Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-03-29 @ 2:00 AM
Study NCT ID:
NCT05269004
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2022-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533411', 'term': 'ocrelizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2022-02-11', 'studyFirstSubmitQcDate': '2022-03-04', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0', 'timeFrame': 'Up to 44 months'}], 'secondaryOutcomes': [{'measure': 'Change in Expanded Disability Status Scale (EDSS) score over time', 'timeFrame': 'Week 0, 24, 48, 72, 96, 120, 168'}, {'measure': 'Change in 9-Hole Peg Test (9HPT) over time', 'timeFrame': 'Week 0, 24, 48, 72, 96, 120, 168'}, {'measure': 'Change in Timed 25-Foot Walk Test (T25FWT) over time', 'timeFrame': 'Week 0, 24, 48, 72, 96, 120, 168'}, {'measure': 'The number of T1 lesions and number of new or enlarging T2 lesions', 'timeFrame': 'Week 0, 24, 48, 72, 96, 120, 168'}, {'measure': 'The change in total volume of T2 lesions and in total non-enhancing T1 lesion volume', 'timeFrame': 'Week 0, 24, 48, 72, 96, 120, 168'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Prior eligibility for and previous participation in 1 of the Roche-sponsored Parent Studies WA21092, WA21093, or WA25046 with the participant either receiving ocrelizumab as an investigational medicinal product (IMP) or being in safety follow-up after treatment discontinuation\n* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate acceptable contraception during the treatment period and for at least 6 months or longer if the local label is more stringent after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet\n\nExclusion criteria\n\n* Concurrent participation in any clinical trial (other than the Parent study)\n* Unable or unwilling to comply with the requirements of the protocol'}, 'identificationModule': {'nctId': 'NCT05269004', 'acronym': 'OLERO', 'briefTitle': 'A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Multicenter, Single-Arm, Open-Label, Extension, Rollover Study To Evaluate The Long-Term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'MN43964'}, 'secondaryIdInfos': [{'id': '2021-005746-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ocrelizumab', 'description': 'Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046). Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.', 'interventionNames': ['Drug: Ocrelizumab']}], 'interventions': [{'name': 'Ocrelizumab', 'type': 'DRUG', 'description': 'Ocrelizumab will be administered based on the dosage and administration received at the time of rollover from the Parent study.', 'armGroupLabels': ['Ocrelizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Barrow Neurological Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Neuroscience Research LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'MS Center of California', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Hospital and Clinics', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94117', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Advanced Neurosciences Research LLC', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurology Associates PA', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurological Services of Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32860', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Vero Beach Neurology and Research Institute', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'zip': '30327', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Neuroscience Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60062', 'city': 'Northbrook', 'state': 'Illinois', 'country': 'United States', 'facility': 'Consultants in Neurology Ltd', 'geoPoint': {'lat': 42.12753, 'lon': -87.82895}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Univ School of Med', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas University Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Institute for Neurological Disorders', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '55422', 'city': 'Golden Valley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Clinic of Neurology', 'geoPoint': {'lat': 45.00969, 'lon': -93.34912}}, {'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198-8440', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers New Jersey Medical School Department of Neurology', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Holy Name Hospital', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '87131-0001', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11772', 'city': 'Patchogue', 'state': 'New York', 'country': 'United States', 'facility': 'South Shore Neurologic Associates PC', 'geoPoint': {'lat': 40.76565, 'lon': -73.01511}}, {'zip': '11790', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY at Stony Brook', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OnSite Clinical Solutions LLC', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Neurological Institute PA', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Atrium Health', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Raleigh Neurology Associates', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45267-0502', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Neurology Inc.', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43082', 'city': 'Westerville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Columbus Neuroscience', 'geoPoint': {'lat': 40.12617, 'lon': -82.92907}}, {'zip': '73104-5046', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Medical Research Foundation', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Neurological Specialties', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19001', 'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Neurological Associates', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '38018', 'city': 'Cordova', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Neurology Clinic PC', 'geoPoint': {'lat': 35.15565, 'lon': -89.7762}}, {'zip': '37934', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sibyl Wray MD Neurology PC', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Uni of Texas Health Science Center At Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '79410', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Bhupesh Dihenia M.D. P.A.', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Neurology Center of San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont Medical Center', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '98122-4470', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Neuroscience Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'MultiCare Health System Institute for Research and Innovation', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '1209', 'city': 'Ciudad Autonoma Bs As', 'country': 'Argentina', 'facility': 'Hospital Español'}, {'zip': '2000', 'city': 'Rosario', 'country': 'Argentina', 'facility': 'Fundacion Rosarina de Neurorehabilitacion', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': 'NSW 2065', 'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal North Shore Hospital', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': "St Vincent's Hospital Melbourne", 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Medizinische Universität Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '4040', 'city': 'Linz', 'country': 'Austria', 'facility': 'Barmherzige Brueder Konventspital', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'AKH - Medizinische Universität Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '230017', 'city': 'Grodno', 'state': 'Brest Oblast', 'country': 'Belarus', 'facility': 'Grodno University Hospital'}, {'zip': '2200045', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'State Institution Minsk Research and Practice Center of Surgery Transplantation and Hematology', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'zip': '210037', 'city': 'Vitebsk', 'country': 'Belarus', 'facility': 'Vitebsk Regional Clinical Hospital', 'geoPoint': {'lat': 55.1904, 'lon': 30.2049}}, {'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'AZ Sint Jan', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'UZA', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9900', 'city': 'Eeklo', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Alma', 'geoPoint': {'lat': 51.18703, 'lon': 3.55654}}, {'zip': '8800', 'city': 'Roeselare', 'country': 'Belgium', 'facility': 'AZ Delta Campus Westlaan', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'zip': '74605-020', 'city': 'Goinia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás'}, {'zip': '90610-000', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital So Lucas da PUCRS', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90620-130', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'IMV Pesquisa Neurologica Sociedade Simples Ltda', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '89202-165', 'city': 'Joinville', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'Clinica Neurológica e Neurocirúrgica de Joinville', 'geoPoint': {'lat': -26.30444, 'lon': -48.84556}}, {'zip': '20270-004', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Universitario Gaffree e Guinle', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '21941-913', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'HUCFF-UFRJ - Hospital Universitário Clementino Fraga Filho Universidade Federal do Rio de Janeiro', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '5800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'MHAT Avis Medica OOD Department of Neurology', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '1113', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'MHATNP Sveti Naum EAD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1142', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'University First MHAT-Sofia St. Joan Krastitel EAD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1309', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'National Heart Hospital EAD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1407', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Acibadem City Clinic 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S.M. 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Academician E.A. 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