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 @ 11:45 AM
Ignite Modification Date:
2025-12-24 @ 11:45 AM
NCT ID:
NCT01684761
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with MS as defined by the modified McDonald criteria
* SPMS defined as relapsing-remitting disease with recent progression in MS-related neurological deficits
* EDSS score 3.0 - 6.0, inclusively
* Presence of myelin reactive T-cells
Exclusion Criteria:
* Diagnosed with primary progressive MS
* Treatment with beta-interferon, glatiramer acetate or dimethyl fumarate 30 days prior to screening
* Treatment with ACTH, any over-the-counter or prescription corticosteroids 60 days prior to screening
* Treatment with IVIG, plasmapheresis or cytopheresis 90 days prior to screening
* Treatment with mitoxantrone, teriflunomide, fingolimod, natalizumab, azathioprine, cyclosporine, methotrexate or mycophenolate mofetil 1 year prior to baseline
* Any prior treatment with cladribine, cyclophosphamide, total lymphoid irradiation, T cell or T cell receptor products, or any therapeutic monoclonal antibody, except natalizumab
* Previous treatment with any other MS investigational drug 1 year prior to screening
* All non-MS investigational drugs must have a minimum washout of 30 days prior to screening or 5 half-lives, whatever is the longest period of time.
* HIV or hepatitis infection
* History of cancer
* Any other significant medical condition that, in the opinion of the investigator, could cause CNS tissue damage or limit its repair.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01684761
Study Brief:
Protocol Section:
NCT01684761