Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00883337 | A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | PHASE3 | COMPLETED | 324 | — | — | Apr 1, 2009 | May 1, 2015 | Jun 13, 2016 | 54 | Belgium, Canada +11 |
Failure was defined as the first occurence of confirmed relapse or permanent treatment discontinuation (for any cause) which ever came first. If no events occurred, the participant was considered free of failure. Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale \[EDSS\] score or Functional System scores.
Probability of disability progression at 24, 48 and 96 weeks was estimated using Kaplan-Meier method on the time to failure defined as the time from randomization to failure. Participants free of failure were censored at the date of last treatment. Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t.
| Arm | Type | Description |
|---|---|---|
| Teriflunomide 7 mg / 14 mg | EXPERIMENTAL | Teriflunomide 7 mg once daily (core treatment period) and teriflunomide 14 mg once daily (extended treatment period). |
| Teriflunomide 14 mg / 14 mg | EXPERIMENTAL | Teriflunomide 14 mg once daily (core treatment period) and teriflunomide 14 mg once daily (extension treatment period). |
| IFN-β-1a / 14 mg | ACTIVE_COMPARATOR | Interferon β-1a 3 times a week (core treatment period) and teriflunomide 14 mg once daily (extended treatment period). |
| Name | Type | Description |
|---|---|---|
| Interferon β-1a | DRUG | 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 | DRUG | Film-coated tablet Oral administration |
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; * Persiste...