Phase 3
Completed N=324
A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis
Source: ClinicalTrials.gov NCT00883337 ↗Enrolled (actual)
324
Serious AEs
10.6%
Results posted
Nov 2012
Primary outcomePrimary: Core Treatment Period: Overview of Failures — 53; 42; 44; 56 participants
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 participants 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,
* Participant'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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Core Treatment Period: Overview of Failures |
53; 42; 44; 56; 69; 60 | — |
| PRIMARY Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints |
25.7; 24.3; 29.8; 35.8; 33.3; 36.5 | 0.5953 |
| SECONDARY Core Treatment Period: Annualized Relapse Rate [ARR] - Poisson Regression Estimates |
0.410; 0.259; 0.216 | — |
| SECONDARY Core Treatment Period: Change From Baseline in Fatigue Impact Scale (FIS) Total Score |
0.97; 4.10; 9.10 | — |
| SECONDARY Core Treatment Period: Treatment Satisfaction Questionnaire for Medication [TSQM] Scores |
67.25; 63.13; 59.30; 95.29; 93.15; 71.38 | — |
| SECONDARY Core Treatment Period: Overview of Adverse Events [AE] |
103; 102; 97; 12; 6; 7 | — |
| SECONDARY Extension Treatment Period: Overview of AEs |
83; 76; 48; 9; 13; 12 | — |
| SECONDARY Extension Treatment Period: ARR Poisson Regression Estimates |
0.236; 0.193; 0.252 | — |
Eligibility Criteria
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.
Extension criteria:
The participants who met all the following criteria at the end of the core study period were eligible for enrolment into the open-label extension phase:
- Participants who had not discontinued treatment in the core period and who had a minimum treatment of 48 weeks and completed the EOT visit (Visit 18).
- Participants who had not met criteria for treatment withdrawal.
- An informed consent must be obtained in writing from the participant for this open-label extension phase prior to entering and prior to completion of any extension phase procedure.
- Participants who demonstrated a willingness and ability to roll over to the extension phase with the opportunity to continue treatment on 14 mg/day of teriflunomide under open-label.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT00883337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.