Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT01011959
Status:
COMPLETED
Last Update Posted:
2013-09-30
First Post:
2009-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C000592401', 'term': 'sarilumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-27', 'studyFirstSubmitDate': '2009-11-10', 'studyFirstSubmitQcDate': '2009-11-10', 'lastUpdatePostDateStruct': {'date': '2013-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo', 'timeFrame': '10 weeks'}], 'secondaryOutcomes': [{'measure': 'To evaluate exploratory efficacy endpoints', 'timeFrame': 'over 10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This is a randomized study of the safety and tolerability of multiple doses of REGN88 in rheumatoid arthritis patients who are receiving treatment with methotrexate.', 'detailedDescription': 'This is a multi-centered, randomized, double-blind, placebo-controlled, ascending parallel-group study of the safety and tolerability of REGN88 in patients with rheumatoid arthritis who are receiving concomitant methotrexate.\n\nThis study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will not begin until enrollment in Part B is complete.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with an established diagnosis of Rheumatoid Arthritis\n* Patients currently treated with concomitant methotrexate for at least 12 weeks, with a stable dose for at least 6 weeks\n\nExclusion Criteria:\n\n* Persistent chronic or current active infections\n* Patients who have taken anakinra within 2 weeks\n* Patients who have taken etanercept, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 4 weeks\n* Patients who have taken adalimumab within 6 weeks\n* Patients who have taken abatacept, azathioprine, cyclophosphamide or infliximab within 12 weeks\n* Patients who have taken leflunomide or rituximab within 6 months\n* Patients who have had prior treatment with tocilizumab or any other anti-IL-6 medication\n* Significant arthritis or other medical condition that could interfere with study evaluations\n* Participation in any clinical research study evaluating another investigational drug within 30 days'}, 'identificationModule': {'nctId': 'NCT01011959', 'briefTitle': 'A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Parallel-group Study of the Safety and Tolerability of REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate', 'orgStudyIdInfo': {'id': '6R88-RA-0802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'dose 1 vs. placebo', 'interventionNames': ['Biological: REGN88']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'dose 2 vs. placebo', 'interventionNames': ['Biological: REGN88']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'dose 3 vs. placebo', 'interventionNames': ['Biological: REGN88']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'dose 4 vs. placebo', 'interventionNames': ['Biological: REGN88']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5', 'description': 'dose 5 vs. placebo', 'interventionNames': ['Biological: REGN88']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6', 'description': 'dose 6 vs. placebo', 'interventionNames': ['Biological: REGN88']}], 'interventions': [{'name': 'REGN88', 'type': 'BIOLOGICAL', 'description': 'This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will begin when enrollment into Part B is complete.', 'armGroupLabels': ['1', '2', '3', '4', '5', '6']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'city': 'Palm Harbor', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'city': 'Flowood', 'state': 'Mississippi', 'country': 'United States', 'geoPoint': {'lat': 32.30959, 'lon': -90.13898}}, {'city': 'Kalamzaoo', 'state': 'Missouri', 'country': 'United States'}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'city': 'Orangeburg', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 33.49182, 'lon': -80.85565}}, {'city': 'Hixson', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.14063, 'lon': -85.23273}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Allen Radin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}