A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Single-Arm, Open-Label, Extension, Rollover Study To Evaluate The Long-Term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Ocrelizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ocrelizumab<br>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. | Drug: Ocrelizumab<br>* Ocrelizumab will be administered based on the dosage and administration received at the time of rollover from the Parent study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0 |  | Up to 44 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |