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

Purpose

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).

Condition

  • Multiple Sclerosis, Relapsing-Remitting

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
While Care Provider and Outcomes Assessor were also blinded, it was considered a double-blind study.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Acthar Gel
Participants receive Acthar Gel under the skin once a day for 14 consecutive days
  • Drug: Acthar Gel
    Acthar Gel 1 mL (80U) for subcutaneous injection
    Other names:
    • Repository Corticotropin Injection
Placebo Comparator
Placebo
Participants receive Placebo under the skin once a day for 14 consecutive days
  • Drug: Placebo
    Placebo for subcutaneous injection
    Other names:
    • Matching Placebo

More Details

Status
Terminated
Sponsor
Mallinckrodt ARD LLC

Study Contact