Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatments interferon β-1a, teriflunomide
Phase phase 3
Sponsor Sanofi
Start date April 2009
End date September 2011
Trial size 324 participants
Trial identifier NCT00883337, 2008-006226-34, EFC10891

Summary

Primary objective was to assess the effectiveness evaluated by the time to failure of two doses of teriflunomide in comparison to interferon beta-1a in patients with relapsing Multiple Sclerosis [MS].

Secondary objectives were:

- To assess the effect of the two doses in comparison to interferon beta-1a on:

- Frequency of relapses,

- Fatigue,

- Patient's satisfaction with treatment.

- To evaluate the safety and tolerability of the two doses in comparison to interferon beta-1a.

The study consisted of a core treatment period with a common end date defined as 48 weeks after randomization of the last participant, followed by an optional long-term extension treatment period until teriflunomide is commercially available in accordance with local regulations.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Teriflunomide 7 mg once daily (core treatment period), then optional, Teriflunomide 14 mg once daily (extension treatment period).
teriflunomide HMR1726
Film-coated tablet Oral administration
(Experimental)
Teriflunomide 14 mg once daily (core treatment period), then optional, Teriflunomide 14 mg once daily (extension treatment period).
teriflunomide HMR1726
Film-coated tablet Oral administration
(Active Comparator)
Interferon β-1a 3 times a week (core treatment period), then optional, Teriflunomide 14 mg once daily (extension treatment period).
interferon β-1a Rebif®
Sterile preservative-free solution packaged in graduated pre-filled syringes Subcutaneous injection Ascending doses from 8.8 to 44 mcg according to local standard for Rebif®
teriflunomide HMR1726
Film-coated tablet Oral administration

Primary Outcomes

Measure
Overview of Failures
time frame: Core treatment period between 48 and 118 weeks depending on when the participant was enrolled
Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints
time frame: Core treatment period between 48 and 118 weeks depending on when the participant was enrolled

Secondary Outcomes

Measure
Annualized Relapse Rate [ARR]: Poisson Regression Estimates
time frame: Core treatment period between 48 and 118 weeks depending on when the participant was enrolled
Change From Baseline in Fatigue Impact Scale (FIS) Total Score
time frame: baseline (before randomization) and 48 weeks
Treatment Satisfaction Questionnaire for Medication [TSQM] Scores
time frame: 48 weeks
Overview of Adverse Events [AE]
time frame: from first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Relapsing form of MS meeting McDonald's criteria for MS diagnosis and Expanded Disability Status Scale [EDSS] score ≤5.5 at screening visit. Exclusion Criteria: - Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia; - Persistent significant or severe infection; - Liver function impairment or known history of hepatitis; - Use of adrenocorticotrophic hormone [ACTH] or systemic corticosteroids for 2 weeks prior to randomization; - Human immunodeficiency virus [HIV] positive; - Prior use of Rebif®, or prior or concomitant use of other interferons in the 3 months prior to randomization; - Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, or natalizumab; - Pregnant or breast-feeding woman; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Additional Information

Official title A Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis Plus a Long Term Extension Period
Description The core treatment period per participant was variable depending on the enrollment in the study (maximum of approximatively 118 weeks). The two doses of teriflunomide were administered in double-blind fashion, whereas interferon beta-1a (Rebif®) was open-label. The opportunity to continue with the highest dose of teriflunomide in open-label fashion was offered to the participants who successfully completed treatment in the core study. The overall treatment period was followed by a 4-week elimination follow-up period.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Sanofi.