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Monoclonal Antibodies

Ocrelizumab for Multiple Sclerosis

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Evidence of any adverse event potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation
Participants in a severely immunocompromised state until the condition resolves
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test if a drug is effective and safe for people with multiple sclerosis who were in a previous trial.

Who is the study for?
This trial is for individuals with Multiple Sclerosis who previously participated in Roche's ocrelizumab phase IIIb/IV trials. They must understand and agree to the study rules, have completed prior ocrelizumab treatments, and not be severely immunocompromised or planning pregnancy within 6 months after the last dose.
What is being tested?
The study is testing the long-term effectiveness and safety of a medication called Ocrelizumab in patients with Multiple Sclerosis who were part of earlier related trials. It extends previous research to gather more data on this treatment.
What are the potential side effects?
Ocrelizumab may cause allergic reactions, weaken the immune system leading to infections, or other adverse events that could require stopping treatment as per medical guidelines.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have experienced side effects from ocrelizumab that require stopping its use.
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My immune system is currently not severely weakened.
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I do not have any health conditions that would prevent me from taking certain medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of participants who have improved, stable or worsened disability compared with baseline
Time to 20% increase in timed 25-foot walk test (T25FWT)
Secondary study objectives
Percentage of participants with no evidence of progression (NEP)
Percentage of participants with no evidence of progression sustained for at least 24 weeks and no active disease (NEPAD)
Percentage of participants with no evidence of protocol-defined disease activity (NEDA) yearly and over the duration of the treatment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: OcrelizumabExperimental Treatment1 Intervention
Participants will receive a single 600-mg infusion of Ocrelizumab every 24 weeks up to Week 72 of this study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocrelizumab
2016
Completed Phase 4
~8600

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,456 Previous Clinical Trials
1,096,112 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
24,020 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,225 Previous Clinical Trials
894,860 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
17,346 Patients Enrolled for Multiple Sclerosis

Media Library

Ocrelizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03599245 — Phase 3
Multiple Sclerosis Research Study Groups: Ocrelizumab
Multiple Sclerosis Clinical Trial 2023: Ocrelizumab Highlights & Side Effects. Trial Name: NCT03599245 — Phase 3
Ocrelizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03599245 — Phase 3
~38 spots leftby Feb 2025
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