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:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT01945359
Eligibility Criteria:
Inclusion Criteria:
1. JCV Indec of 1.5 of greater and currently receiving natalizumab therapy for at least 24 months
2. Decision to treat with DMF must precede enrollment
3. Ability to understand the purpose and risk of the study and provide authorization for the use of protected health information in accordance with the monitoring agency
4. Men or women \>= 18 years at time of informed consent
5. Naive to DMF or fumaric acid esters
6. Confirmed diagnosis of a relapsing form of MS as verified by their treating physician
Exclusion Criteria:
1. Inability ot comply with study requirements as outlined in the informed consent
2. Known active malignancies or any other major co morbidity that, in the opinion of the Investigator, would affect the outcome of the study
3. Pregnancy or breastfeeding
4. Previous treatment with dimethyl fumarate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01945359
Study Brief:
Protocol Section:
NCT01945359