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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT01695434
Eligibility Criteria:
Inclusion Criteria:
* MS patients diagnosed with clinically definite MS according to the McDonald criteria (Polman et al., 2005)
* Being on GA monotherapy (20mg/day sc) for at least 24 months prior to the 24-month MRI scan
* Having baseline clinical MRI scan that included SWI-filtered phase imaging in a 12-month window from the start day of the of the GA (MS patients)
* Having baseline clinical MRI scan that included SWI-filtered phase imaging (healthy controls)
* MS patients having a RR disease course (Lublin and Reingold, 1996)
* Age 18-65 (healthy controls will be matched to MS patients for age and sex)
* Signed informed consent at the 24-month follow-up
* Pass MRI health screening
* MS patients passing contrast screening
* MS patients having normal kidney function (creatinine clearance \>59)
* None of the exclusion criteria
Exclusion Criteria:
* Patients who had a relapse within 30 days prior to MRI baseline scan date
* Patients who received steroid treatment within 30 days prior to the MRI baseline scan date
* Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study
* MS patients who used other imunomodulatory or immunosuppressant treatment other than GA during the follow-up (e.g., IFN-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
* MS patients having abnormal kidney function (creatinine clearance \<59)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01695434
Study Brief:
Protocol Section:
NCT01695434