Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Interferon beta-1a · 1 trial · 1 indication
Frequency of relapses assessed by the annualized relapse rate (ARR). The ARR is defined as the average number of confirmed relapses per year (total number of confirmed relapses divided by the total days in the study multiplied by 365.25).
| Arm | Type | Description |
|---|---|---|
| Fingolimod | EXPERIMENTAL | Fingolimod was administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight) with the aim to achieve systemic exposure in range of that in adults at the licensed 0.5 mg dose. Participants in this arm during core continued into extension and received open-label treatment |
| Interferon beta-1a | ACTIVE_COMPARATOR | An intramuscular (IM) injection of Interferon beta-1a was administered once weekly during core phase. Participants switched to receive open-label fingolimod in extension phase |
| Fingolimod-Younger Cohort | EXPERIMENTAL | The 'younger cohort' refers to the new pediatric patients to be recruited in the extension phase who fulfill any single one or a combination of the following criteria: being ≤12 years of age, or weighing ≤40 kg, or being prepubertal (i.e. pubertal status of Tanner stage \<2) |
| Name | Type | Description |
|---|---|---|
| Interferon beta-1a | DRUG | Administration once weekly via i.m. injections. |
| Fingolimod | DRUG | Administrated orally once daily: 0.5 mg capsule for patients over 40 kg or 0.25 mg capsule for patients 40 kg or less. |
| Placebo capsule | DRUG | Matching placebo capsule required for double-dummy masking to blind formulations. |
| Placebo i.m. injection | DRUG | Matching placebo i.m. injection required for double-dummy masking to blind formulations. |
Key Inclusion Criteria Core Phase: * diagnosis of multiple sclerosis * at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of Gd enhancing lesions on MRI within 6 months EDSS score of 0 to 5.5, inclusive Key Exclusion Criteria Core Phase: * pati...
Interferon beta-1a is used for the treatment of Multiple Sclerosis. It is currently in Phase 3 clinical development for this indication. The drug is being studied in a randomized, double-blind, active-controlled trial to evaluate its safety and efficacy in patients with Multiple Sclerosis.
Interferon beta-1a is being developed by Novartis AG, which is listed on the stock exchange under the ticker symbol NVS. The company is conducting a Phase 3 clinical trial to evaluate the drug's safety and efficacy in patients with Multiple Sclerosis.
Interferon beta-1a is currently in Phase 3 clinical development. It is being investigated as a treatment for Multiple Sclerosis in a randomized, double-blind, active-controlled trial. The drug is not yet approved and remains investigational.
Interferon beta-1a is being studied in a Phase 3 clinical trial with the identifier NCT01892722. This trial is titled 'Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis' and is active but not recruiting. The study has an enrollment of 240 participants and is being conducted in multiple countries.
Interferon beta-1a is being studied in a clinical trial that also evaluates Fingolimod. The trial NCT01892722 is titled 'Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis' and includes Interferon beta-1a as a comparator. The two drugs are different treatments being compared in the same study.