Mechanistic Studies of Teriflunomide in RRMS

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2023
• Main ID: NCT03464448
• Date of registration: 07/03/2018
• Prospective Registration: Yes
• Primary sponsor: University of Michigan
• Public title: Mechanistic Studies of Teriflunomide in RRMS
• Scientific title: Mechanistic Studies of Teriflunomide in Relapsing Remitting Multiple Sclerosis: Regulatory B Lymphocytes as Central Mediators of the Therapeutic Effects of Teriflunomide in MS
• Date of first enrolment: April 17, 2018
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03464448
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Yang Mao-Draayer, MD/PHD
• Affiliation: University of Michigan

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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.

2. Ability to give informed consent

3. Willing to have blood drawn as scheduled in the protocol

4. Willing and able to complete all procedures and evaluations related to the study

Exclusion Criteria:

1. Medical or psychiatric conditions that may affect the patient's ability to give
informed consent

2. Has received an experimental drug within 30 days of enrollment

3. 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

4. Has any contraindication to high-dose immunotherapy, including pregnancy, trying to
become pregnant, or breast feeding during the study.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis

Intervention(s)

Drug: Teriflunomide

Primary Outcome(s)

Changes in frequency of regulatory and effector B cell subset [Time Frame: From baseline to 6 months and 12 months]

Secondary Outcome(s)

Change in frequency of CD4+ Th17, Th1, Th2, and Treg cells [Time Frame: From baseline to 6 months and 12 months]

Change in cytokine levels [Time Frame: From baseline to 6 months and 12 months]

Change in chemokine levels [Time Frame: From baseline to 6 months and 12 months]

Secondary ID(s)

HUM00136966

Source(s) of Monetary Support

Please refer to primary and secondary sponsors