Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis (TERI-DYNAMIC)
To measure the effect of Teriflunomide on lymphocytes subsets in patients with relapsing forms of multiple sclerosis as compared with baseline values and those of a reference population of untreated healthy subjects.
To assess if Teriflunomide treatment results in biased T cell clonal diversity. To assess the effect of Teriflunomide on the function of peripheral blood mononuclear cells (proliferation and cytokine production in situ).
To assess the circulating cytokines profile in the serum of Relapsing Multiple Sclerosis (RMS) patients during a 24-week treatment versus baseline and healthy controls.
To assess the reversibility of all parameter changes in patients who discontinue treatment after accelerated elimination procedure with cholestyramine or activated charcoal.
Drug: teriflunomide HMR1726
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis|
- Change from baseline in Lymphocyte subset parameters as measured by flow cytometry [ Time Frame: At 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
- Change from baseline in biased T cell clonal repertoire based T cell receptor (TCR) spectratyping [ Time Frame: At 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
- Change from baseline in serum cytokine as measured by multicytokine array tool [ Time Frame: At 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Mitogen/TCR-specific T cell proliferation as measured by flow cytometry [ Time Frame: At 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: teriflunomide (HMR1726)
Participants administered 14mg Teriflunomide once daily, oral. For participants who permanently discontinue Teriflunomide, an accelerated elimination procedure with either cholestyramine or charcoal will be administered.
Drug: teriflunomide HMR1726
Pharmaceutical form:tablet Route of administration: oralDrug: cholestyramine
Pharmaceutical form:powder Route of administration: oralDrug: charcoal
Pharmaceutical form:granule Route of administration: oral
No Intervention: Reference population
Untreated healthy subjects
The duration of the study for patients is 32 weeks which includes 4 weeks for screening, 24 weeks for treatment and 4 weeks for follow-up. An extension of the study is proposed until Teriflunomide is commercially available in the country where patient lives.
The duration of the study for healthy volunteers is 25 weeks which includes only one week for screening.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01863888
|Investigational Site Number 056001|
|Brussels, Belgium, 1070|
|Investigational Site Number 056002|
|Overpelt, Belgium, 3900|
|Investigational Site Number 056003|
|Sijsele-Damme, Belgium, 8340|
|Investigational Site Number 276-003|
|Bad Mergentheim, Germany, 97980|
|Investigational Site Number 276-004|
|Hannover, Germany, 30625|
|Investigational Site Number 276-005|
|Marburg, Germany, 35043|
|Investigational Site Number 276-007|
|Mönchengladbach, Germany, 41061|
|Investigational Site Number 276-001|
|Münster, Germany, 48149|
|Investigational Site Number 276-002|
|Ulm, Germany, 89073|
|Investigational Site Number 528001|
|Sittard-Geleen, Netherlands, 6162BG|
|Study Director:||Clinical Sciences & Operations||Sanofi|