Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-03 @ 2:34 AM
Study NCT ID:
NCT01878318
Status:
WITHDRAWN
Last Update Posted:
2016-11-02
First Post:
2013-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Venezuela']}, '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': 'D008727', 'term': 'Methotrexate'}, {'id': 'C502936', 'term': 'tocilizumab'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2013-06-06', 'studyFirstSubmitQcDate': '2013-06-12', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in extent and degree of synovitis in the hand assessed by MRI according to the OMERACT RAMRIS scale', 'timeFrame': 'from baseline to Week 24'}], 'secondaryOutcomes': [{'measure': 'Radiological changes in the hand according to the modified Sharp scale', 'timeFrame': 'from baseline to Week 24'}, {'measure': 'Change in Ritchie articular index', 'timeFrame': 'from baseline to Week 24'}, {'measure': 'Proportion of patients with American College of Rheumatology (ACR 20/50/70) response at Weeks 12 and 24', 'timeFrame': 'Weeks 12 and 24'}, {'measure': 'Change in pain: Visual analogue scale (VAS)', 'timeFrame': 'from baseline to Week 24'}, {'measure': 'Change in disability: Stanford Health Assessment Questionnaire', 'timeFrame': 'from baseline to Week 24'}, {'measure': 'Change in FACIT-fatigue questionnaire', 'timeFrame': 'from baseline to Week 24'}, {'measure': 'Change in disease activity: Disease activity score 28 - erythrocyte sedimentation rate (DAS28-ESR)', 'timeFrame': 'from baseline to Week 28'}, {'measure': 'Change in C-reactive protein', 'timeFrame': 'from baseline to Week 24'}, {'measure': 'Change in immunologic parameters: Rheumatic factor/anti-CCP', 'timeFrame': 'from baseline to Week 24'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'approximately 2 years'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This open-label, single arm study will evaluate the effect of RoActemra/Actemra in combination with methotrexate on articular damage in the hand (synovitis/osteitis and erosions) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to non-biological disease-modifying ante-rheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Diagnosis of rheumatoid arthritis according to ACR/EULAR classification (2010) of \\>/= 6 months duration\n* Active moderate to severe rheumatoid arthritis (DAS \\>/= 3.2)\n* Swollen joint count (SJC) \\>/= 6, tender joint count \\>/= 8\n* Synovitis in the dominant hand\n* Inadequate response to stable dose of a non-biological DMARD for at least 3 months\n* Oral corticosteroids must have been on stable dose for at least 25 out of 28 days before first dose of study drug\n* Patient on outpatient treatment\n\nExclusion Criteria:\n\n* Major surgery (including joint surgery) in the 8 weeks prior to screening, or planned major surgery within 6 months of randomization\n* Rheumatic autoimmune disease other than rheumatoid arthritis\n* American College of Rheumatology (ACR) functional class IV\n* History of or current inflammatory joint disease other than rheumatoid arthritis\n* Previous inadequate response to a biologic DMARD; prior biologic therapy for no longer than 1 month is allowed if discontinued for reasons of tolerability at least 6 months prior to study recruitment\n* Intra-articular or parenteral corticosteroids within 6 weeks prior to study start\n* Inadequate hematologic, renal or liver function\n* Positive for hepatitis B, hepatitis C or HIV infection\n* Pregnant or lactating women\n* History of severe allergic reactions or anaphylaxis to human, humanized or mural monoclonal antibodies\n* Current infections or history of recurrent infections\n* History of or currently active primary or acquired immunodeficiency\n* Active tuberculosis requiring treatment in the previous 3 years\n* Body weight \\> 150 kg'}, 'identificationModule': {'nctId': 'NCT01878318', 'briefTitle': 'A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Open Label Study to Describe the Effect of Tocilizumab in Combination With MTX in the Evolution of Articular Damage (Synovitis/Osteitis and Erosions) Evaluated by MRI in the Hand of Patients With Moderate to Severe Rheumatoid Arthritis (RA) and Inadequate Response to Non-biological DMARDs', 'orgStudyIdInfo': {'id': 'ML28204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RoActemra/Actemra', 'interventionNames': ['Drug: methotrexate', 'Drug: tocilizumab [RoActemra/Actemra]']}], 'interventions': [{'name': 'methotrexate', 'type': 'DRUG', 'description': 'stable dose', 'armGroupLabels': ['RoActemra/Actemra']}, {'name': 'tocilizumab [RoActemra/Actemra]', 'type': 'DRUG', 'description': '8 mg/kg intravenously every 4 weeks, 24 weeks', 'armGroupLabels': ['RoActemra/Actemra']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}