Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)

Study Overview
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Brief Summary
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This study will enroll about 66 participants who experienced a relapse of RRMS that steroids did not help. The doctor will put participants into a treatment group. Each person has an equal chance of being in either one of two groups (like flipping a coin). One group will receive a shot of study medicine (called Acthar Gel) under their skin every day for 14 days. The other group will receive a shot every day for 14 days, too, but there is no medicine in it (called placebo).

Official Title
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A Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of Acthar® in Subjects With Relapsing-remitting Multiple Sclerosis

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Drug: Acthar Gel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Had a clinical diagnosis of relapsing-remitting multiple sclerosis (RRMS) Had a relapse with onset ≤42 days prior to the Baseline Visit Had started treatment with 3 to 5 days (inclusive, over a period of up to 7 days) of specific high dose corticosteroids within 28 days of the onset of the first relapse symptom Had failed to obtain improvement of at least 1 point in one or more functions on the Function Systems Score (FSS) 14 days following their first dose of high dose corticosteroids Has an Expanded Disability Index Scale (EDSS) score of 2.0 to 6.5 (inclusive) at the Baseline Visit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acthar Gel<br>Participants receive Acthar Gel under the skin once a day for 14 consecutive days | Drug: Acthar Gel<br>* Acthar Gel 1 mL (80U) for subcutaneous injection<br>* Other names: Repository Corticotropin Injection;|
| Placebo Comparator: Placebo<br>Participants receive Placebo under the skin once a day for 14 consecutive days | Drug: Placebo<br>* Placebo for subcutaneous injection<br>* Other names: Matching Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42 | The EDSS is a 10-point assessment of neurological impairment/disability in multiple sclerosis (MS) patients, ranging from 0 (normal neurological examination) to 10 (death due to MS). EDSS is rated by a person who only collects outcome measures, and has no knowledge of the treatment received. | Baseline, Day 42 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsing, Remitting Multiple Sclerosis, RRMS