Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis

Phase 3

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: teriflunomide HMR1726; Drug: cholestyramine; Drug: charcoal

• Registration Number: NCT01863888
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

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.

Secondary Objectives:

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-05-23
• Study First Submitted QC: 2013-05-23
• Study First Posted: 2013-05-29
• Study Start: 2013-10
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
teriflunomide (HMR1726)	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.
teriflunomide (HMR1726)	cholestyramine	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.
teriflunomide (HMR1726)	charcoal	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Lymphocyte subset parameters as measured by flow cytometry	At 12 weeks and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in serum cytokine as measured by multicytokine array tool	At 12 weeks and 24 weeks
Change from baseline in Mitogen/TCR-specific T cell proliferation as measured by flow cytometry	At 12 weeks and 24 weeks
Change from baseline in biased T cell clonal repertoire based T cell receptor (TCR) spectratyping	At 12 weeks and 24 weeks

Trial Locations

Locations (10)

Investigational Site Number 056003; 🇧🇪 Sijsele-Damme, Belgium

Investigational Site Number 056002; 🇧🇪 Overpelt, Belgium

Investigational Site Number 276-002; 🇩🇪 Ulm, Germany

Investigational Site Number 276-003; 🇩🇪 Bad Mergentheim, Germany

Investigational Site Number 276-004; 🇩🇪 Hannover, Germany

Investigational Site Number 528001; 🇳🇱 Sittard-Geleen, Netherlands

Investigational Site Number 276-007; 🇩🇪 Mönchengladbach, Germany

Investigational Site Number 056001; 🇧🇪 Brussels, Belgium

Investigational Site Number 276-005; 🇩🇪 Marburg, Germany

Investigational Site Number 276-001; 🇩🇪 Münster, Germany