Efficacy Study of Ocrelizumab in MS Models

This study aimed to evaluate the efficacy of the drug ocrelizumab in participants diagnosed with either relapsing-remitting multiple sclerosis (RRMS) or primary progressive multiple sclerosis (PPMS). It involved an estimated sample size of 60 participants and followed them for up to 1.6 years. No results have been posted yet.

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This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.

Why it matters

Understanding the efficacy of ocrelizumab for MS could inform treatment options and management strategies for these conditions, potentially impacting patient care.

What this does not prove

The findings are not yet available, and the planned enrollment and endpoints do not constitute results. As such, data to assess the effectiveness of ocrelizumab remains unreported.

Next milestone

No next milestone was established from the available source.

Study facts

Study design: Interventional
Participants / samples: 60 · ESTIMATED
Randomised: No
Controlled: Not reported
Primary endpoint met: Not reported
Relevant MS type: Not reported
Publication date: Not reported
Evidence reviewed: Trial registry record
Regulatory approval: No
Research areas: Not classified

Original sources

Trial registrationA Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis ↗

Supporting passages (11)

sample size60

sample size basisESTIMATED

study phasePHASE4

study designINTERVENTIONAL

randomizedNON_RANDOMIZED

regulatory approvalNo

interventionOcrelizumab

primary endpointRMS Cohort: Annualized Protocol-defined Relapse Rate

follow upUp to approximately 1.6 years

findings"eligibilityCriteria": "Inclusion Criteria:\n\n* Diagnosis of RMS/PPMS in accordance with the revised 2017 McDonald Criteria\n* EDSS score from 0-5.5 (RMS) or 3.0-6.5 (PPMS), inclusive, at screening and baseline\n* Documented MRI of brain with abnormalities consistent with MS before screening\n\nExclusion Criteria:\n\n* Diagnosis of PPMS or non-active secondary progressive multiple sclerosis (SPMS) (only for RMS cohort)\n* History of relapsing remitting multiple sclerosis (RRMS) or SPMS at screening (only for PPMS cohort)\n* Disease duration of more than 10 years in participants with an EDSS ≤ 2.0 at screening (only for RMS cohort)\n* History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)\n* Inability to complete an MRI scan or contraindication to Gd administration\n* Contraindications to mandatory pre-medications (i.e., corticosteroids and antihistamines)\n* Known presence of other neurologic disorders if they could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study\n* Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study\n* Known history of human immunodeficiency virus (HIV) infection\n* Lack of peripheral venous access\n* Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab), unless the last infusion was at least 6 months prior to screening\n* Positive screening tests for hepatitis B virus (HBV) and/or hepatitis C virus (HCV)",

limitationsNo results are posted. Planned enrolment and endpoints are not findings.

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