Observational Registry of Acthar Gel for Participants With Multiple Sclerosis Relapse

Mallinckrodt

Status: Completed

Conditions: Multiple Sclerosis, Relapsing-Remitting

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT02633033

MNK14130050

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 within prior 5 years.
5. 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.
6. 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.
7. If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control.