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Trial record 7 of 47 for:    teriflunomide

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

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ClinicalTrials.gov Identifier: NCT03561402
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
David Haegert, McGill University

Brief Summary:
The study is a two-year prospective observational study of patients treated with teriflunomide. We will recruit up to 75 patients at baseline, as we 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). We 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.

Condition or disease Intervention/treatment
Multiple Sclerosis, Relapsing-Remitting Drug: Teriflunomide

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Association of Possible Biomarkers With Disease Activity in Patients Treated With Teriflunomide (Aubagio)
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group with disease activity
The group will have evidence of disease activity on treatment with teriflunomide, as indicated by clinical criteria (relapses) or radiological criteria (new T2 weighted lesions)
Drug: Teriflunomide
Group with stable disease
The group will have no evidence of disease activity on treatment with teriflunomide, i.e. no evidence of relapses or new T2 weighted lesion.
Drug: Teriflunomide



Primary Outcome Measures :
  1. Expression levels of biomarkers on patients treated with teriflunomide [ Time Frame: 1 year ]
    Measurement of expression of TLR2, TLR4 and CCR1 by flow cytometry and Tob1 using quantitative RT-PCr and PrimeFlow RNA assay


Biospecimen Retention:   Samples With DNA
Cryopreserved peripheral blood mononuclear cells (PBMC)


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with relapsing-remitting MS who agree to be treated with teriflunomide
Criteria

Inclusion Criteria:

Treatment naive patients with relapsing-remitting multiple sclerosis and patients treated previously with one or more previous disease-modifying treatments but with a washout period of at least 4 weeks before starting treatment with teriflunomide.

Exclusion Criteria:

Acute infections in the preceding 4 weeks, vaccination in previous 2 months, an active malignancy (except basal cell carcinoma) pregnant or breastfeeding patients, communication difficulty, i.e. unable to understand the study, vulnerable patients, i.e. unable to consent or lacking legal freedom, e.g. prisoners.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561402


Contacts
Contact: David Haegert, MD 5149341934 ext 38777 david.haegert@muhc.mcgill.ca
Contact: Leslie Fitz-Gerald, MSc 5157930509 leslie.fitz-gerald@mail.mcgill.ca

Locations
Canada, Quebec
Department of Pathology Recruiting
Montréal, Quebec, Canada, H3A 2B4
Contact: David Haegert, MD         
Sponsors and Collaborators
McGill University
Investigators
Principal Investigator: David Haegert, MD McGill University

Responsible Party: David Haegert, Professor, McGill University
ClinicalTrials.gov Identifier: NCT03561402     History of Changes
Other Study ID Numbers: GZ-2015-11483
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Haegert, McGill University:
biomarker
teriflunomide
activity

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases