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Biomarkers and Disease Activity in Patients Treated With Teriflunomide (Aubagio)

NCT03561402 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2021-03-24

No results posted yet for this study

Summary

The study is a two-year prospective observational study of patients treated with teriflunomide. The investigators will recruit up to 75 patients at baseline, based on the estimate that approximately 20% of these patients (\~ 15 patients) will have evidence of disease activity at the end of the first year of treatment with teriflunomide, as determined by clinical evaluation (relapses) and MRI activity (new T2 hyperintense lesions). The investigators will assess the expression of a putative biomarker signature consisting of toll like receptor 2(TLR2), TLR4 and chemokine receptor 1 (CCR1) on CD4 T-subsets at baseline and at intervals on treatment with teriflunomide to determine whether expression of this biomarker signature on one or more CD4 T-subsets correlates with disease activity.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

DRUG

Teriflunomide

Each patient will receive 1 tablet (14 mg) on a daily basis.

Sponsors & Collaborators

Principal Investigators

  • David Haegert, MD · McGill University

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-01
Primary Completion
2020-12-30
Completion
2020-12-30
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03561402 on ClinicalTrials.gov