavanaugh A, Young P, Babic G. Switch from reference etanercept to SDZ ETN, an etanercept biosimilar, does not impact efficacy, safety, and immunogenicity of etanercept in patients with moderate-to-severe rheumatoid arthritis: 48-week results from the phase III, randomized, double-blind EQUIRA study. Arthritis Res Ther. 2019 May 28;21(1):130. doi: 10.1186/s13075-019-1907-x.'}, {'pmid': '30487998', 'type': 'DERIVED', 'citation': 'Matucci-Cerinic M, Allanore Y, Kavanaugh A, Buch MH, Schulze-Koops H, Kucharz EJ, Woehling H, Babic G, Poetzl J, Davis A, Schwebig A. Efficacy, safety and immunogenicity of GP2015, an etanercept biosimilar, compared with the reference etanercept in patients with moderate-to-severe rheumatoid arthritis: 24-week results from the comparative phase III, randomised, double-blind EQUIRA study. RMD Open. 2018 Nov 14;4(2):e000757. doi: 10.1136/rmdopen-2018-000757. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX).', 'detailedDescription': 'Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX). In addition, data on the safety profiles of both products, including immunogenicity and local tolerability at the injection sites, will be collected and compared.\n\nAn additional study objective is to identify any potential risk of the transition from Enbrel to GP2015 in terms of general safety and immunogenicity in RA patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients at least 18 years of age with RA diagnosis according to ACR 1987 or ACR/EULAR 20110 criteria \\>/= 6 months at the time of baseline visit\n* Patient must have active disease defined as DAS28-CRP\\>/=3.2\n* Patients must have CRP level above ULN \\>5mg/l) or erythrocyte sedimentation rate (ESR) \\>/=28mm/h\n* Patients must have inadequate clinical response to MTX at a dose of 10-25 mg/wk after proper dose escalation according to local standards\n\nExclusion Criteria:\n\n* Previous exposure to etanercept in the past\n* Patients with functional status class IV according to the ACR 1991 revised criteria\n* History of active tuberculosis (TB) or Presence of latent (inactive)TB detected by imaging and/or by the QuantiFERON-TB Gold test at screening'}, 'identificationModule': {'nctId': 'NCT02638259', 'acronym': 'EQUIRA', 'briefTitle': 'Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sandoz'}, 'officialTitle': 'A Randomized, Double-blind, Parallel-group Phase III Study to Demonstrate Equivalent Efficacy and to Compare Safety & Immunogenicity of GP2015 and Enbrel® (EU Authorized) in Patients With Moderate to Severe, Active Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'GP15-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '50mg GP2015', 'description': 'Group 1 will receive treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continue treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).', 'interventionNames': ['Drug: GP2015']}, {'type': 'ACTIVE_COMPARATOR', 'label': '50mg EU-authorized Enbrel', 'description': 'Group 2 will receive treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response will be switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).', 'interventionNames': ['Drug: GP2015']}], 'interventions': [{'name': 'GP2015', 'type': 'DRUG', 'description': 'Enbrel comparator', 'armGroupLabels': ['50mg EU-authorized Enbrel', '50mg GP2015']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 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