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Research summary · 12 d ago

AI summary · not yet reviewedHuman studyInterventionalTrial registry record – peer review not applicable

Study of Remibrutinib in Secondary Progressive Multiple Sclerosis Patients

This interventional study aimed to evaluate the efficacy and safety of remibrutinib in 1275 patients with secondary progressive multiple sclerosis (SPMS). Participants were randomly assigned to receive either the active treatment or a placebo over a follow-up period of approximately 5 years, focusing on the time to 6-month confirmed disability progression (6mCDP). Results have not yet been reported.

Tags: #MSResearch
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Source: Read original source

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

Human efficacy: Not yet assessed
Mechanism: Not yet assessed
Evidence strength: Not yet assessed
Outcome: Not yet assessed

Why it matters

This research is significant as it seeks to provide vital data regarding a potential treatment option for SPMS, a challenging form of multiple sclerosis that currently has limited therapies.

What this does not prove

No results from the study are available, and the details shared do not constitute findings but rather outline the planned study methodology.

Next milestone

No next milestone was established from the available source.

Study facts

Study design: Interventional
Participants / samples: 1275 · estimated
Randomised: Yes
Controlled: Not reported
Primary endpoint met: Not reported
Relevant MS type: Not reported
Publication date: Not reported
Evidence reviewed: Trial registry record
Regulatory approval: Yes
Research areas: Not classified

Original sources

Trial registrationA Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis ↗

Supporting passages (13)

study design"studyType": "INTERVENTIONAL"

subjects"Secondary Progressive Multiple Sclerosis (SPMS)"

sample size"count": 1275

sample size basis"type": "ESTIMATED"

randomized"allocation": "RANDOMIZED"

regulatory approval"isFdaRegulatedDrug": true

intervention"description": "Remibrutinib (Blinded) active treatment, oral tablet"

comparator"description": "Matching placebo (binded), oral tablet"

primary endpoint"measure": "Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)"

follow up"timeFrame": "From baseline up to approximately 5 years"

findings"briefSummary": "The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)"

limitationsNo results are posted.

limitationsPlanned enrolment and endpoints are not findings.

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