Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT01225393
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2010-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid Arthritis
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': 'C576689', 'term': 'pateclizumab'}, {'id': 'D000068879', 'term': 'Adalimumab'}, {'id': 'D000077339', 'term': 'Leflunomide'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2013-08-20', 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2010-10-18', 'dispFirstSubmitQcDate': '2013-08-20', 'studyFirstSubmitQcDate': '2010-10-19', 'dispFirstPostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR', 'timeFrame': 'Day 85'}, {'measure': 'Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLTA3698A', 'timeFrame': 'Length of study (through Day 85)'}], 'secondaryOutcomes': [{'measure': 'ACR20 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 20% responder criteria [ACR20] for their average response )', 'timeFrame': 'Day 85'}, {'measure': 'ACR50 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 50% responder criteria [ACR50] for their average response )', 'timeFrame': 'Day 85'}, {'measure': 'ACR70 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 70% responder criteria [ACR70] for their average response)', 'timeFrame': 'Day 85'}, {'measure': 'Tender joint count', 'timeFrame': 'Day 85'}, {'measure': 'Swollen joint count', 'timeFrame': 'Day 85'}, {'measure': 'Investigator Global Assessment of Disease Activity', 'timeFrame': 'Day 85'}, {'measure': 'Patient Global Assessment of Pain and Disease Activity', 'timeFrame': 'Day 85'}, {'measure': 'Health Assessment Questionnaire Disability Index', 'timeFrame': 'Day 85'}, {'measure': "Patient's Global Health or Short Form Health Survey (SF-36)", 'timeFrame': 'Day 85'}, {'measure': 'European League Against Rheumatism response rate', 'timeFrame': 'Day 85'}, {'measure': 'Serum C-reactive protein levels', 'timeFrame': 'Day 85'}, {'measure': 'Erythrocyte sedimentation rate', 'timeFrame': 'Day 85'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '25359150', 'type': 'DERIVED', 'citation': 'Kennedy WP, Simon JA, Offutt C, Horn P, Herman A, Townsend MJ, Tang MT, Grogan JL, Hsieh F, Davis JC. Efficacy and safety of pateclizumab (anti-lymphotoxin-alpha) compared to adalimumab in rheumatoid arthritis: a head-to-head phase 2 randomized controlled study (The ALTARA Study). Arthritis Res Ther. 2014 Oct 30;16(5):467. doi: 10.1186/s13075-014-0467-3.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter study enrolling patients with active rheumatoid arthritis (RA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of RA according to the 1987 revised ACR Criteria for the Classification of RA for at least 6 months prior to screening\n* Positive for rheumatoid factor or anti-cyclic citrullinated peptide (CCP) antibody, or both\n* Active disease, defined as: CRP \\>= 1.0 mg/dL; swollen joint count \\>= 6 (66 joint count); tender joint count \\>= 6 (68 joint count)\n* Previous inadequate clinical response to at least one disease-modifying anti-rheumatic drug (DMARD) consisting of either methotrexate (MTX) or leflunomide (LFU)\n* For patients currently receiving corticosteroids: Treatment at a stable dose during last 4 weeks prior to screening\n* For patients currently receiving non-steroidal anti-inflammatory drugs (NSAIDs): Treatment at a stable dose during last 4 weeks prior to screening\n* For patients currently receiving sulfasalazine or anti-malarials: Treatment initiated and continued for at least the last 6 months prior to screening and on a stable dose\n* For patients of reproductive potential (males and females): Willing to use a highly effective birth control method for the duration of the study according to local guidelines\n\nExclusion Criteria:\n\n* Pregnant, planning to become pregnant during the study, or breastfeeding\n* Clinically significant abnormal laboratory values or abnormal ECG or vital signs\n* History of anaphylactic reactions\n* Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome), however patients with secondary Sjogren's syndrome are eligible for the study\n* History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthritis, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, or other overlap syndrome)\n* Current or recent (within 4 weeks prior to screening) infection, including signs, symptoms or serology of any infection, including HIV, hepatitis B or C, tuberculosis\n* Administration of a live, attenuated vaccine within 1 month before dosing or anticipation that such a live attenuated vaccine will be required during the study\n* Previous treatment with anti-TNF biologics or other biologic agents, including anti-CD20-directed therapy (e.g. rituximab), anti-IL6-directed therapy (e.g. tocilizumab), or T cell-directed therapy (e.g. abatacept)"}, 'identificationModule': {'nctId': 'NCT01225393', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase II, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patient With Active Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'ALT4864g'}, 'secondaryIdInfos': [{'id': 'GA00932', 'type': 'OTHER', 'domain': 'Hoffmann-La Roche'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: MLTA3698A', 'Drug: leflunomide', 'Drug: methotrexate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: adalimumab', 'Drug: leflunomide', 'Drug: methotrexate', 'Drug: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C', 'interventionNames': ['Drug: leflunomide', 'Drug: methotrexate', 'Drug: placebo']}], 'interventions': [{'name': 'MLTA3698A', 'type': 'DRUG', 'description': 'Subcutaneous repeating dose', 'armGroupLabels': ['A']}, {'name': 'adalimumab', 'type': 'DRUG', 'description': 'Subcutaneous repeating dose', 'armGroupLabels': ['B']}, {'name': 'leflunomide', 'type': 'DRUG', 'description': 'Stable dose if not on methotrexate', 'armGroupLabels': ['A', 'B', 'C']}, {'name': 'methotrexate', 'type': 'DRUG', 'description': 'Stable dose if not on leflunomide', 'armGroupLabels': ['A', 'B', 'C']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Subcutaneous repeating dose', 'armGroupLabels': ['B', 'C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '40515', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '49009', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '39232', 'city': 'Flowood', 'state': 'Mississippi', 'country': 'United States', 'geoPoint': {'lat': 32.30959, 'lon': -90.13898}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '29406', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23320', 'city': 'Chesapeake', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.81904, 'lon': -76.27494}}, {'zip': '26301', 'city': 'Clarksburg', 'state': 'West Virginia', 'country': 'United States', 'geoPoint': {'lat': 39.28065, 'lon': -80.34453}}, {'zip': '1233', 'city': 'Sofia', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1407', 'city': 'Sofia', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1505', 'city': 'Sofia', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '00000', 'city': 'Santiago', 'country': 'Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '7501126', 'city': 'Santiago', 'country': 'Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '7510186', 'city': 'Santiago', 'country': 'Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '14059', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '50924', 'city': 'Cologne', 'country': 'Germany', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '99096', 'city': 'Erfurt', 'country': 'Germany', 'geoPoint': {'lat': 50.97734, 'lon': 11.03536}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '44649', 'city': 'Herne', 'country': 'Germany', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '39261', 'city': 'Zerbst', 'country': 'Germany', 'geoPoint': {'lat': 51.9662, 'lon': 12.08517}}, {'zip': '5600', 'city': 'Békéscsaba', 'country': 'Hungary', 'geoPoint': {'lat': 46.68333, 'lon': 21.1}}, {'zip': '1027', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1036', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': 'H-8200', 'city': 'Veszprém', 'country': 'Hungary', 'geoPoint': {'lat': 47.09327, 'lon': 17.91149}}, {'zip': '80000', 'city': 'Culiacán', 'country': 'Mexico', 'geoPoint': {'lat': 24.80209, 'lon': -107.39421}}, {'zip': '44340', 'city': 'Guadalajara', 'country': 'Mexico', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44600', 'city': 'Guadalajara', 'country': 'Mexico', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44690', 'city': 'Guadalajara', 'country': 'Mexico', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '37320', 'city': 'León', 'country': 'Mexico', 'geoPoint': {'lat': 25.60187, 'lon': -103.47698}}, {'zip': '21100', 'city': 'Mexicali', 'country': 'Mexico', 'geoPoint': {'lat': 32.62781, 'lon': -115.45446}}, {'zip': '06700', 'city': 'Mexico City', 'country': 'Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '97000', 'city': 'Mérida', 'country': 'Mexico', 'geoPoint': {'lat': 20.967, 'lon': -89.62318}}, {'zip': '44620', 'city': 'México', 'country': 'Mexico', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'zip': '64000', 'city': 'Monterrey, NL', 'country': 'Mexico', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '41', 'city': 'Lima', 'country': 'Peru', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'Lima 1', 'city': 'Lima', 'country': 'Peru', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'Lima 25', 'city': 'Lima', 'country': 'Peru', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'Lima 27', 'city': 'Lima', 'country': 'Peru', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'Lima 34', 'city': 'Lima', 'country': 'Peru', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'Lima 41', 'city': 'Lima', 'country': 'Peru', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'L27 Lima', 'city': 'San Isidro', 'country': 'Peru', 'geoPoint': {'lat': -12.09655, 'lon': -77.04258}}, {'zip': 'Lima 27', 'city': 'San Isidro', 'country': 'Peru', 'geoPoint': {'lat': -12.09655, 'lon': -77.04258}}, {'zip': '15-099', 'city': 'Bialystok', 'country': 'Poland', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '15-461', 'city': 'Bialystok', 'country': 'Poland', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '82-300', 'city': 'Elblag', 'country': 'Poland', 'geoPoint': {'lat': 54.1522, 'lon': 19.40884}}, {'zip': '64-000', 'city': 'Kościan', 'country': 'Poland', 'geoPoint': {'lat': 52.08829, 'lon': 16.64866}}, {'zip': '30-510', 'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-607', 'city': 'Lublin', 'country': 'Poland', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '02-653', 'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '430031', 'city': 'Baia Mare', 'country': 'Romania', 'geoPoint': {'lat': 47.65729, 'lon': 23.56808}}, {'zip': '010584', 'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '011172', 'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '400006', 'city': 'Cluj-Napoca', 'country': 'Romania', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '800578', 'city': 'Galati', 'country': 'Romania', 'geoPoint': {'lat': 45.43687, 'lon': 28.05028}}, {'zip': '39300', 'city': 'Torrelavega', 'state': 'Cantabria', 'country': 'Spain', 'geoPoint': {'lat': 43.34943, 'lon': -4.04785}}, {'zip': '15006', 'city': 'A Coruña', 'state': 'La Coruña', 'country': 'Spain', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '41071', 'city': 'Seville', 'state': 'Sevilla', 'country': 'Spain', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '38320', 'city': 'S. Cristobal de La Laguna', 'state': 'Tenerife', 'country': 'Spain'}], 'overallOfficials': [{'name': 'John C. Davis, Jr., M.D., M.P.H.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}