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Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00489489 |
The primary objective of this study is to estimate the tolerability and safety of 2 doses of teriflunomide administered once daily for 24 weeks, compared with placebo, in subjects with multiple sclerosis who are currently on a stable dose of interferon-β.
Condition | Intervention | Phase |
---|---|---|
Multiple Sclerosis |
Drug: teriflunomide (HMR1726) Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Randomized, Multinational, Double-Blind, Placebo-Controlled, Parallel-Group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Interferon-Beta in Subjects With Multiple Sclerosis. |
Estimated Enrollment: | 120 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
7 mg
|
Drug: teriflunomide (HMR1726)
in combination with a stable dose of Interferon-β
|
2: Experimental
14 mg
|
Drug: teriflunomide (HMR1726)
in combination with a stable dose of Interferon-β
|
3: Placebo Comparator |
Drug: placebo
in combination with a stable dose of Interferon-β
|
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
United States, New Jersey | |
Sanofi-Aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 | |
Canada | |
Sanofi-Aventis Administrative Office | |
Laval, Canada | |
Germany | |
Sanofi-Aventis Administrative Office | |
Berlin, Germany | |
Italy | |
Sanofi-Aventis Administrative Office | |
Milan, Italy | |
Spain | |
Sanofi-Aventis Administrative Office | |
Barcelona, Spain |
Study Director: | ICD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | PDY6045, EudraCT 2006-003134-14, HMR1726D-2003, LTS6047 |
Study First Received: | June 20, 2007 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00489489 |
Health Authority: | Canada: Health Canada; Germany: Paul-Ehrlich-Institut; Spain: Spanish Agency of Medicines |
MS interferon-beta adjunctive therapy relapses |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Interferons Interferon-beta |
Demyelinating Autoimmune Diseases, CNS Demyelinating diseases Sclerosis Autoimmune Diseases of the Nervous System |
Anti-Infective Agents Pathologic Processes Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Antiviral Agents Pharmacologic Actions |