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:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT03500328
Eligibility Criteria:
Inclusion Criteria:
* Aged 18-60 years
* Meets 2017 McDonald criteria for relapsing-remitting MS \[patients with clinically isolated syndrome (CIS) are not eligible\]
* Must be EITHER John Cunningham (JC) virus antibody negative or low positive (index antibody titer \<0.9), OR negative for: Hepatitis B and C, tuberculosis
* HIV negative
* No chemotherapy in past year; if patient has prior history of chemotherapy or malignancy, documentation in chart explaining why potential risks of higher-efficacy therapy are justified
Exclusion Criteria:
* Prior treatment with rituximab, ocrelizumab, ofatumumab, alemtuzumab, mitoxantrone or cladribine
* Prior treatment with any other MS DMT for more than 6 months
* Prior treatment with experimental aggressive therapies (e.g., T-cell vaccine, total lymphoid radiation, stem cells)
* Treatment with teriflunomide within past 2 years (even for ≤ 6 months), unless rapid wash out done (i.e., with cholestyramine or activated charcoal)
* Treatment in the past 6 months with any MS DMT
* Prior treatment with any other investigational immune-modulating /suppressing drug for MS not listed above
* Pregnant or breast-feeding
* Women of child-bearing age who are planning or strongly considering conception during the study time frame
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03500328
Study Brief:
Protocol Section:
NCT03500328