Multiple Sclerosis Clinical Trial
Observational Registry of Acthar Gel for Participants With Multiple Sclerosis Relapse
Summary
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.
Full Description
Acthar Gel (repository corticotropin injection) contains a non-bovine analogue of adrenocorticotropic hormone (ACTH) for intramuscular or subcutaneous use.
It was initially approved by the FDA in 1952 and is used for multiple indications.
This registry will evaluate the use of Acthar Gel for the treatment of MS exacerbations in the United States.
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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There are 38 Locations for this study
Homewood Alabama, 35209, United States
Tucson Arizona, 85704, United States
Colorado Springs Colorado, 80907, United States
Fort Collins Colorado, 80528, United States
Fairfield Connecticut, 06824, United States
Washington District of Columbia, 20007, United States
Lighthouse Point Florida, 33064, United States
Maitland Florida, 32751, United States
Miami Florida, 33155, United States
Naples Florida, 34102, United States
Ocala Florida, 34471, United States
Orlando Florida, 32806, United States
Ormond Beach Florida, 32174, United States
Sarasota Florida, 34239, United States
Sunrise Florida, 33351, United States
Columbus Georgia, 31904, United States
Macon Georgia, 31210, United States
Savannah Georgia, 31406, United States
Overland Park Kansas, 66212, United States
Baltimore Maryland, 21201, United States
Lutherville Maryland, 21093, United States
Foxboro Massachusetts, 02035, United States
Hopedale Massachusetts, 01747, United States
Farmington Hills Michigan, 48334, United States
Freehold New Jersey, 07728, United States
New York New York, 11714, United States
Staten Island New York, 10306, United States
Woodmere New York, 11598, United States
Mooresville North Carolina, 28117, United States
Toledo Ohio, 43623, United States
Uniontown Ohio, 44685, United States
Bala-Cynwyd Pennsylvania, 19004, United States
Jamison Pennsylvania, 18929, United States
Lititz Pennsylvania, 17543, United States
West Reading Pennsylvania, 19610, United States
Sumter South Carolina, 29150, United States
Ogden Utah, 84403, United States
Richmond Virginia, 23226, United States
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