Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Interferon β-1a · 1 trial · 1 indication
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...
Interferon β-1a is used for the treatment of Multiple Sclerosis, specifically in patients with relapsing forms of the disease. It is an investigational therapy that has been studied in a Phase 3 clinical trial to evaluate its effectiveness and safety compared to another active treatment.
Interferon β-1a is being developed by Sanofi, a global biopharmaceutical company. Sanofi's stock is traded under the ticker symbol SNY on the stock exchange.
Interferon β-1a is in Phase 3 of clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy.
Interferon β-1a has been studied in a Phase 3 clinical trial with the identifier NCT00883337. This completed trial enrolled 324 patients with relapsing Multiple Sclerosis and compared the effectiveness and safety of Interferon β-1a against an active control.
No, Interferon β-1a is not the same as Teriflunomide. In the clinical trial NCT00883337, Interferon β-1a was compared with Teriflunomide as an active control. They are distinct treatments with different mechanisms of action.