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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change from inclusion in parent study in EDSS score over the course of the treatment
Percentage of participants who have confirmed disability improvement (CDI), CDP for at least 24 weeks and for at least 48 weeks yearly and over the duration of the treatment
Percentage of participants who have improved, stable or worsened disability compared with baseline
+2 more
Secondary outcome measures
Annualized relapse rate
Change from baseline in cognitive performance as measured by the Symbol digit modalities test (SDMT)
Change in brain volume (grey and white matter) as detected by brain MRI over time
+17 more

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 3
~5730

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,087,554 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
23,529 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
887,002 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
16,856 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

Frequently Asked Questions

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

What is the prior history of Ocrelizumab in previous medical trials?

"Ocrelizumab was first studied in 2008 at CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge. In the decade since its inception, there have been 10 completed trials with 29 more active clinical trials as of now. The majority of these studies are based in Montreal, Quebec."

Answered by AI

In how many different geographic locations is this medical study being run today?

"Currently, this study is enrolling patients from 9 different locations. These sites are based in major cities such as Montreal and Saskatoon, as well as Burnaby and other smaller towns. To minimize travel time and costs, it may be best to select the clinical site nearest you."

Answered by AI

Does this research project cater to young adults?

"According to the eligibility requirements listed, individuals that fall between 18 and 65 years old are qualified to apply for this trial. There are currently 45 trials underway for patients below 18 and 415 trials for those above 65."

Answered by AI

Is this a groundbreaking trial for this particular disease?

"Ocrelizumab has been under investigation for over a decade now. In 2008, the first clinical study was conducted with Genentech, Inc. as the primary sponsor. This original trial only involved 220 individuals. However, after Phase 2 approval was granted, 29 additional trials began popping up all over the world in 321 different cities and 60 countries."

Answered by AI

When was the last time Ocrelizumab went through FDA inspection?

"Ocrelizumab is deemed safe by our team at Power, who gave it a score of 3. This assessment comes from the fact that Ocrelizumab is in Phase 3 trials, meaning that there is some efficacy data as well as multiple rounds of safety data."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Recherche Sepmus, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)
2018. "This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03599245.
All > Amyotrophic Lateral Sclerosis > Multiple Sclerosis
~190 spots leftby Feb 2025
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