Status:
COMPLETED
Mechanistic Studies of Teriflunomide in RRMS
Lead Sponsor:
University of Michigan
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Brief Summary
This study is to address the mechanism of action of teriflunomide in a phase IV open label trial with Teriflunomide in multiple sclerosis. Researchers will recruit 20 relapsing remitting multiple scle...
Detailed Description
Multiple sclerosis is the most common autoimmune inflammatory and debilitating chronic demyelinating disease of the central nervous system mainly affecting young adults. There is a tremendous need to ...
Eligibility Criteria
Inclusion
- Patients with clinically-defined relapsing-remitting MS (RRMS) who " are newly starting on teriflunomide (AubagioTM) at the time of enrollment " have no evidence of relapse or corticosteroid treatment use within 2 months prior to enrollment
- OR
- Healthy controls who do not have a significant medical condition such as cancer, chronic infection, or autoimmune disease, have not taken steroids in the past 2 months, and who are not on an immune suppressant medication.
- Ability to give informed consent
- Willing to have blood drawn as scheduled in the protocol
- Willing and able to complete all procedures and evaluations related to the study
Exclusion
- Medical or psychiatric conditions that may affect the patient's ability to give informed consent
- Has received an experimental drug within 30 days of enrollment
- Concomitant other disease modifying medications (such as Rebif, Betaseron, Avonex, Copaxone, Gilenya, Tecfidera, Alemtuzumab, methotrexate, azathioprine, mitoxantrone, cyclophosphamide, cyclosporine, natalizumab, rituxan, ocrelizumab, etc.) without the minimal washout period stated below:
- " rebif, betaseron, avonex, copaxone within 1 month " zinbryta, plegridy, gilenya, tecfidera within 2 months " natalizumab within 3 months " immunosuppressive/chemotherapeutic medications (e.g. azathioprine, methotrexate) within 6 months " cyclophosphamide within 1 year " rituximab, ofatumumab, ocrelizumab, cladribine within 1 year " alemtuzumab at any time " any mitoxantrone during previous 2 years prior to randomization or evidence of cardiotoxicity following mitoxantrone or a cumulative life-time dose of more than 60 mg/m2 " lymphoid irradiation, bone marrow transplantation or other immunosuppressive treatments with effects potentially lasting over 6 months, at any time
- Has any contraindication to high-dose immunotherapy, including pregnancy, trying to become pregnant, or breast feeding during the study.
Key Trial Info
Start Date :
April 17 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 13 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03464448
Start Date
April 17 2018
End Date
October 13 2021
Last Update
December 27 2022
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109