Multiple Sclerosis
Conditions
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 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.
Interventions
DRUGOcrelizumab
Ocrelizumab will be administered based on the dosage and administration received at the time of rollover from the Parent study.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0 | Up to 44 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in Expanded Disability Status Scale (EDSS) score over time | Week 0, 24, 48, 72, 96, 120, 168 |
| Change in 9-Hole Peg Test (9HPT) over time | Week 0, 24, 48, 72, 96, 120, 168 |
| Change in Timed 25-Foot Walk Test (T25FWT) over time | Week 0, 24, 48, 72, 96, 120, 168 |
| The number of T1 lesions and number of new or enlarging T2 lesions | Week 0, 24, 48, 72, 96, 120, 168 |
| The change in total volume of T2 lesions and in total non-enhancing T1 lesion volume | Week 0, 24, 48, 72, 96, 120, 168 |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Croatia, Czechia, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Spain, Sweden, Switzerland, Tunisia, Turkey (Türkiye), Ukraine, United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed