A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
Running, not enrolling · Phase 3
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT05269004
- Run by
- Hoffmann-La Roche
- People needed
- 1300
- Starts
- 2022-05-03
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Concurrent participation in any clinical trial (other than the Parent study)
- Unable or unwilling to comply with the requirements of the protocol
Where it is running
- Barrow Neurological Institute — Phoenix, Arizona, United States
- Arizona Neuroscience Research LLC — Phoenix, Arizona, United States
- MS Center of California — Laguna Hills, California, United States
- Stanford Hospital and Clinics — Palo Alto, California, United States
- University of California San Francisco — San Francisco, California, United States
- University of California San Francisco — San Francisco, California, United States
- University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center) — Aurora, Colorado, United States
- Advanced Neurosciences Research LLC — Fort Collins, Colorado, United States
- Neurology Associates PA — Maitland, Florida, United States
- University of Miami — Miami, Florida, United States
- Neurological Services of Orlando — Orlando, Florida, United States
- University of South Florida — Tampa, Florida, United States
- Vero Beach Neurology and Research Institute — Vero Beach, Florida, United States
- Atlanta Neuroscience Institute — Atlanta, Georgia, United States
- Northwestern University — Chicago, Illinois, United States
- Consultants in Neurology Ltd — Northbrook, Illinois, United States
- Indiana Univ School of Med — Indianapolis, Indiana, United States
- Kansas University Medical Center — Kansas City, Kansas, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Wayne State University — Detroit, Michigan, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- Michigan Institute for Neurological Disorders — Farmington Hills, Michigan, United States
- Minneapolis Clinic of Neurology — Golden Valley, Minnesota, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Rhode Island Hospital — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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