Status:
ACTIVE_NOT_RECRUITING
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ocr...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT05269004
Start Date
May 3 2022
End Date
December 31 2029
Last Update
December 31 2025
Active Locations (234)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
Arizona Neuroscience Research LLC
Phoenix, Arizona, United States, 85032
3
MS Center of California
Laguna Hills, California, United States, 92653
4
Stanford Hospital and Clinics
Palo Alto, California, United States, 94304