Observational Registry of H.P. Acthar® Gel for Multiple Sclerosis Relapse
Status: | Active, not recruiting |
---|---|
Conditions: | Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/27/2019 |
Start Date: | November 24, 2015 |
End Date: | May 2019 |
A Prospective Observational Registry of H.P. Acthar® Gel for the Treatment of Multiple Sclerosis Relapse
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.
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.
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.
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.
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.
We found this trial at
41
sites
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