Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-28 @ 9:12 AM
Study NCT ID:
NCT03649061
Status:
COMPLETED
Last Update Posted:
2025-06-19
First Post:
2018-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'patrick.verschueren@uzleuven.be', 'phone': '+3216342541', 'title': 'Prof. Dr. Patrick Verschueren', 'organization': 'UZLeuven'}, 'certainAgreement': {'otherDetails': "Institution/PI may only publish the Results provided that Sponsor has duly published the main Study publication. Once the main Study publication has been duly published by the Sponsor, Institution/PI are entitled to publish the Results provided that Sponsor has granted its prior written approval with Institution's/PI's proposed publication. If SPONSOR did not respond within 90 days, the institution/PI may proceed with the publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '(Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)', 'description': 'In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard COBRA-Slim Induction', 'description': 'Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nLeflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 43, 'seriousNumAtRisk': 55, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'COBRA-Slim Bio-induction', 'description': 'Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nEtanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 47, 'seriousNumAtRisk': 55, 'deathsNumAffected': 1, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'seriousEvents': [{'term': 'aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'cerobrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'psychiatric decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'enterococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under Curve (AUC) of Disease Activity Score Based on a 28 Jointcount and C-reactive Protein (DAS28CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard COBRA-Slim Induction', 'description': 'Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nLeflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme'}, {'id': 'OG001', 'title': 'COBRA-Slim Bio-induction', 'description': 'Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nEtanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme'}], 'classes': [{'categories': [{'measurements': [{'value': '297.4', 'groupId': 'OG000', 'lowerLimit': '277.1', 'upperLimit': '317.7'}, {'value': '300.7', 'groupId': 'OG001', 'lowerLimit': '282.3', 'upperLimit': '319.1'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'To compare the two randomization groups, a linear mixed model with DAS28-CRP as outcome (Bell et al. 2014), including random intercepts per patient, adjusted for baseline DAS28-CRP, randomization timepoint, and RF and/or ACPA seropositivity was used.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, w4, w8, w16, w24, w32, w40, w52, w64, w78, w92 and w104', 'description': 'Analysis was based on an intention to treat population, which focused on all patients randomized into the study, irrespective if they actually received the randomized treatment. Fifty-five patients were allocated to Standard COBRA-Slim and 55 to COBRA-Slim Bio-induction.\n\nThis measure is an indication of the total disease-activity over time or long-term effectiveness, a higher area under the curve indicates a higher disease activity over time and so a lower effectiveness over the time frame of the trial.\n\nThe scale range for the duration of the trial (104 weeks) is 0.0 to 977.6\n\n* remission: value below 270.4\n* low disease activity: from 270.4 till 332.8 (included)\n* moderate disease activity: above 332.8 till 530.4\n* high disease activity: above 530.4', 'unitOfMeasure': 'units on a scale*week', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Proportion of Insufficient Responders Achieving Remission (DAS28CRP<2.6) 28 Weeks After Randomization (Short Term Efficacy) to Either COBRA-Slim Bio-Induction or Standard COBRA-Slim Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard COBRA-Slim Induction', 'description': 'Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nLeflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme'}, {'id': 'OG001', 'title': 'COBRA-Slim Bio-induction', 'description': 'Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nEtanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '32'}, {'value': '32', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '40'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A binomial generalized linear mixed effect model for repeated measures of remission from randomization up until 28 weeks after was carried out, with adjustment for baseline DAS28-CRP, moment of randomization, and RF and/or ACPA seropositivity.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization till 28 weeks after randomization.', 'description': 'Short-time efficacy of disease activity based on a swollen and tender joint count of 28 joints and C-reactive proteine (scale range 0.0 to 9.4; remission: value below 2.6; low disease activity: from 2.6 till 3.2 (included); moderate disease activity: above 3.2 till 5.1; high disease activity: above 5.1).', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients in Remission Defined as DAS28CRP<2.6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard COBRA-Slim Induction', 'description': 'Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nLeflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme'}, {'id': 'OG001', 'title': 'COBRA-Slim Bio-induction', 'description': 'Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nEtanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '44'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '37'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at week 104', 'description': 'Short-time efficacy of disease activity based on a swollen and tender joint count of 28 joints and C-reactive proteine (scale range 0.0 to 9.4; remission: value below 2.6; low disease activity: from 2.6 till 3.2 (included); moderate disease activity: above 3.2 till 5.1; high disease activity: above 5.1).', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Achieving a EULAR Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard COBRA-Slim Induction', 'description': 'Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nLeflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme'}, {'id': 'OG001', 'title': 'COBRA-Slim Bio-induction', 'description': 'Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nEtanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme'}], 'classes': [{'title': 'Good Response', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '34'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '33'}]}]}, {'title': 'Moderate Response', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '47'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '46'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 28 weeks after randomization', 'description': 'proportion of patients achieving a EULAR response, based on actual disease activity on a tender/swollen joint count and C-reactive proteine (DAS28-CRP) 28 weeks after randomization and improvement in DAS28-CRP from baseline.\n\nThe EULAR response criteria classify patients as good, moderate or non-responders, using the individual amount of change in the DAS28-CRP and the DAS28-CRP value (low, moderate, or high) reached according to the following tabel:\n\nDAS28-CRP at endpoint improvement in DAS28-CRP from baseline \\<=1,2 \\>0,6 and \\<= 1,2 \\<=0,6 \\<= 3,2 good moderate none \\>3,2 and \\<= 5,1 moderate moderate none \\>5,1 moderate none none Additionally all patients with a good response were also included in the number of participants with at least a moderate response.', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Achieving a EULAR Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard COBRA-Slim Induction', 'description': 'Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nLeflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme'}, {'id': 'OG001', 'title': 'COBRA-Slim Bio-induction', 'description': 'Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nEtanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme'}], 'classes': [{'title': 'Good Response', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '48'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '41'}]}]}, {'title': 'Moderate Response', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '54'}, {'value': '49', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '52'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at week 104', 'description': 'proportion of patients achieving a EULAR response, based on actual disease activity on a tender/swollen joint count and C-reactive proteine (DAS28-CRP) at week 104 and improvement in DAS28-CRP from baseline.\n\nThe EULAR response criteria classify patients as good, moderate or non-responders, using the individual amount of change in the DAS28-CRP and the DAS28-CRP value (low, moderate, or high) reached according to the following tabel:\n\nDAS28-CRP at endpoint improvement in DAS28-CRP from baseline \\<=1,2 \\>0,6 and \\<= 1,2 \\<=0,6 \\<= 3,2 good moderate none \\>3,2 and \\<= 5,1 moderate moderate none \\>5,1 moderate none none Additionally all patients with a good response were also included in the number of participants with at least a moderate response.', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire (HAQ) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard COBRA-Slim Induction', 'description': 'Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nLeflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme'}, {'id': 'OG001', 'title': 'COBRA-Slim Bio-induction', 'description': 'Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nEtanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 28 weeks after randomization', 'description': 'HAQ measures physical function as reported by the patient, total score range from 0-3 of which higher scores represent worse physical function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire (HAQ) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard COBRA-Slim Induction', 'description': 'Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nLeflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme'}, {'id': 'OG001', 'title': 'COBRA-Slim Bio-induction', 'description': 'Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nEtanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at week 104', 'description': 'HAQ measures physical function as reported by the patient, total score range from 0-3 of which higher scores represent worse physical function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Radiographic Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard COBRA-Slim Induction', 'description': 'Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nLeflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme'}, {'id': 'OG001', 'title': 'COBRA-Slim Bio-induction', 'description': 'Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nEtanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at week 52', 'description': 'Radiographic progression at week 52 is scored according to the Sharp-Van der Heijde score (SvdH).\n\nThe SvdH method scores the presence of erosions in 16 joints of hands and wrists (graded from 0 to 5), and in 6 joints of the feet (graded from 0 to 10), and the presence of joint space narrowing in 15 joints of the hands and wrists (graded from 0 to 4) and in 6 joints of the feet (graded from 0 to 4). The maximal range is 280 units for erosion and 168 units for joint space narrowing, summing up to 448 units for the total score.\n\nThe progression is calculated by subtracting the total score at week 52 minus the total score at baseline (ranging from 0 to 448) Higher values in each (sub) scale represents a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Radiographic Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard COBRA-Slim Induction', 'description': 'Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nLeflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme'}, {'id': 'OG001', 'title': 'COBRA-Slim Bio-induction', 'description': 'Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nEtanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at week 104', 'description': 'Radiographic progression at week 104 is scored according to the Sharp-Van der Heijde score (SvdH).\n\nThe SvdH method scores the presence of erosions in 16 joints of hands and wrists (graded from 0 to 5), and in 6 joints of the feet (graded from 0 to 10), and the presence of joint space narrowing in 15 joints of the hands and wrists (graded from 0 to 4) and in 6 joints of the feet (graded from 0 to 4). The maximal range is 280 units for erosion and 168 units for joint space narrowing, summing up to 448 units for the total score.\n\nThe progression is calculated by subtracting the total score at week 104 minus the total score at baseline (ranging from 0 to 448) Higher values in each (sub) scale represents a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard COBRA-Slim Induction', 'description': 'Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nLeflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme'}, {'id': 'FG001', 'title': 'COBRA-Slim Bio-induction', 'description': 'Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nEtanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Of the 284 patients screened, 276 were eligible for the trial and 122 met the criteria of early insufficient responders to an initial COBRA-Slim remission induction regimen. Of this last group 112 patients were randomized, however 2 were considered randomization errors, 10 patients were eligible for randomization but were not randomized per investigator decision.', 'preAssignmentDetails': 'All patients received a COBRA-Slim remission induction regimen, consisting of methotrexate (MTX) with a step-down scheme of glucocorticosteroids (GC).\n\nPatient not reaching low disease activity, based on DAS28CRP, before week 32 or DAS28CRP remission at week 32 were considered early insufficient responders and were eligible for randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard COBRA-Slim Induction', 'description': 'Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nLeflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme'}, {'id': 'BG001', 'title': 'COBRA-Slim Bio-induction', 'description': 'Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)\n\nEtanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53.4', 'spread': '13.1', 'groupId': 'BG000'}, {'value': '52.5', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '52.9', 'spread': '13.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'smoking', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'categories': [{'title': 'never', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'past', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'current', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Rheumatoid factor (RF)/Anti-citrullinated protein antibodies (ACPA ) status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'categories': [{'title': 'positive', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'negative', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Disease activity (DAS28CRP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '5.2', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '5.3', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Disease activity score based on a 28 joint count (Tender and Swollen joints) and C-Reactive Proteine (CRP) value.\n\nScale range 0.0 to 9.4.\n\nScale interpretation:\n\n* Remission: value below 2.6\n* Low disease activity: from 2.6 till 3.2 (included)\n* Moderate disease activity: above 3.2 till 5.1\n* High disease activity: above 5.1', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Disease duration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'BG000', 'lowerLimit': '2.5', 'upperLimit': '20.0'}, {'value': '7.0', 'groupId': 'BG001', 'lowerLimit': '2.5', 'upperLimit': '19.5'}, {'value': '7.0', 'groupId': 'BG002', 'lowerLimit': '2.3', 'upperLimit': '19.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-29', 'size': 1090373, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-03T07:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Insufficient responders to a COBRA-Slim strategy, defined as not reaching low disease activity based on DAS28 CRP from week 8 until week 32 or not reaching remission based on DAS28 CRP at week 32, will be randomly assigned to one of the two arms.\n\nRandomization will be balanced according to time-point of randomization, baseline (BL) disease activity and Anti-Citrullinated Protein Antibody (ACPA) and Rheumatoid Factor (RF) status to ensure comparability of the treatment groups with respect to these prognostic variables.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 276}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2018-07-30', 'resultsFirstSubmitDate': '2023-08-03', 'studyFirstSubmitQcDate': '2018-08-23', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-04', 'studyFirstPostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under Curve (AUC) of Disease Activity Score Based on a 28 Jointcount and C-reactive Protein (DAS28CRP)', 'timeFrame': 'baseline, w4, w8, w16, w24, w32, w40, w52, w64, w78, w92 and w104', 'description': 'Analysis was based on an intention to treat population, which focused on all patients randomized into the study, irrespective if they actually received the randomized treatment. Fifty-five patients were allocated to Standard COBRA-Slim and 55 to COBRA-Slim Bio-induction.\n\nThis measure is an indication of the total disease-activity over time or long-term effectiveness, a higher area under the curve indicates a higher disease activity over time and so a lower effectiveness over the time frame of the trial.\n\nThe scale range for the duration of the trial (104 weeks) is 0.0 to 977.6\n\n* remission: value below 270.4\n* low disease activity: from 270.4 till 332.8 (included)\n* moderate disease activity: above 332.8 till 530.4\n* high disease activity: above 530.4'}], 'secondaryOutcomes': [{'measure': 'Proportion of Insufficient Responders Achieving Remission (DAS28CRP<2.6) 28 Weeks After Randomization (Short Term Efficacy) to Either COBRA-Slim Bio-Induction or Standard COBRA-Slim Induction', 'timeFrame': 'From randomization till 28 weeks after randomization.', 'description': 'Short-time efficacy of disease activity based on a swollen and tender joint count of 28 joints and C-reactive proteine (scale range 0.0 to 9.4; remission: value below 2.6; low disease activity: from 2.6 till 3.2 (included); moderate disease activity: above 3.2 till 5.1; high disease activity: above 5.1).'}, {'measure': 'Proportion of Patients in Remission Defined as DAS28CRP<2.6', 'timeFrame': 'at week 104', 'description': 'Short-time efficacy of disease activity based on a swollen and tender joint count of 28 joints and C-reactive proteine (scale range 0.0 to 9.4; remission: value below 2.6; low disease activity: from 2.6 till 3.2 (included); moderate disease activity: above 3.2 till 5.1; high disease activity: above 5.1).'}, {'measure': 'Proportion of Patients Achieving a EULAR Response', 'timeFrame': 'at 28 weeks after randomization', 'description': 'proportion of patients achieving a EULAR response, based on actual disease activity on a tender/swollen joint count and C-reactive proteine (DAS28-CRP) 28 weeks after randomization and improvement in DAS28-CRP from baseline.\n\nThe EULAR response criteria classify patients as good, moderate or non-responders, using the individual amount of change in the DAS28-CRP and the DAS28-CRP value (low, moderate, or high) reached according to the following tabel:\n\nDAS28-CRP at endpoint improvement in DAS28-CRP from baseline \\<=1,2 \\>0,6 and \\<= 1,2 \\<=0,6 \\<= 3,2 good moderate none \\>3,2 and \\<= 5,1 moderate moderate none \\>5,1 moderate none none Additionally all patients with a good response were also included in the number of participants with at least a moderate response.'}, {'measure': 'Proportion of Patients Achieving a EULAR Response', 'timeFrame': 'at week 104', 'description': 'proportion of patients achieving a EULAR response, based on actual disease activity on a tender/swollen joint count and C-reactive proteine (DAS28-CRP) at week 104 and improvement in DAS28-CRP from baseline.\n\nThe EULAR response criteria classify patients as good, moderate or non-responders, using the individual amount of change in the DAS28-CRP and the DAS28-CRP value (low, moderate, or high) reached according to the following tabel:\n\nDAS28-CRP at endpoint improvement in DAS28-CRP from baseline \\<=1,2 \\>0,6 and \\<= 1,2 \\<=0,6 \\<= 3,2 good moderate none \\>3,2 and \\<= 5,1 moderate moderate none \\>5,1 moderate none none Additionally all patients with a good response were also included in the number of participants with at least a moderate response.'}, {'measure': 'Health Assessment Questionnaire (HAQ) Response', 'timeFrame': 'at 28 weeks after randomization', 'description': 'HAQ measures physical function as reported by the patient, total score range from 0-3 of which higher scores represent worse physical function.'}, {'measure': 'Health Assessment Questionnaire (HAQ) Response', 'timeFrame': 'at week 104', 'description': 'HAQ measures physical function as reported by the patient, total score range from 0-3 of which higher scores represent worse physical function.'}, {'measure': 'Radiographic Progression', 'timeFrame': 'at week 52', 'description': 'Radiographic progression at week 52 is scored according to the Sharp-Van der Heijde score (SvdH).\n\nThe SvdH method scores the presence of erosions in 16 joints of hands and wrists (graded from 0 to 5), and in 6 joints of the feet (graded from 0 to 10), and the presence of joint space narrowing in 15 joints of the hands and wrists (graded from 0 to 4) and in 6 joints of the feet (graded from 0 to 4). The maximal range is 280 units for erosion and 168 units for joint space narrowing, summing up to 448 units for the total score.\n\nThe progression is calculated by subtracting the total score at week 52 minus the total score at baseline (ranging from 0 to 448) Higher values in each (sub) scale represents a worse outcome.'}, {'measure': 'Radiographic Progression', 'timeFrame': 'at week 104', 'description': 'Radiographic progression at week 104 is scored according to the Sharp-Van der Heijde score (SvdH).\n\nThe SvdH method scores the presence of erosions in 16 joints of hands and wrists (graded from 0 to 5), and in 6 joints of the feet (graded from 0 to 10), and the presence of joint space narrowing in 15 joints of the hands and wrists (graded from 0 to 4) and in 6 joints of the feet (graded from 0 to 4). The maximal range is 280 units for erosion and 168 units for joint space narrowing, summing up to 448 units for the total score.\n\nThe progression is calculated by subtracting the total score at week 104 minus the total score at baseline (ranging from 0 to 448) Higher values in each (sub) scale represents a worse outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COBRA-Slim', 'Accelerated access to anti-TNF', 'treat to target', 'remission induction'], 'conditions': ['Arthritis, Rheumatoid']}, 'referencesModule': {'references': [{'pmid': '26399601', 'type': 'BACKGROUND', 'citation': 'Van der Elst K, De Cock D, Vecoven E, Arat S, Meyfroidt S, Joly J, Moons P, Verschueren P, Westhovens R, CareRA Study Group. Are illness perception and coping style associated with the delay between symptom onset and the first general practitioner consultation in early rheumatoid arthritis management? An exploratory study within the CareRA trial. Scand J Rheumatol. 2016;45(3):171-8. doi: 10.3109/03009742.2015.1074278. Epub 2015 Sep 23.'}, {'pmid': '19169906', 'type': 'BACKGROUND', 'citation': 'Verschueren P, Esselens G, Westhovens R. Predictors of remission, normalized physical function, and changes in the working situation during follow-up of patients with early rheumatoid arthritis: an observational study. Scand J Rheumatol. 2009 May-Jun;38(3):166-72. doi: 10.1080/03009740802484846.'}, {'pmid': '28968687', 'type': 'RESULT', 'citation': 'Verschueren P, Westhovens R. The use of glucocorticoids in early rheumatoid arthritis. Rheumatology (Oxford). 2018 Aug 1;57(8):1316-1317. doi: 10.1093/rheumatology/kex271. No abstract available.'}, {'pmid': '27432356', 'type': 'RESULT', 'citation': 'Verschueren P, De Cock D, Corluy L, Joos R, Langenaken C, Taelman V, Raeman F, Ravelingien I, Vandevyvere K, Lenaerts J, Geens E, Geusens P, Vanhoof J, Durnez A, Remans J, Vander Cruyssen B, Van Essche E, Sileghem A, De Brabanter G, Joly J, Meyfroidt S, Van der Elst K, Westhovens R. Effectiveness of methotrexate with step-down glucocorticoid remission induction (COBRA Slim) versus other intensive treatment strategies for early rheumatoid arthritis in a treat-to-target approach: 1-year results of CareRA, a randomised pragmatic open-label superiority trial. Ann Rheum Dis. 2017 Mar;76(3):511-520. doi: 10.1136/annrheumdis-2016-209212. Epub 2016 Jul 18.'}, {'pmid': '26058860', 'type': 'RESULT', 'citation': 'De Cock D, Van der Elst K, Meyfroidt S, Verschueren P, Westhovens R. The optimal combination therapy for the treatment of early rheumatoid arthritis. Expert Opin Pharmacother. 2015;16(11):1615-25. doi: 10.1517/14656566.2015.1056735. Epub 2015 Jun 10.'}, {'pmid': '25889222', 'type': 'RESULT', 'citation': 'Verschueren P, De Cock D, Corluy L, Joos R, Langenaken C, Taelman V, Raeman F, Ravelingien I, Vandevyvere K, Lenaerts J, Geens E, Geusens P, Vanhoof J, Durnez A, Remans J, Vander Cruyssen B, Van Essche E, Sileghem A, De Brabanter G, Joly J, Van der Elst K, Meyfroidt S, Westhovens R; CareRA study group. Patients lacking classical poor prognostic markers might also benefit from a step-down glucocorticoid bridging scheme in early rheumatoid arthritis: week 16 results from the randomized multicenter CareRA trial. Arthritis Res Ther. 2015 Apr 9;17(1):97. doi: 10.1186/s13075-015-0611-8.'}, {'pmid': '25483574', 'type': 'RESULT', 'citation': 'Meyfroidt S, Van der Elst K, De Cock D, Joly J, Westhovens R, Hulscher M, Verschueren P. Patient experiences with intensive combination-treatment strategies with glucocorticoids for early rheumatoid arthritis. Patient Educ Couns. 2015 Mar;98(3):384-90. doi: 10.1016/j.pec.2014.11.011. Epub 2014 Nov 20.'}, {'pmid': '25359382', 'type': 'RESULT', 'citation': 'Verschueren P, De Cock D, Corluy L, Joos R, Langenaken C, Taelman V, Raeman F, Ravelingien I, Vandevyvere K, Lenaerts J, Geens E, Geusens P, Vanhoof J, Durnez A, Remans J, Vander Cruyssen B, Van Essche E, Sileghem A, De Brabanter G, Joly J, Meyfroidt S, Van der Elst K, Westhovens R. Methotrexate in combination with other DMARDs is not superior to methotrexate alone for remission induction with moderate-to-high-dose glucocorticoid bridging in early rheumatoid arthritis after 16 weeks of treatment: the CareRA trial. Ann Rheum Dis. 2015 Jan;74(1):27-34. doi: 10.1136/annrheumdis-2014-205489. Epub 2014 Oct 30.'}, {'pmid': '24559216', 'type': 'RESULT', 'citation': 'Meyfroidt S, van Hulst L, De Cock D, Van der Elst K, Joly J, Westhovens R, Hulscher M, Verschueren P. Factors influencing the prescription of intensive combination treatment strategies for early rheumatoid arthritis. Scand J Rheumatol. 2014;43(4):265-72. doi: 10.3109/03009742.2013.863382. Epub 2014 Feb 24.'}, {'pmid': '22751567', 'type': 'RESULT', 'citation': 'Westhovens R, Verschueren P. Rheumatoid arthritis: defining remission in patients with RA in clinical practice. Nat Rev Rheumatol. 2012 Aug;8(8):445-7. doi: 10.1038/nrrheum.2012.111. Epub 2012 Jul 3. No abstract available.'}, {'pmid': '21454307', 'type': 'RESULT', 'citation': 'Verschueren P, Westhovens R. Optimal care for early RA patients: the challenge of translating scientific data into clinical practice. Rheumatology (Oxford). 2011 Jul;50(7):1194-200. doi: 10.1093/rheumatology/ker131. Epub 2011 Mar 30.'}, {'pmid': '18050189', 'type': 'RESULT', 'citation': 'Durez P, Malghem J, Nzeusseu Toukap A, Depresseux G, Lauwerys BR, Westhovens R, Luyten FP, Corluy L, Houssiau FA, Verschueren P. Treatment of early rheumatoid arthritis: a randomized magnetic resonance imaging study comparing the effects of methotrexate alone, methotrexate in combination with infliximab, and methotrexate in combination with intravenous pulse methylprednisolone. Arthritis Rheum. 2007 Dec;56(12):3919-27. doi: 10.1002/art.23055.'}, {'pmid': '9251634', 'type': 'RESULT', 'citation': 'Boers M, Verhoeven AC, Markusse HM, van de Laar MA, Westhovens R, van Denderen JC, van Zeben D, Dijkmans BA, Peeters AJ, Jacobs P, van den Brink HR, Schouten HJ, van der Heijde DM, Boonen A, van der Linden S. Randomised comparison of combined step-down prednisolone, methotrexate and sulphasalazine with sulphasalazine alone in early rheumatoid arthritis. Lancet. 1997 Aug 2;350(9074):309-18. doi: 10.1016/S0140-6736(97)01300-7.'}, {'pmid': '39117445', 'type': 'DERIVED', 'citation': 'Bertrand D, Joly J, Neerinckx B, Durez P, Lenaerts J, Joos R, Thevissen K, Zwaenepoel T, Vanhoof J, Di Romana S, Taelman V, Van Essche E, Corluy L, Ribbens C, Vanden Berghe M, Devinck M, Ajeganova S, Durnez A, Boutsen Y, Margaux J, Peene I, Van Offel J, Doumen M, Pazmino S, De Meyst E, Kulyk M, Creten N, Westhovens R, Verschueren P; CareRA2020 Study group. Effectiveness of methotrexate and bridging glucocorticoids with or without early introduction of a 6-month course of etanercept in early RA: results of the 2-year, pragmatic, randomised CareRA2020 trial. RMD Open. 2024 Aug 7;10(3):e004535. doi: 10.1136/rmdopen-2024-004535.'}]}, 'descriptionModule': {'briefSummary': 'In the Care in Rheumatoid Arthritis (CareRA) trial (NCT01172639) about 70% of early RA patients are in remission at the 2 year evaluation point independent of the combination scheme used.\n\nInteresting to see is that the 30% of insufficient responders can be identified in an early stage of the treatment course.\n\nThe purpose of the present study is to investigate if, for patients with an insufficient response to a COBRA-Slim regimen, accelerated access to a short course of anti-TNF therapy already early after treatment initiation (from w8 until w32) could improve outcomes compared to a more traditional treat to target sequence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older\n* Diagnosis of RA as defined by the American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) 2010 criteria for early RA\n* Early RA defined by a diagnosis made ≤ 1 year ago.\n* Use a reliable method of contraception for women of childbearing potential to be evaluated as in daily clinical practice\n* Able and willing to give written informed consent and to participate in the study\n* Understanding and able to write Dutch or French\n\nExclusion Criteria:\n\n* Previous treatment with:\n\n * Methotrexate (MTX) or leflunomide\n * cyclophosphamide, azathioprine or cyclosporine\n * sulphasalazine (SSZ) for more than 3 weeks\n * hydroxychloroquine for more than 6 weeks\n * oral Glucocorticoids (GC) for more than 4 weeks within 4 months before screening\n * oral GC at a daily dosage of more than 10 mg prednisone equivalent within 4 weeks before baseline\n * oral GC at a daily dosage equal to or less than 10 mg prednisone equivalent within 2 weeks before baseline\n * intra-articular GC within 4 weeks before BL\n * an investigational drug for the treatment/prevention of RA\n* History of chronic heart failure\n* History of severe infections or chronic infection\n* History of malignant neoplasm within 5 years\n* Contra indications for GC\n* Contra indications for TNF blocking agents\n* Contra indications for MTX or leflunomide\n* Psoriatic Arthritis\n* Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study\n* Pregnancy, breastfeeding or no use of a reliable method of contraception for woman of childbearing potential (as in daily clinical practice)\n* Alcohol or drug abuse\n* Active tuberculosis (TB)\n* Latent TB unless adequate prophylactic treatment is given according to local guidelines\n* No access to the Belgian Health Insurance system-'}, 'identificationModule': {'nctId': 'NCT03649061', 'acronym': 'CareRA2020', 'briefTitle': 'COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Effectiveness of a Combination of Methotrexate and a Step Down Glucocorticoid Regimen (COBRA-Slim) for Remission Induction in Patients With Early Rheumatoid Arthritis (RA), With or Without Fast Access to 24 Weeks of Tumor Necrosis Factor (TNF) Blockade in Insufficient Responders, a Randomized, Multicenter, Pragmatic Trial', 'orgStudyIdInfo': {'id': 'KCE-16002'}, 'secondaryIdInfos': [{'id': '2017-004054-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard COBRA-Slim induction', 'description': 'Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)', 'interventionNames': ['Drug: Leflunomide 10 milligram (MG)']}, {'type': 'EXPERIMENTAL', 'label': 'COBRA-Slim Bio-induction', 'description': 'Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)', 'interventionNames': ['Drug: Etanercept 50 MG/ML']}], 'interventions': [{'name': 'Etanercept 50 MG/ML', 'type': 'DRUG', 'description': 'Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme', 'armGroupLabels': ['COBRA-Slim Bio-induction']}, {'name': 'Leflunomide 10 milligram (MG)', 'type': 'DRUG', 'description': 'Leflunomide 10mg PO daily added to the COBRA-Slim scheme', 'armGroupLabels': ['standard COBRA-Slim induction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Bonheiden', 'state': 'Antwerpen', 'country': 'Belgium', 'facility': 'Imelda Ziekenhuis Bonheiden', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'zip': '2200', 'city': 'Herentals', 'state': 'Antwerpen', 'country': 'Belgium', 'facility': 'AZ Herentals', 'geoPoint': {'lat': 51.17655, 'lon': 4.83248}}, {'zip': '2170', 'city': 'Merksem', 'state': 'Antwerpen', 'country': 'Belgium', 'facility': 'ZNA Jan Palfijn', 'geoPoint': {'lat': 51.24623, 'lon': 4.44903}}, {'zip': '6060', 'city': 'Gilly', 'state': 'Henegouwen', 'country': 'Belgium', 'facility': 'GHdC Saint Joseph', 'geoPoint': {'lat': 50.42449, 'lon': 4.4789}}, {'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Reuma centrum Genk', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Reuma Clinic Genk', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '3500', 'city': 'Hasselt', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Reuma Instituut Hasselt', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '5530', 'city': 'Yvoir', 'state': 'Namur', 'country': 'Belgium', 'facility': 'CHU UCL Namur ASBL Site Godinne', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'zip': '9300', 'city': 'Aalst', 'state': 'Oost Vlaanderen', 'country': 'Belgium', 'facility': 'OLV Ziekenhuis Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'Regionaal Ziekenhuis Heilig Hart Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '1800', 'city': 'Vilvoorde', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'AZ Jan Portaels', 'geoPoint': {'lat': 50.92814, 'lon': 4.42938}}, {'zip': '8310', 'city': 'Bruges', 'state': 'West Vlaanderen', 'country': 'Belgium', 'facility': 'AZ St Lucas Brugge', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '8000', 'city': 'Bruges', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'AZ Sint Jan Brugge', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Saint Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaire Saint Luc (UCL)', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hôpital Erasme-ULB', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'overallOfficials': [{'name': 'Patrick Verschueren, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'P. Verschueren', 'class': 'OTHER'}, 'collaborators': [{'name': 'Belgium Health Care Knowledge Centre', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'P. Verschueren', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}