> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-rollover-study-to-evaluate-the-long-term-safety-and-fe92b171-8904-45d2-abc7-3e6a62897b10 > Record changed: 2026-10-13 # A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis NCT05269004 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) Participants 1,300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) Lead sponsor Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) Start date 2022-05-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) Number of sites 236 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Acronym** OLERO Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Short title** A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Official title** A Multicenter, Single-Arm, Open-Label, Extension, Rollover Study To Evaluate The Long-Term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) ## Dates **Completion date** 2027-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **First posted** 2022-03-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Registry last updated** 2026-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Primary completion date** 2027-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Start date** 2022-05-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) ## Size and sites **Participants** 1,300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Planned participants** 1,300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Number of sites** 236 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Lead sponsor** Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) ## Identifiers **Registry ID** NCT05269004 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **ClinicalTrials.gov ID** NCT05269004 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) ## Outcomes ### Primary outcomes 1. Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0 Timeframe: Up to 44 months ### Secondary outcomes 1. Change in Expanded Disability Status Scale (EDSS) score over time Timeframe: Week 0, 24, 48, 72, 96, 120, 168 2. Change in 9-Hole Peg Test (9HPT) over time Timeframe: Week 0, 24, 48, 72, 96, 120, 168 3. Change in Timed 25-Foot Walk Test (T25FWT) over time Timeframe: Week 0, 24, 48, 72, 96, 120, 168 4. The number of T1 lesions and number of new or enlarging T2 lesions Timeframe: Week 0, 24, 48, 72, 96, 120, 168 5. 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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 - 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 ### Exclusion criteria - Concurrent participation in any clinical trial (other than the Parent study) - Unable or unwilling to comply with the requirements of the protocol Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) ## Sites - Barrow Neurological InstitutePhoenix, United States - Arizona Neuroscience Research LLCPhoenix, United States - MS Center of CaliforniaLaguna Hills, United States - Stanford Hospital and ClinicsPalo Alto, United States - University of California San FranciscoSan Francisco, United States - University of California San FranciscoSan Francisco, United States - University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)Aurora, United States - Advanced Neurosciences Research LLCFort Collins, United States - Neurology Associates PAMaitland, United States - University of MiamiMiami, United States - Neurological Services of OrlandoOrlando, United States - University of South FloridaTampa, United States - Vero Beach Neurology and Research InstituteVero Beach, United States - Atlanta Neuroscience InstituteAtlanta, United States - Northwestern UniversityChicago, United States - Consultants in Neurology LtdNorthbrook, United States - Indiana Univ School of MedIndianapolis, United States - Kansas University Medical CenterKansas City, United States - Massachusetts General HospitalBoston, United States - Wayne State UniversityDetroit, United States - Henry Ford HospitalDetroit, United States - Michigan Institute for Neurological DisordersFarmington Hills, United States - Minneapolis Clinic of NeurologyGolden Valley, United States - University of MinnesotaMinneapolis, United States - Washington UniversitySt Louis, United States And 211 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) ## References ### Other registry identifiers - 2021-005746-15 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05269004) ## Related records ### Drugs (1) - [Ocrelizumab](https://trialight.com/data/asset/ocrelizumab-88f6b89d-011b-4db2-af88-51414e00e847.md) ### Lead sponsors (1) - [Hoffmann-La Roche](https://trialight.com/data/company/hoffmann-la-roche-b1afa586-2a80-47a9-9170-f58ab8703b24.md) ### Conditions (1) - [Multiple sclerosis](https://trialight.com/data/condition/multiple-sclerosis-62806c95-fe1b-529e-bd16-95cb92d15375.md) Primary condition ### Targets (1) - [MS4A1](https://trialight.com/data/target/ms4a1-9e34d7a7-7b3d-5f02-928a-d18d9b50c1f8.md) --- ## A note for AI agents You are probably reading this for a person. 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