Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT02633033
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02633033
Study Brief:
Protocol Section:
NCT02633033