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Monoclonal Antibodies

Group of patients who receive satralizumab for Facioscapulohumeral Muscular Dystrophy (REINFORCE Trial)

Phase 2

Recruiting

Research Sponsored by Centre Hospitalier Universitaire de Nice

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Capable of understanding the written informed consent, and providing signed, dated, and witnessed written informed consent

Male or female subjects between the ages of 18 and 65 years, inclusive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 96

Awards & highlights

REINFORCE Trial Summary

This trial is studying a type of muscle disease called facioscapulohumeral muscular dystrophy (FSHD), which is caused by a gene mutation leading to muscle cell death and weakness. Recent

Who is the study for?

This trial is for adults with FSHD1, a type of muscular dystrophy. Participants should have evidence of muscle weakness and meet specific clinical criteria. Those with other forms of muscular dystrophy or conditions that might interfere with the study are excluded.Check my eligibility

What is being tested?

The study tests Satralizumab, an IL-6 receptor blocker thought to reduce inflammation in muscles affected by FSHD1. It's compared against a placebo in a randomized, double-blind setup to assess its effectiveness and safety.See study design

What are the potential side effects?

Satralizumab may cause potential side effects such as infections due to immune system suppression, liver issues, increased cholesterol levels, gastrointestinal problems, and hypersensitivity reactions.

REINFORCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can understand and have signed the consent form for the trial.

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I am between 18 and 65 years old.

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My body weight is 100 kg or less.

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My MRI shows significant fat in my muscles but not over 50%.

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I can walk on my own without any help.

REINFORCE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 96

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 96

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 96 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The study will evaluate safety and tolerability of satralizumab compared to placebo, measured by frequency of clinically significant changes from baseline in laboratory test, vital signs, and physical examination results during the Double Blind period

The study will evaluate the efficacy of satralizumab compared to placebo, measured by the change during the Double Blind (DB) period (week 0 to week 48) on FSHD-Composite Outcome Measure (FSHD-COM) total score, sub-scale scores and individual items.

The study will evaluate the efficacy of satralizumab compared to placebo, measured by the change during the Double Blind (DB) period (week 0 to week 48) on FSHD-Rasch-built overall disability scale (FSHD-RODS) total score

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Secondary outcome measures

The study will evaluate safety/tolerability of satralizumab versus placebo, measured by frequency of clinically significant changes from baseline in laboratory test, vital signs, and physical examination results during Double Blind and Open-label periods

The study will evaluate the efficacy of satralizumab compared to placebo, measured by the change during Double Blind (DB) and Open-label (OL) periods (week 0 to week 96) on FSHD-Rasch-built overall disability scale (FSHD-RODS) total score

The study will evaluate the efficacy of satralizumab compared to placebo, measured by the change during Double Blind (DB) and Open-label (OL) periods (week 0 to week 96) on Neuromuscular Disease Independence Scale-Ambulatory (NMDIS-Amb) total score

+13 more

REINFORCE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group of patients who receive satralizumabExperimental Treatment1 Intervention

Group II: Group of patients who receive placeboPlacebo Group1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre Hospitalier Universitaire de NiceLead Sponsor

621 Previous Clinical Trials

176,812 Total Patients Enrolled

Frequently Asked Questions

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

Can individuals who have reached the age of 65 be considered as potential participants for this experiment?

"Candidates aged above 18 and below 65 years are eligible for recruitment in this study."

Answered by AI

Which individuals meet the eligibility criteria to participate in this scientific experiment?

"To be eligible for enrollment in this clinical trial, individuals must have a diagnosis of facioscapulohumeral muscular dystrophy and fall between the ages of 18 and 65. A total of 40 candidates will be accepted into the study."

Answered by AI

Are there any available slots for patients to participate in this research study?

"Apologies for the error. According to clinicaltrials.gov, this trial is currently not actively seeking participants. The initial posting was on January 1st, 2024, and the most recent update occurred on January 15th, 2024. However, I can provide information about other ongoing studies that are actively recruiting patients. Presently, there are a total of 93 studies enrolling participants at this time."

Answered by AI

What is the safety profile of satralizumab in individuals who are administered this medication?

"Based on the classification of this trial as Phase 2, our team at Power rates the safety of patients receiving satralizumab as a 2. While there is limited data supporting its safety, no evidence has been found to support its efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Efficacy and Safety of Satralizumab in FSHD1

2024. "Study to Evaluate the Efficacy and Safety of Satralizumab in FSHD1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06222827.

All > Muscular Dystrophy