Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis
NCT ID: NCT00489489
Last Updated: 2012-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
118 participants
INTERVENTIONAL
2007-05-31
2009-06-30
Brief Summary
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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.
Detailed Description
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* Screening period up to 4 weeks,
* 24-week double-blind treatment period\*,
* 16-week post-treatment elimination follow-up period.
'\*' participants successfully completing the week 24 visit were offered the opportunity to enter the optional long-term extension study LTS6047 - NCT00811395.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Teriflunomide 7 mg + IFN-β
Teriflunomide 7 mg once daily concomitantly with Interferon-β (IFN-β) for 24 weeks
Teriflunomide
Film-coated tablet
Oral administration
Interferon-β
Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
Teriflunomide 14 mg + IFN-β
Teriflunomide 14 mg once daily concomitantly with Interferon-β (IFN-β) for 24 weeks
Teriflunomide
Film-coated tablet
Oral administration
Interferon-β
Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
Placebo + IFN-β
Placebo (for Teriflunomide) once daily concomitantly with Interferon-β (IFN-β) for 24 weeks
Placebo (for Teriflunomide)
Film-coated tablet
Oral administration
Interferon-β
Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
Interventions
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Teriflunomide
Film-coated tablet
Oral administration
Placebo (for Teriflunomide)
Film-coated tablet
Oral administration
Interferon-β
Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Relapsing clinical course, with or without progression;
* Expanded Disability Status Scale \[EDSS\] less or equal to 5.5 (ambulatory);
* Stable dose of IFN-β for at least 26 weeks prior to the screening visit;
* No onset of MS relapse in the preceding 60 days prior to randomization;
* Clinically stable for 4 weeks prior to randomization.
Exclusion Criteria
* Pregnant or nursing woman;
* Alcohol or drug abuse;
* Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
* Human immunodeficiency virus \[HIV\] positive status;
* Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
55 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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ICD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Laval, , Canada
Sanofi-Aventis Administrative Office
Berlin, , Germany
Sanofi-Aventis Administrative Office
Milan, , Italy
Sanofi-Aventis Administrative Office
Barcelona, , Spain
Countries
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References
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Freedman MS, Wolinsky JS, Wamil B, Confavreux C, Comi G, Kappos L, Olsson TP, Miller A, Benzerdjeb H, Li H, Simonson C, O'Connor PW; Teriflunomide Multiple Sclerosis Trial Group and the MRI Analysis Center. Teriflunomide added to interferon-beta in relapsing multiple sclerosis: a randomized phase II trial. Neurology. 2012 Jun 5;78(23):1877-85. doi: 10.1212/WNL.0b013e318258f7d4. Epub 2012 May 23.
Other Identifiers
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2006-003134-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HMR1726D-2003
Identifier Type: OTHER
Identifier Source: secondary_id
PDY6045
Identifier Type: -
Identifier Source: org_study_id