Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-04-08 @ 9:35 AM
Study NCT ID:
NCT02640612
Status:
COMPLETED
Last Update Posted:
2018-12-05
First Post:
2015-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Assessment of Safety and Efficacy of BI 695501 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': 'C000632724', 'term': 'BI 695501'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first drug administration until 10 weeks after the last drug administration, up to 58 weeks.', 'description': 'An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. SAF was used for AE assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'BI 695501 to BI 695501', 'description': 'Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.', 'otherNumAtRisk': 225, 'deathsNumAtRisk': 225, 'otherNumAffected': 9, 'seriousNumAtRisk': 225, 'deathsNumAffected': 1, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Humira® to Humira®', 'description': 'Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.', 'otherNumAtRisk': 103, 'deathsNumAtRisk': 103, 'otherNumAffected': 6, 'seriousNumAtRisk': 103, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Humira® to BI 695501', 'description': 'Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 2, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}], 'seriousEvents': [{'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Incarcerated inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Bile duct stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Pyelonephritis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Benign soft tissue neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Henoch-Schonlein purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Drug-related Adverse Events (AEs) During the Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695501 to BI 695501', 'description': 'Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.'}, {'id': 'OG001', 'title': 'Humira® to Humira®', 'description': 'Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.'}, {'id': 'OG002', 'title': 'Humira® to BI 695501', 'description': 'Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '20.4', 'groupId': 'OG001'}, {'value': '17.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first drug administration until 10 weeks after the last drug administration, up to 58 weeks.', 'description': 'The analysis of AEs was based on the concept of treatment-emergent AEs (TEAEs). Thus, all AEs with an onset after the first dose of trial drug up to a period of ten weeks after the last dose of trial drug were assigned to the current treatment for evaluation. Investigator assessed drug related AEs were AEs with a relationship to drug ticked "yes" according to the Investigator.', 'unitOfMeasure': 'Percentage of patients (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAF): All patients who received at least 1 dose during trial 1297.3. In the event of doubt as to whether a patient was treated or not, they were assumed to have been treated for the purposes of analysis, and thus included in the SAF. Patients were classified according to randomized/re-randomized treatments of Trial 1297.2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score in 28 Joints (DAS 28) by Erythrocyte Sedimentation Rate (ESR) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695501 to BI 695501', 'description': 'Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.'}, {'id': 'OG001', 'title': 'Humira® to Humira®', 'description': 'Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.'}, {'id': 'OG002', 'title': 'Humira® to BI 695501', 'description': 'Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.01', 'spread': '1.385', 'groupId': 'OG000'}, {'value': '-2.91', 'spread': '1.323', 'groupId': 'OG001'}, {'value': '-2.98', 'spread': '1.218', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 48.', 'description': "The DAS28 (ESR) score was derived using the following formulae: DAS28 (ESR) = 0.56\\*√(TJC28) + 0.28\\*√(SJC28) + 0.014\\*(GH) + 0.7\\*ln(ESR) Where: • TJC28 = 28 joint count for tenderness • SJC28 = 28 joint count for swelling • GH = General Health component of the DAS (patient's global assessment of disease activity) • Ln (ESR) = natural logarithm of ESR. Last observation carried forward (LOCF) is the method used for handling missing components post baseline. Baseline for this trial was taken from the baseline of 1297.2. Improvement in DAS28 was also categorized using the European League Against Rheumatism (EULAR) response criteria. The DAS28 provides a number on a scale from 0 to 10 where higher values mean a higher disease activity. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.", 'unitOfMeasure': 'Unit on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FullAnalysisSet(FAS) includes patients from the all subjects assigned set who received at least 1 dose of trial drug in Trial 1297.3 and had at least 1 DAS28(ESR and C-reactive protein) or american college of rheumatology 20% response criteria (ACR20) measured during trial. Classified according to randomized/rerandomized treatments of trial 1297.2.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Meeting American College of Rheumatology (ACR) 20% Response Criteria at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695501 to BI 695501', 'description': 'Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.'}, {'id': 'OG001', 'title': 'Humira® to Humira®', 'description': 'Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.'}, {'id': 'OG002', 'title': 'Humira® to BI 695501', 'description': 'Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000'}, {'value': '76.7', 'groupId': 'OG001'}, {'value': '73.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48.', 'description': "The proportion of patients meeting the ACR20 response criteria was assessed. A patient had an ACR20 response if all of the following occurred: A ≥ 20 % improvement in the swollen joint count (66 joints), A ≥ 20 % improvement in the tender joint count (68 joints), A ≥ 20 % improvement in at least three of the following assessments: Patient's assessment of pain, Patient's global assessment of disease activity (equivalent to the General Health component of the Disease Activity Score (\\[DAS\\]), Physician's global assessment of disease activity, Patient's assessment of physical function, as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) Acute phase reactant (C-reactive protein \\[CRP\\]).", 'unitOfMeasure': 'Percentage of patients (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, All patients who discontinue treatment, are lost-to-follow-up or have any severe violation related to any therapy that may significantly impact efficacy assessment prior to the secondary endpoint assessment will be considered as a non-responder (NRI).'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Meet the American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) Definition of Remission at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695501 to BI 695501', 'description': 'Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.'}, {'id': 'OG001', 'title': 'Humira® to Humira®', 'description': 'Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.'}, {'id': 'OG002', 'title': 'Humira® to BI 695501', 'description': 'Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000'}, {'value': '9.7', 'groupId': 'OG001'}, {'value': '6.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48.', 'description': 'The ACR/EULAR remission criteria were based on a Boolean definition. At any time point, the patient must have satisfied all of the following:\n\n* Tender joint count (TJC) ≤ 1\n* Swollen joint count (SJC) ≤ 1\n* C-reactive protein (CRP) ≤ 1 mg/dL\n* Patient global assessment of disease activity ≤ 10 (on a 0 to 100 scale) For TJC and SJC, use of a 28-joint count may have missed actively involved joints, particularly in the feet and ankles. It was preferable to include the feet and ankles when evaluating remission.', 'unitOfMeasure': 'Percentage of patients (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With European League Against Rheumatism (EULAR) Response (Good Response, Moderate Response, or no Response) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695501 to BI 695501', 'description': 'Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.'}, {'id': 'OG001', 'title': 'Humira® to Humira®', 'description': 'Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.'}, {'id': 'OG002', 'title': 'Humira® to BI 695501', 'description': 'Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.'}], 'classes': [{'title': 'Good Response', 'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000'}, {'value': '37.9', 'groupId': 'OG001'}, {'value': '41.6', 'groupId': 'OG002'}]}]}, {'title': 'Moderate Response', 'categories': [{'measurements': [{'value': '49.8', 'groupId': 'OG000'}, {'value': '54.4', 'groupId': 'OG001'}, {'value': '51.5', 'groupId': 'OG002'}]}]}, {'title': 'No Response', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}, {'value': '5.8', 'groupId': 'OG001'}, {'value': '3.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48.', 'description': 'Percentage of patients with European League Against Rheumatism (EULAR) response (good response, moderate response, or no response) were calculated at Week 48 for assessment of this outcome measure.\n\nNo response: If improvement in DAS28 (ESR) at w48 \\<=0.6, or if DAS28(ESR) at w48 \\>5.1 and improvement is in range \\>0.6 to \\<1.2.\n\nModerate response: If DAS28(ESR) at w48 \\<=5.1 and improvement is in range \\>0.6 to \\<1.2, or, DAS28(ESR) at w48 \\>3.2 and improvement is in range \\>=1.2.\n\nGood response: If DAS28(ESR) at w48 \\<=3.2 and improvement \\>=1.2.', 'unitOfMeasure': 'Percentage of patients (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BI 695501 to BI 695501', 'description': 'Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.'}, {'id': 'FG001', 'title': 'Humira® to Humira®', 'description': 'Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.'}, {'id': 'FG002', 'title': 'Humira® to BI 695501', 'description': 'Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '225'}, {'groupId': 'FG001', 'numSubjects': '103'}, {'groupId': 'FG002', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '96'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "This study was an open-label extension trial. Adult patients with moderate to severely active rheumatoid arthritis (RA) who completed Trial NCT02137226 (1297.2), wished to participate in this extension trial and per Investigator's assessment could benefit from continuing to receive BI 695501 were included in this trial.", 'preAssignmentDetails': 'All patients were screened for eligibility to participate in the trial. The screening visit of this trial was the Week 48 visit in Trial 1297.2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '430', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'BI 695501 to BI 695501', 'description': 'Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.'}, {'id': 'BG001', 'title': 'Humira® to Humira®', 'description': 'Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.'}, {'id': 'BG002', 'title': 'Humira® to BI 695501', 'description': 'Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'spread': '11.87', 'groupId': 'BG000'}, {'value': '51.7', 'spread': '11.21', 'groupId': 'BG001'}, {'value': '54.6', 'spread': '9.90', 'groupId': 'BG002'}, {'value': '53.5', 'spread': '11.30', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Age of all patients included in the trial', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'SAF'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '360', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gender distribution of all patients included in the trial.', 'unitOfMeasure': 'Participants', 'populationDescription': 'SAF'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '385', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Ethnicity of all patients included in the trial', 'unitOfMeasure': 'Participants', 'populationDescription': 'SAF'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '215', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '415', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race of all patients included in the trial', 'unitOfMeasure': 'Participants', 'populationDescription': 'SAF'}], 'populationDescription': 'Safety Analysis Set (SAF): All patients who received at least 1 dose during trial 1297.3. In the event of doubt as to whether a patient was treated or not, they were assumed to have been treated for the purposes of analysis, and thus included in the SAF. Patients were classified according to randomized/re-randomized treatments of Trial 1297.2.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-19', 'size': 1061724, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-10-22T00:27', 'hasProtocol': True}, {'date': '2016-06-22', 'size': 821062, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-10-22T00:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 430}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-03', 'studyFirstSubmitDate': '2015-12-18', 'resultsFirstSubmitDate': '2018-10-22', 'studyFirstSubmitQcDate': '2015-12-23', 'lastUpdatePostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-03', 'studyFirstPostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Drug-related Adverse Events (AEs) During the Treatment Phase', 'timeFrame': 'From the first drug administration until 10 weeks after the last drug administration, up to 58 weeks.', 'description': 'The analysis of AEs was based on the concept of treatment-emergent AEs (TEAEs). Thus, all AEs with an onset after the first dose of trial drug up to a period of ten weeks after the last dose of trial drug were assigned to the current treatment for evaluation. Investigator assessed drug related AEs were AEs with a relationship to drug ticked "yes" according to the Investigator.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Disease Activity Score in 28 Joints (DAS 28) by Erythrocyte Sedimentation Rate (ESR) at Week 48', 'timeFrame': 'Baseline and Week 48.', 'description': "The DAS28 (ESR) score was derived using the following formulae: DAS28 (ESR) = 0.56\\*√(TJC28) + 0.28\\*√(SJC28) + 0.014\\*(GH) + 0.7\\*ln(ESR) Where: • TJC28 = 28 joint count for tenderness • SJC28 = 28 joint count for swelling • GH = General Health component of the DAS (patient's global assessment of disease activity) • Ln (ESR) = natural logarithm of ESR. Last observation carried forward (LOCF) is the method used for handling missing components post baseline. Baseline for this trial was taken from the baseline of 1297.2. Improvement in DAS28 was also categorized using the European League Against Rheumatism (EULAR) response criteria. The DAS28 provides a number on a scale from 0 to 10 where higher values mean a higher disease activity. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6."}, {'measure': 'Percentage of Patients Meeting American College of Rheumatology (ACR) 20% Response Criteria at Week 48', 'timeFrame': 'Week 48.', 'description': "The proportion of patients meeting the ACR20 response criteria was assessed. A patient had an ACR20 response if all of the following occurred: A ≥ 20 % improvement in the swollen joint count (66 joints), A ≥ 20 % improvement in the tender joint count (68 joints), A ≥ 20 % improvement in at least three of the following assessments: Patient's assessment of pain, Patient's global assessment of disease activity (equivalent to the General Health component of the Disease Activity Score (\\[DAS\\]), Physician's global assessment of disease activity, Patient's assessment of physical function, as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) Acute phase reactant (C-reactive protein \\[CRP\\])."}, {'measure': 'Percentage of Patients Who Meet the American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) Definition of Remission at Week 48', 'timeFrame': 'Week 48.', 'description': 'The ACR/EULAR remission criteria were based on a Boolean definition. At any time point, the patient must have satisfied all of the following:\n\n* Tender joint count (TJC) ≤ 1\n* Swollen joint count (SJC) ≤ 1\n* C-reactive protein (CRP) ≤ 1 mg/dL\n* Patient global assessment of disease activity ≤ 10 (on a 0 to 100 scale) For TJC and SJC, use of a 28-joint count may have missed actively involved joints, particularly in the feet and ankles. It was preferable to include the feet and ankles when evaluating remission.'}, {'measure': 'Percentage of Patients With European League Against Rheumatism (EULAR) Response (Good Response, Moderate Response, or no Response) at Week 48', 'timeFrame': 'Week 48.', 'description': 'Percentage of patients with European League Against Rheumatism (EULAR) response (good response, moderate response, or no response) were calculated at Week 48 for assessment of this outcome measure.\n\nNo response: If improvement in DAS28 (ESR) at w48 \\<=0.6, or if DAS28(ESR) at w48 \\>5.1 and improvement is in range \\>0.6 to \\<1.2.\n\nModerate response: If DAS28(ESR) at w48 \\<=5.1 and improvement is in range \\>0.6 to \\<1.2, or, DAS28(ESR) at w48 \\>3.2 and improvement is in range \\>=1.2.\n\nGood response: If DAS28(ESR) at w48 \\<=3.2 and improvement \\>=1.2.'}]}, 'conditionsModule': {'conditions': ['Arthritis, Rheumatoid']}, 'referencesModule': {'references': [{'pmid': '33263165', 'type': 'DERIVED', 'citation': 'Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.'}, {'pmid': '32363771', 'type': 'DERIVED', 'citation': 'Kang J, Eudy-Byrne RJ, Mondick J, Knebel W, Jayadeva G, Liesenfeld KH. Population pharmacokinetics of adalimumab biosimilar adalimumab-adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity. Br J Clin Pharmacol. 2020 Nov;86(11):2274-2285. doi: 10.1111/bcp.14330. Epub 2020 Jun 11.'}, {'pmid': '31387417', 'type': 'DERIVED', 'citation': 'Cohen SB, Czeloth N, Lee E, Klimiuk PA, Peter N, Jayadeva G. Long-term safety, efficacy, and immunogenicity of adalimumab biosimilar BI 695501 and adalimumab reference product in patients with moderately-to-severely active rheumatoid arthritis: results from a phase 3b extension study (VOLTAIRE-RAext). Expert Opin Biol Ther. 2019 Oct;19(10):1097-1105. doi: 10.1080/14712598.2019.1645114. Epub 2019 Aug 6.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this trial is to provide long-term safety, pharmacokinetics (PK), and immunogenicity data on BI 695501 administered via prefilled syringe in patients with Rheumatoid Arthritis who have completed Trial 1297.2. The primary endpoint thereby is the number (proportion) of patients with drug-related adverse events (AEs) during the treatment phase. The secondary objective in this trial is the assessment of Long-term efficacy of BI 695501 by evaluation of:\n\n* the change from Baseline in DAS28 (ESR) at Week 48\n* the proportion of patients meeting American College of Rheumatology 20% (ACR20) response criteria at Week 48\n* the proportion of patients who meet the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) definition of remission at Week 48\n* the proportion of patients with EULAR response (good response, moderate response, or no response) at Week 48.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* All patients must sign and date an Informed Consent Form consistent withInternational Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and local legislation prior to participation in the trial (i.e., prior to any trial procedures, which include medication washout and restrictions) and be willing to follow the protocol.\n* Adult patients with moderately to severely active RA who have completed Trial 1297.2, and who wish to participate in this extension trial and in the investigator´s assessment can benefit from receiving BI 695501.\n* Patients willing and able to self-administer BI 695501 pre-filled syringe.\n* Willing to use a reliable means of contraception throughout trial participation (females) and willing to use an acceptable method of contraception for 6 months following completion or discontinuation from the trial medication males and females).\n\nExclusion criteria:\n\n* Investigator-reported drug-related Serious Adverse Events (SAEs) in Trial 1297.2\n* ACR functional Class IV or wheelchair/bed bound\n* Primary or secondary immunodeficiency (history of, or currently active)\n* Positive QuantiFERON test\n* Known clinically significant coronary artery disease or significant cardiac arrhythmias or severe congestive heart failure (NYHA Classes III / IV), or interstitial lung disease\n* Anaphylactic reaction or hypersensitivity to adalimumab in Trial 1297.2\n* History / recent evidence of cancer incl. solid tumours, hematologic malignancies, and carcinoma in situ (certain exceptions permitted)\n* Positive serology for Hepatitis B virus (HBV) or Hepatitis C virus (HCV)\n* Planned live virus or bacterial vaccinations during the trial, or up to 3 months after the last dose of trial drug\n* Receipt or treatment (including biologic therapies) that may place the patient at unacceptable risk during the trial\n* Significant disease (disease which may (i) put the patient at risk because of participation or (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial) other than RA and/or a significant uncontrolled disease\n* Women: premenopausal (last menstruation 1 year prior to screening), sexually active, pregnant or nursing, or of child-bearing potential and not practicing an acceptable method of birth control, or not planning to use an acceptable method of birth control throughout the trial\n* Current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, etc.) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, pulmonary fibrosis, etc.). Secondary Sjögren´s syndrome or secondary limited cutaneous vasculitis with RA is permitted\n* Any planned surgical procedure, including bone/joint surgery/synovectomy for the duration of the trial\n* Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with iv. anti-infectives within 4 weeks of the Screening Visit or completion of oral anti-infectives within 2 weeks of the Screening Visit\n* Serious infection or opportunistic infection during the 1297.2 trial\n* Any acquired neurological, vascular, systemic or demyelinating disorder that might affect any of the efficacy assessments, in particular, joint pain and swelling (e.g., Parkinson´s disease, cerebral palsy, diabetic neuropathy) that occurred during the 1297.2 trial.\n* Currently active alcohol or drug abuse\n* Treatment with iv. Gamma Globulin or the Prosorba® Column during the 1297.2 trial\n* Planned treatment with iv. intramuscular, intra-articular and parenteral corticosteroids\n* Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\>1.5 times upper limit of normal (ULN)\n* Hemoglobin \\<8.0 g/dL\n* Platelets \\<100,000/µL\n* Leukocyte count \\<4000/µL\n* Creatine clearance \\<60 mL/min\n* Current participation in another clinical trial"}, 'identificationModule': {'nctId': 'NCT02640612', 'briefTitle': 'Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Long-term Assessment of Safety, Efficacy, Pharmacokinetics and Immunogenicity of BI 695501 in Patients With Rheumatoid Arthritis (RA): an Open-label Extension Trial for Patients Who Have Completed Trial 1297.2 and Are Eligible for Long-term Treatment With Adalimumab', 'orgStudyIdInfo': {'id': '1297.3'}, 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