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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
No Placebo-Only Group
Pivotal Trial

OLERO Trial 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.

OLERO Trial 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.

OLERO Trial 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

Side effects data

From 2022 Phase 3 trial • 821 Patients • NCT01247324
31%
Infusion related reaction
14%
Upper respiratory tract infection
13%
Urinary tract infection
11%
Nasopharyngitis
8%
Headache
7%
Depression
6%
Arthralgia
6%
Back pain
5%
Fatigue
5%
Insomnia
5%
Sinusitis
4%
Influenza like illness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ocrelizumab
Interferon Beta-1a 44 mcg SC

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.

OLERO 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
~5510

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,421 Previous Clinical Trials
1,079,338 Total Patients Enrolled
33 Trials studying Multiple Sclerosis
16,731 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,194 Previous Clinical Trials
885,880 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
17,058 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the chances of negative side effects from Ocrelizumab?

"The available evidence suggests that Ocrelizumab is safe to use, so it received a score of 3."

Answered by AI

How many different hospitals are testing this new medication?

"This trial is currently underway at 31 locations, including Hope Research Institute in Phoenix, MultiCare Health System Institute for Research and Innovation in Tacoma, and SUNY at Stony Brook in Stony Brook."

Answered by AI

When will recruitment for this research project be completed?

"The sponsor, Hoffmann-La Roche, needs to recruit 1300 eligible patients from various locations, including Hope Research Institute in Phoenix, Arizona and MultiCare Health System Institute for Research and Innovation in Tacoma, Washington."

Answered by AI

Are people still allowed to sign up for this experiment?

"Yes, this trial is still looking for participants. The information on clinicaltrials.gov shows that the trial was posted on 5/3/2022 and was last updated on 10/17/2022. They are looking for 1300 people to participate at 31 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Texas
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
What site did they apply to?
Neurological Services of Orlando
Neurology Associates PA
Uni of Texas Health Science Center At Houston

Why did patients apply to this trial?

I have multiple sclerosis.
PatientReceived no prior treatments
~665 spots leftby Dec 2025