Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
Relapsing, Remitting Multiple Sclerosis, RRMS
Brief summary
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).
Interventions
DRUGActhar Gel
Acthar Gel 1 mL (80U) for subcutaneous injection
DRUGPlacebo
Placebo for subcutaneous injection
Sponsors
Mallinckrodt ARD LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
While Care Provider and Outcomes Assessor were also blinded, it was considered a double-blind study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42 | Baseline, 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. |
Countries
United States
Participant flow
Recruitment details
The study was terminated early by sponsor decision because of recruitment difficulties and the impact of the COVID-19 pandemic.
Pre-assignment details
Approximately 66 participants were planned at 25 sites; while only 35 were randomized using 31 sites, because of recruitment difficulties and the impact of the COVID-19 pandemic.
Participants by arm
| Arm | Count |
|---|---|
| Acthar Gel Participants receive Acthar Gel under the skin once a day for 14 consecutive days | 18 |
| Placebo Participants receive Placebo under the skin once a day for 14 consecutive days | 17 |
| Total | 35 |
Baseline characteristics
| Characteristic | Acthar Gel | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 40 years | 43 years | 40 years |
| Age, Customized Adults 21-64 ≤35 | 4 Participants | 6 Participants | 10 Participants |
| Age, Customized Adults 21-64 36-45 | 10 Participants | 6 Participants | 16 Participants |
| Age, Customized Adults 21-64 46-55 | 2 Participants | 2 Participants | 4 Participants |
| Age, Customized Adults 21-64 56-64 | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 16 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 15 Participants | 30 Participants |
| Region of Enrollment United States | 18 participants | 17 participants | 35 participants |
| Sex: Female, Male Female | 15 Participants | 12 Participants | 27 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 17 |
| other Total, other adverse events | 14 / 18 | 12 / 17 |
| serious Total, serious adverse events | 0 / 18 | 0 / 17 |
Outcome results
Primary
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.
Time frame: Baseline, Day 42
Population: modified Intent to Treat (mITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acthar Gel | Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42 | Baseline | 3.86 score on a scale | Standard Deviation 1.122 |
| Acthar Gel | Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42 | Day 42 | 2.92 score on a scale | Standard Deviation 0.974 |
| Placebo | Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42 | Baseline | 3.85 score on a scale | Standard Deviation 1.169 |
| Placebo | Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42 | Day 42 | 3.62 score on a scale | Standard Deviation 1.485 |