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NCT04035005 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
A Phase 3 study of Multiple Sclerosis, Primary Progressive, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 1,013
- Enrollment target
- 20
- Study locations
NCT04035005: Active Phase 3 study of Multiple Sclerosis, Primary Progressive, sponsored by Hoffmann-La Roche.
NCT04035005 is a Phase 3 study of Multiple Sclerosis, Primary Progressive that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 1,013 participants, above the 342-participant average among 7 other Multiple Sclerosis, Primary Progressive trials with a reported enrollment target (196% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04035005, a Phase 3 study of Multiple Sclerosis, Primary Progressive, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,013 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy and safety of ocrelizumab (Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study will consist of the following phases: screening, double-blind treatment, an optional post-double-progression ocrelizumab (PDP OCR) treatment, follow-up 1 (FU1), an optional open-label extension (OLE), and follow-up 2 (FU2).
Primary Outcome
Time to onset of cCDP12=time from randomization to the first occurrence of at least one of the following progression events: 1) 20% worsening from baseline in 9-hole Peg Test (9-HPT) confirmed for at least 12 weeks; 2) increase of ≥ 1.0 point from baseline in Expanded Disability Status Scale (EDSS) score in participants with a baseline EDSS score ≤5.5 or an increase of ≥ 0.5 point in participants with a baseline EDSS score of \>5.5 that is confirmed for at least 12 weeks. EDSS disability scale i
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ocrelizumab
Study Locations (20)
Other
- Cliniques Universitaires St-Luc - Brussels
- MS & Neurologisch Revalidatie Centrum - Overpelt
- Military Medical Academy HBAT - Pleven
- Multiprofile Hospital For Active Treatment Avis Medica - Pleven
- Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD - Sofia
Florida
- MS and Neuromuscular Center of Excellence - Clearwater
- Neurological Services of Orlando - Orlando
- Vero Neurology - Vero Beach
Ohio
- The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company - Columbus
- Columbus Neuroscience - Westerville
Victoria
- Austin Hospital - Heidelberg
- Royal Melbourne Hospital - Parkville
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Kansas
- University of Kansas Medical Center - Kansas City
Pennsylvania
- Albert Einstein Medical Center - Philadelphia
New South Wales
- Brain and Mind Research Institute - Camperdown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,013 participants |
| Start Date | 2019-08-12 |
| Est. Completion | 2028-01-19 |
| Phase | Phase 3 |
What the registry record for NCT04035005 still lists
NCT04035005 is an interventional study that assigns participants to a tested intervention. Its 1,013 participants enrollment target places it among the larger protocols in the corpus, above the 342-participant average among 7 other Multiple Sclerosis, Primary Progressive trials with a reported enrollment target (196% higher).
The record links to 1 condition, with Multiple Sclerosis, Primary Progressive appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04035005 names 20 study sites across 12 states, led by Other, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT04035005 about?
NCT04035005 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis". This study will evaluate the efficacy and safety of ocrelizumab (Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study will consist of the following phases: screening, double-blind treatmen...
What is the current status of trial NCT04035005?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,013 participants. The study started on 2019-08-12. Estimated completion is 2028-01-19.
What conditions does trial NCT04035005 study?
This clinical trial studies the following conditions: Multiple Sclerosis, Primary Progressive.
What interventions are being tested in trial NCT04035005?
The interventions under investigation include: Placebo (DRUG), Ocrelizumab (DRUG).
Who is sponsoring clinical trial NCT04035005?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04035005 being conducted?
This trial has 20 study locations across District of Columbia, Florida, Kansas, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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