Observational Registry of H.P. Acthar® Gel for Multiple Sclerosis Relapse

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 260
• Participant gender: Both

Summary

This observational study aims to characterize the patient population and describe multiple sclerosis exacerbation recovery, treatment patterns and safety outcomes in patients with multiple sclerosis experiencing exacerbations treated with H.P. Acthar® Gel (Acthar Gel) in standard practice in the United States.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt
• Treatments: Adrenocorticotropic Hormone
• Last Updated: 2016-08-09

Criteria

Inclusion Criteria:

1. Male or Female ≥ 18 years of age.

2. Patient has a clinically definite relapsing form of Multiple Sclerosis according to McDonald Criteria (2010 revision).

3. Patient with an acute MS exacerbation as determined by their treating clinician.

4. Patient planning to initiate Acthar Gel for the treatment of an acute MS exacerbation.

5. Patient capable of providing informed consent.

Exclusion Criteria:

1. Patients with a diagnosis of Progressive MS.

2. Patients that require concomitant corticosteroid therapy.

3. Patients receiving experimental drug therapy.

4. Patients with a history of scleroderma, systemic fungal infections, ocular herpes simplex, or cancer within prior 5 years.

5. Patients who had recent surgery or have a history of or the presence of a peptic ulcer within 6 months prior to study entry, congestive heart failure, or sensitivity to proteins of porcine origin.

6. If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control.