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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT02239393
Eligibility Criteria:
Inclusion Criteria:
* 1\) Males and females with a diagnosis of MS
1. Relapsing remitting MS (RRMS) not responding to at least 1 year of attempted therapy with one or more of the approved therapies (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, fingolimod, dimethyl fumarate, teriflunomide, alemtuzumab) as evidenced by at least one of the following:
* i) ≥1 clinically documented relapse in past 12 months
* ii) ≥2 clinically documented relapses in past 24 months
* iii) ≥1 gadolinium-enhancing lesion (GEL) at MRI performed within the past 12 months
2. 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, dimethylfumarate, teriflunomide, alemtuzumab) as evidenced by both:
* 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 past 12 months
* ii) ≥1 clinically documented relapse or ≥ 1 gadolinium-enhancing lesion (GEL) at MRI within the past 12 months
3. 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 past 12 months
* ii) ≥ 1 gadolinium-enhancing lesion (GEL) at MRI performed within the past 12 months
* iii) positive cerebrospinal fluid (CSF) (oligoclonal banding)
* 2\) Age 18 to 50 years old, inclusive at time of informed consent
* 3\) Disease duration 2 to 15 years (inclusive)
* 4\) EDSS 2.5 to 6.5
* 5\) Able and willing to sign informed consent prior to any study-related activities
Exclusion Criteria:
* 1\) RRMS not fulfilling inclusion criteria
* 2\) SPMS not fulfilling inclusion criteria
* 3\) PPMS not fulfilling inclusion criteria
* 4\) A history of active or chronic infection including infection with HIV1-2, chronic Hepatitis B or Hepatitis C
* 5\) Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization
* 6\) Previous treatment with cladribine or alemtuzumab
* 7\) Treatment with interferon-beta, glatiramer acetate, teriflunomide or dimethyl fumarate within the 30 days prior to randomization (all teriflunomide patients will be required to have followed a wash-out with either cholestyramine or activated charcoal as indicated in the product monograph)
* 8\) Treatment with corticosteroids within the 30 days prior to randomization
* 9\) Relapse occurred during the 60 days prior to randomization
* 10\) Previous history of a malignancy (patient reported) other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year
* 11\) Severely limited life expectancy by any other co-morbid illness
* 12\) History of previous diagnosis of myelodysplasia or previous hematologic disease (patient reported) or current clinically relevant abnormalities of white blood cell counts
* 13\) Pregnancy or risk of pregnancy (this includes participants that are not willing to practice active contraception for the duration of the study)
* 14\) eGFR \< 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination
* 15\) Known allergy to gentamicin or related aminoglycosides
* 16\) Inability to give written informed consent in accordance with research ethics board guidelines
* 17\) Concomitant participation in another clinical trial
* 18\) Inability to adhere to protocol according to the investigator's medical judgement
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02239393
Study Brief:
Protocol Section:
NCT02239393