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Monoclonal Antibodies

Long-Term Ocrelizumab for Multiple Sclerosis (OLERO Trial)

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
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 44 months
Awards & highlights

Summary

This trial is for people who have gotten ocrelizumab in a previous study and are continuing treatment or in a follow-up phase.

Who is the study for?
This trial is for people with Multiple Sclerosis who were previously in one of the Roche-sponsored studies (WA21092, WA21093, or WA25046) and received Ocrelizumab or are in safety follow-up. Women able to have children must use contraception during treatment and for 6 months after.Check my eligibility
What is being tested?
The study tests the long-term safety and effectiveness of Ocrelizumab in treating Multiple Sclerosis. It's a Phase IIIb trial where participants continue their current Ocrelizumab regimen from earlier 'Parent' studies without changing groups.See study design
What are the potential side effects?
Ocrelizumab may cause infusion reactions, infections, skin issues, lower immune response, potential risk to fetus if pregnant, and possibly other side effects not yet known due to its continued research status.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was part of a Roche study (WA21092, WA21093, WA25046) and received or followed up after ocrelizumab treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 44 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 44 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0
Secondary outcome measures
Change in 9-Hole Peg Test (9HPT) over time
Change in Expanded Disability Status Scale (EDSS) score over time
Change in Timed 25-Foot Walk Test (T25FWT) over time
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: OcrelizumabExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocrelizumab
2016
Completed Phase 3
~5770

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,436 Previous Clinical Trials
1,090,335 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
23,733 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,204 Previous Clinical Trials
889,006 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
17,059 Patients Enrolled for Multiple Sclerosis

Media Library

Ocrelizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05269004 — Phase 3
Multiple Sclerosis Research Study Groups: Ocrelizumab
Multiple Sclerosis Clinical Trial 2023: Ocrelizumab Highlights & Side Effects. Trial Name: NCT05269004 — Phase 3
Ocrelizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05269004 — Phase 3
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT05269004 — Phase 3
~867 spots leftby Dec 2029
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