Observational Registry of H.P. Acthar® Gel for Multiple Sclerosis Relapse
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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.
Condition or disease
Multiple Sclerosis, Relapsing-Remitting
Drug: H.P. Acthar® Gel (repository corticotropin injection)
H.P. Acthar Gel (repository corticotropin injection) contains a porcine analogue of adrenocorticotropic hormone (ACTH) for intramuscular or subcutaneous use. H.P. Acthar Gel (Acthar Gel) was initially approved by the FDA in 1952 and has multiple indications of use. This registry will evaluate the use of Acthar Gel for the treatment of exacerbations of multiple sclerosis (MS) in the US.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adult patients with a relapsing form of MS who initiate treatment with Acthar Gel for an MS exacerbation
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.
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.