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

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ohio State University; OhioHealth
• Treatments: Adrenocorticotropic Hormone

Criteria

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.