CLINICAL TRIALS PROFILE FOR TERIFLUNOMIDE

All Clinical Trials for Teriflunomide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00134563 ↗	Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis	Completed	Sanofi	Phase 3	2004-09-01	The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS). Secondary objectives were: - to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale [EDSS], the burden of disease as measured by Magnetic Resonance Imaging [MRI] and patient-reported fatigue; - to evaluate the safety and tolerability of teriflunomide.
NCT00228163 ↗	Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses	Completed	Sanofi	Phase 2	2002-01-01	The primary objective is to assess the long-term safety of teriflunomide in multiple sclerosis subjects. The secondary objective is to assess the long-term efficacy.
NCT00475865 ↗	Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis	Completed	Sanofi	Phase 2	2007-04-01	The primary objective was to estimate the tolerability and safety of 2 doses of Teriflunomide administered once daily for 24 weeks, compared to placebo, in patients with multiple sclerosis [MS] with relapses who were on a stable dose of Glatiramer Acetate [GA]. The secondary objectives were: - to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in combination with a stable dose of GA on Magnetic Resonance Imaging [MRI] parameters, relapse rate and patient-reported fatigue; - to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of GA.
NCT00489489 ↗	Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis	Completed	Sanofi	Phase 2	2007-05-01	The primary objective was to estimate the tolerability and safety of 2 doses of teriflunomide administered once daily for 24 weeks, compared with placebo, in patients with multiple sclerosis [MS] with relapses who were on a stable dose of interferon-β [IFN-β]. Secondary objectives were: - to estimate the effects of the 2 doses of teriflunomide, compared to placebo, in combination with a stable dose of IFN-β on Magnetic Resonance Imaging [MRI] parameters, relapse rate and patient-reported fatigue; - to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of IFN-β.
NCT00622700 ↗	Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis	Completed	Sanofi	Phase 3	2008-02-01	The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS). The secondary objectives were: - To demonstrate the effect of teriflunomide, in comparison to placebo, on: - Reducing conversion to definite multiple sclerosis (DMS) - Reducing annualized relapse rate (ARR) - Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI) - Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS) - Proportion of disability-free participants as assessed by the EDSS - Reducing participant-reported fatigue - To evaluate the safety and tolerability of teriflunomide - To evaluate the pharmacokinetics (PK) of teriflunomide - Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes
NCT00751881 ↗	An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis	Completed	Sanofi	Phase 3	2008-08-01	The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS. Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression. Other secondary objectives were: - To assess the effect of the two doses of teriflunomide in comparison to placebo on: - Fatigue; - Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being. - To evaluate the safety and tolerability of teriflunomide.

Clinical Trial Conditions for Teriflunomide

Condition Name

Condition Name for Teriflunomide
Intervention	Trials
Multiple Sclerosis	25
Relapsing Multiple Sclerosis	10
Immune Thrombocytopenia	3
Relapsing Multiple Sclerosis (RMS)	2

Condition MeSH

Condition MeSH for Teriflunomide
Intervention	Trials
Multiple Sclerosis	43
Sclerosis	40
Multiple Sclerosis, Relapsing-Remitting	4
Thrombocytopenia	3

Clinical Trial Locations for Teriflunomide

Trials by Country

Trials by Country for Teriflunomide
Location	Trials
United States	342
Canada	41
Spain	36
Italy	34
Germany	25

Trials by US State

Trials by US State for Teriflunomide
Location	Trials
Florida	20
California	17
Ohio	17
Michigan	15
Indiana	14

Clinical Trial Progress for Teriflunomide

Clinical Trial Phase

Clinical Trial Phase for Teriflunomide
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	26
Phase 2	10

Clinical Trial Status

Clinical Trial Status for Teriflunomide
Clinical Trial Phase	Trials
Completed	24
Recruiting	17
Active, not recruiting	8

Clinical Trial Sponsors for Teriflunomide

Sponsor Name

Sponsor Name for Teriflunomide
Sponsor	Trials
Sanofi	21
Novartis Pharmaceuticals	5
National Cancer Institute (NCI)	4

Sponsor Type

Sponsor Type for Teriflunomide
Sponsor	Trials
Industry	42
Other	41
NIH	5