Tolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS)

OhioHealth

Status: Completed

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: Acthar

Study type: Interventional

Funder types: Other

Identifiers

NCT02258217

2014H0156

Details and patient eligibility

About

Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)

Full description

We propose to conduct a prospective, single-center, open-label, single-arm study comparing tolerability of Acthar versus oral prednisone in the treatment of MS relapses. Potential subjects will be identified during routine clinical evaluations. If patient is determined to be having a study-defined MS relapse, they will be invited to participate in this study. After consent is obtained, the patient will complete the first page of the ARMS survey. If prior steroid use was deemed tolerable then only the first page of the ARMS will be collected and analyzed and these patients will complete their participation in the trial. Their data from the ARMS will provide an estimate as to the number of patients who self-report tolerability and efficacy issues with steroids. However, if patients self-report prior steroid intolerability, then they will advance into the Acthar treatment arm of the trial.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subjects who have volunteered and consented to participate in the study.
2. Subjects who have no contraindication to taking high dose, oral prednisone or Acthar.
3. Male or Female subjects age 18 or greater years of age.
4. Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) based on 2010 McDonald Criteria.
5. Subjects without an active infection (Note: If a patient is found to have an uncomplicated UTI and agrees to start on appropriate antibiotic treatment, they can continue in the study).
6. Subjects who are experiencing a protocol defined MS relapse within two weeks of relapse onset.
7. Subjects who are able and willing to sign a consent form.

Exclusion criteria

1. Subjects who are less than 18 years of age.
2. Subjects with any contraindication to taking Acthar.
3. Subjects with an active infection other than an uncomplicated urinary tract infection (UTI) (subjects determined to have a UTI who agree to be treated with appropriate antibiotics will not be excluded).
4. Subjects with an immune deficiency.
5. Subjects with a history of any of the following conditions: gastrointestinal ulcers, diabetes mellitus, gestational diabetes, malignant hypertension or steroid induced psychosis.
6. Subjects who are pregnant or breastfeeding.
7. Subjects who are unable or unwilling to sign consent form.
8. Patient is unable or unwilling to participate in phone and clinic follow up.
9. Other factors that in the opinion of the Principal Investigator would exclude the subject from participation in the study.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Single arm

Experimental group

Description:

Acthar 80 units subcutaneously for five consecutive days.

Treatment:

Drug: Acthar