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 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT01228266
Eligibility Criteria:
Inclusion Criteria:
1. Inflammatory forms of MS
1. Relapsing-remitting MS (RRMS) patients
2. Secondary progressive MS (SPMS) patients with continued relapses
3. Primary progressive MS (PPMS) patients with enhancing MRI lesions and positive CSF (oligoclonal banding)
2. Age 18-50 years
3. Disease duration \>= 2 and \>= 10 years
4. EDSS 3.0 - 6.5
5. Progression, continued relapses or worsening MRI after at least a year of attempted therapy evidenced by:
1. Increase of \>= 1 EDSS point (if baseline EDSS \<= 5.0) or 0.5 EDSS points (if baseline EDSS \>= 5.5), or quantifiable, objective evidence of equivalent progression
2. \>= 1 moderate-severe relapses in past 18 months
3. \>= 1 Gadolinium enhancing lesions (double or triple dose Gadolinium)
4. \>= 1 new T2 lesion
5. For PPMS only, \>= 1 Gadolinium enhancing lesions
6. Has given informed consent to participate in the study.
Exclusion Criteria:
1. SPMS without ongoing relapses
2. PPMS without positive CSF or Gadolinium enhancing lesions
3. \<= 3 months since treatment with any immunosuppressive therapy
4. \<=1 month since last treatment with interferon-B or glatiramer acetate
5. Corticosteroid treatment \<= 30 days
6. Relapse \<= 60 days
7. History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C
8. Any metallic or electronic device that precludes from undergoing MRI
9. Pregnancy or lactation
10. Current treatment with an investigational therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01228266
Study Brief:
Protocol Section:
NCT01228266