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 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT01854957
Eligibility Criteria:
Inclusion Criteria:
\- 1. Diagnosis of MS
a. Relapsing remitting MS (RRMS) not responding to at least a year of attempted therapy with one or more of the approved therapies (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, fingolimod) as evidenced by one or more of the following: i. ≥1 clinically documented relapse in past 12 months
ii. ≥2 clinically documented relapses in last 24 months
iii. ≥1 GEL at MRI performed within the last 12 months
b. Secondary progressive MS (SPMS) not responding to at least a year of attempted therapy with one or more of the approved therapies (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, fingolimod) as evidenced by both:
i. an increase of ≥1 point of the expanded disability status scale (EDSS) (if at randomization EDSS ≤ 5.0) or 0.5 EDSS point (if at randomization EDSS ≥ 5.5) in the last 12 months
ii. ≥1 clinically documented relapse or ≥ 1 GEL at MRI within the last twelve months.
c. Primary progressive MS (PPMS) patients with all the following features:
i. an increase of ≥1 EDSS point (if at randomization EDSS ≤ 5.0) or 0.5 EDSS point (if at randomization EDSS ≥5.5), in the last twelve months
ii. ≥ 1 GEL at MRI performed within the last 12 months
iii. positive cerebrospinal fluid (CSF) (oligoclonal banding
* 2\. Age 18 to 50 years
* 3\. Disease duration 2 to 10 years (included)
* 4\. EDSS 3.0 to 6.5
Exclusion Criteria:
* 1\. RRMS not fulfilling inclusion criteria
* 2\. SPMS not fulfilling inclusion criteria
* 3\. PPMS not fulfilling inclusion criteria
* 4\. Any active or chronic infection including infection with HIV1-2 or chronic Hepatitis B or Hepatitis C
* 5\. Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization
* 6\. Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization
* 7\. Treatment with corticosteroids within the 30 days prior to randomization
* 8\. Relapse occurred during the 60 days prior to randomization
* 9\. Previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year
* 10\. Severely limited life expectancy by another co-morbid illness
* 11\. History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts
* 12\. Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study)
* 13\. eGFR \< 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination.
* 14\. Inability to give written informed consent in accordance with research ethics board guidelines
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01854957
Study Brief:
Protocol Section:
NCT01854957