Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-26 @ 12:06 PM
Study NCT ID:
NCT00962832
Status:
COMPLETED
Last Update Posted:
2016-08-12
First Post:
2009-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'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': 'C577244', 'term': 'rontalizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 238}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'dispFirstSubmitDate': '2016-08-10', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-10', 'studyFirstSubmitDate': '2009-08-19', 'dispFirstSubmitQcDate': '2016-08-10', 'studyFirstSubmitQcDate': '2009-08-19', 'dispFirstPostDateStruct': {'date': '2016-08-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of responders at Week 24', 'timeFrame': 'Until study discontinuation or up to 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Time-adjusted area under the curve (AUC) of the BILAG index global score', 'timeFrame': 'Until study discontinuation or up to 24 weeks'}, {'measure': 'Treatment failure status', 'timeFrame': 'Until study discontinuation or up to 24 weeks'}, {'measure': 'Time to treatment failure', 'timeFrame': 'Until study discontinuation or up to 24 weeks'}]}, 'conditionsModule': {'keywords': ['rhuMAb IFNalpha', 'SLE'], 'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '26038091', 'type': 'DERIVED', 'citation': 'Kalunian KC, Merrill JT, Maciuca R, McBride JM, Townsend MJ, Wei X, Davis JC Jr, Kennedy WP. A Phase II study of the efficacy and safety of rontalizumab (rhuMAb interferon-alpha) in patients with systemic lupus erythematosus (ROSE). Ann Rheum Dis. 2016 Jan;75(1):196-202. doi: 10.1136/annrheumdis-2014-206090. Epub 2015 Jun 2.'}, {'pmid': '25861459', 'type': 'DERIVED', 'citation': 'Kennedy WP, Maciuca R, Wolslegel K, Tew W, Abbas AR, Chaivorapol C, Morimoto A, McBride JM, Brunetta P, Richardson BC, Davis JC Jr, Behrens TW, Townsend MJ. Association of the interferon signature metric with serological disease manifestations but not global activity scores in multiple cohorts of patients with SLE. Lupus Sci Med. 2015 Mar 28;2(1):e000080. doi: 10.1136/lupus-2014-000080. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase II, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rontalizumab compared with placebo in patients with moderately to severely active systemic lupus erythematosus (SLE).', 'detailedDescription': 'The study will be conducted in 3 parts. Parts 1 and 2 of the study will include a double-blind treatment period of 24 weeks and a safety follow-up period of 48 weeks for participants who do not continue onto Part 3. Patients meeting the eligibility criteria for enrollment in Part 3, will enter Part 3 after completion of the Week 24 visit but prior to completion of the Week 72 visit. In Part 1, participants will be randomized in a 2:1 ratio (active drug:placebo) to receive either rontalizumab 750 mg or matching placebo intravenously every 4 weeks for 24 weeks. Part 2 was will be initiated upon the completion of recruitment for Part 1. In Part 2, participants will be randomized in a 2:1 ratio (active drug:placebo) to receive either rontalizumab 300 mg or matching placebo subcutaneously every 2 weeks for 24 weeks. After Week 24, patients will enter a 48-week safety follow-up period, or, after the open label extension became available via protocol amendment, will have the option of entering Part 3 of the study, if eligible. In Part 3, all participants will receive rontalizumab 750 mg intravenously every 4 weeks for 120 weeks (up to 144 weeks total).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of SLE.\n* Active disease at the time of screening.\n* Agreement to use an effective form of contraception for the duration of the study.\n\nExclusion Criteria:\n\n* Acutely life- or organ-threatening manifestations of systemic lupus erythematosus (SLE) (eg, proliferative nephritis, unstable neuropsychiatric disease).\n* Pregnancy or breastfeeding.\n* History of severe allergic or anaphylactic reactions to monoclonal antibodies or intravenous (IV) immunoglobulin.\n* Significant, uncontrolled medical disease in any organ system not related to SLE that in the investigator's opinion would preclude patient participation.\n* Concomitant conditions that required systemic corticosteroid use within 1 year prior to screening. Use of topical, intraarticular, or inhaled corticosteroids is not exclusionary.\n* History of cancer within 5 years of screening.\n* Any current or recent (within 4 weeks of screening) signs or symptoms of infection, except for minor infections, fungal infections of the nail beds, or oral or vaginal candidiasis.\n* History of severe systemic bacterial, fungal, viral, or parasitic infections (2 or more hospitalizations or 2 or more courses of IV antibiotics) within 6 months prior to screening"}, 'identificationModule': {'nctId': 'NCT00962832', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rontalizumab (rhuMAb IFNalpha) in Patients With Moderately to Severely Active Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'IFN4575g'}, 'secondaryIdInfos': [{'id': 'GA00806', 'type': 'OTHER', 'domain': 'Hoffmann-La Roche'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1 - Placebo intravenously', 'description': 'Participants received placebo intravenously every 4 weeks for 24 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 - Rontalizumab 750 mg intravenously', 'description': 'Participants received rontalizumab 750 mg intravenously every 4 weeks for 24 weeks.', 'interventionNames': ['Drug: Rontalizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2 - Placebo subcutaneously', 'description': 'Participants received placebo subcutaneously every 2 weeks for 24 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - Rontalizumab 300 mg subcutaneously', 'description': 'Participants received rontalizumab 300 mg subcutaneously every 2 weeks for 24 weeks.', 'interventionNames': ['Drug: Rontalizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3 - Rontalizumab 750 mg intravenously', 'description': 'Participants received rontalizumab 750 mg intravenously every 4 weeks for 120 weeks.', 'interventionNames': ['Drug: Rontalizumab']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo was supplied as a sterile liquid solution.', 'armGroupLabels': ['Part 1 - Placebo intravenously', 'Part 2 - Placebo subcutaneously']}, {'name': 'Rontalizumab', 'type': 'DRUG', 'description': 'Rontalizumab was supplied as a sterile liquid solution.', 'armGroupLabels': ['Part 1 - Rontalizumab 750 mg intravenously', 'Part 2 - Rontalizumab 300 mg subcutaneously', 'Part 3 - Rontalizumab 750 mg intravenously']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94578', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '83814', 'city': "Coeur d'Alene", 'state': 'Idaho', 'country': 'United States', 'geoPoint': {'lat': 47.67768, 'lon': -116.78047}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '21502', 'city': 'Cumberland', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.65287, 'lon': -78.76252}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11020', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '11576', 'city': 'Roslyn', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.79982, 'lon': -73.65096}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '18015', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29406', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77034', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77479', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '22205', 'city': 'Arlington', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': 'C1015ABO', 'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1181ACH', 'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1284AEB', 'city': 'Ciudad Autonoma Buenos A.', 'country': 'Argentina'}, {'zip': 'S2000DSV', 'city': 'Rosario', 'country': 'Argentina', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': 'T4000AXL', 'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'city': 'Barranquilla', 'country': 'Colombia', 'geoPoint': {'lat': 10.96854, 'lon': -74.78132}}, {'city': 'Barranquilla-Atlantico', 'country': 'Colombia'}, {'city': 'Bogota D.C.', 'country': 'Colombia'}, {'city': 'Bogotá', 'country': 'Colombia', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Bucaramanga', 'country': 'Colombia', 'geoPoint': {'lat': 7.125, 'lon': -73.11895}}, {'city': 'Chia-Cundinamarca', 'country': 'Colombia'}, {'city': 'Medellin-Antioquia', 'country': 'Colombia'}, {'zip': '44280', 'city': 'Guadalajara', 'country': 'Mexico', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '14000', 'city': 'Mexico City', 'country': 'Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '07760', 'city': 'Mexico Ctiy', 'country': 'Mexico'}, {'zip': '06726', 'city': 'México', 'country': 'Mexico', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'zip': '06700', 'city': 'Miexico City', 'country': 'Mexico'}, {'zip': '58070', 'city': 'Morelia', 'country': 'Mexico', 'geoPoint': {'lat': 19.70078, 'lon': -101.18443}}, {'zip': '78240', 'city': 'San Luis Potosi S.l.p.', 'country': 'Mexico'}, {'zip': '85-168', 'city': 'Bydgoszcz', 'country': 'Poland', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '82-300', 'city': 'Elblag', 'country': 'Poland', 'geoPoint': {'lat': 54.1522, 'lon': 19.40884}}, {'zip': '26-200', 'city': 'Gmina Końskie', 'country': 'Poland', 'geoPoint': {'lat': 51.19166, 'lon': 20.40607}}, {'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': '60-218', 'city': 'Poznan', 'country': 'Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '02-637', 'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '420064', 'city': "Kazan'", 'country': 'Russia', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '115522', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '634063', 'city': 'Tomsk', 'country': 'Russia', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'zip': '150030', 'city': 'Yaroslavl', 'country': 'Russia', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}], 'overallOfficials': [{'name': 'William Kennedy, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}