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ACTIVE NOT RECRUITING Phase 3

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

NCT04035005 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 1,013 participants
Start Date 2019-08-12
Est. Completion 2028-01-19
Phase Phase 3

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04035005

The ClinicalTrials.gov registry entry for NCT04035005 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,013 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04035005 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Florida, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04035005?

The interventions under investigation include: Placebo (DRUG), Ocrelizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04035005?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial