Observational Registry of Acthar Gel for Participants With Multiple Sclerosis Relapse

Completed

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

Acthar Gel was first approved by the Food and Drug Administration in 1952. It has been used to treat many different illnesses, including multiple sclerosis. This study will observe how treatment with Acthar affected the daily lives of patients who suffer with relapsing/remitting MS. It will collect information on symptoms, recovery, treatment patterns and safety outcomes.

Key facts

Study ID

NCT02633033

Run by

Mallinckrodt

People needed

160

Starts

2015-11-24

Expected to finish

2019-05-09

Last updated by the study team

2019-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or Female ≥ 18 years of age.
• Patient has a clinically definite relapsing form of Multiple Sclerosis according to McDonald Criteria (2010 revision).
• Patient with an acute MS exacerbation as determined by their treating clinician.
• Patient planning to initiate Acthar Gel for the treatment of an acute MS exacerbation.
• Patient capable of providing informed consent.

You may not qualify if…

• Patients with a diagnosis of Progressive MS.
• Patients that require concomitant corticosteroid therapy.
• Patients receiving experimental drug therapy.
• Patients with a history of scleroderma, systemic fungal infections, ocular herpes simplex within prior 5 years.
• Patient has any solid tumor malignancy currently diagnosed or undergoing therapy, or has received therapy for any solid tumor malignancy in the 5 years prior to the Enrollment Visit, with the exception of treated and cured basal cell carcinoma, treated and cured squamous cell carcinoma of the skin, and treated and cured carcinoma in situ of the cervix.
• 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.
• If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control.

Where it is running

• Alabama Neurology Associates — Homewood, Alabama, United States
• Territory Neurology & Research Institute — Tucson, Arizona, United States
• Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States
• Advanced Neurosciences Research — Fort Collins, Colorado, United States
• Associated Neurologists of Southern Connecticut — Fairfield, Connecticut, United States
• MedStar Health — Washington D.C., District of Columbia, United States
• Emery Neuroscience Center — Lighthouse PT, Florida, United States
• Neurology Associates — Maitland, Florida, United States
• Cordova Research Institute — Miami, Florida, United States
• Collier Neurologic Specialists — Naples, Florida, United States
• Florida Neurological Center — Ocala, Florida, United States
• Neurological Services of Orlando — Orlando, Florida, United States
• Neurology Associates of Ormond Beach — Ormond Beach, Florida, United States
• Negroski, Sutherland and Hanes Neurology — Sarasota, Florida, United States
• Infinity Clinical Research — Sunrise, Florida, United States
• Columbus Research & Wellness Institute — Columbus, Georgia, United States
• Neurology of Central Georgia — Macon, Georgia, United States
• Meridian Clinical Research — Savannah, Georgia, United States
• College Park Family Care Center — Overland Park, Kansas, United States
• University System of Maryland — Baltimore, Maryland, United States
• International Neurorehabilitation Institute — Lutherville, Maryland, United States
• Neurology Center of New England — Foxborough, Massachusetts, United States
• Milford Regional Medical Center — Hopedale, Massachusetts, United States
• Detroit Clinical Research Center — Farmington Hills, Michigan, United States
• CentraState Medical Center — Freehold, New Jersey, United States

Full record on ClinicalTrials.gov

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