Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Interferon beta-1a · 1 trial · 1 indication
EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with Baseline score of 1.0 or more; and the increase persisted for at least next the 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Probability of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.
Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated using a Poisson regression model with observed number of relapses as a dependent variable, the log total amount of follow-up from date of randomization for each participant as an offset variable and treatment group indicator as a covariate.
| Arm | Type | Description |
|---|---|---|
| Interferon Beta-1a | ACTIVE_COMPARATOR | - |
| Alemtuzumab 12 mg | EXPERIMENTAL | - |
| Alemtuzumab 24 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Interferon beta-1a | BIOLOGICAL | Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 36 months. |
| Alemtuzumab 12 mg | BIOLOGICAL | Alemtuzumab 12 milligram per day (mg/day) was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the cluster of differentiation 4+ \[CD4+\] T-cell count was \>=100\*10\^6 cells per liter). |
| Alemtuzumab 24 mg | BIOLOGICAL | Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was \>=100\*10\^6 cells per liter). |
Inclusion Criteria: * Signed informed consent form (ICF) * Male or non-pregnant, non-lactating female participants, 18 to 50 years of age (inclusive) as of signing the ICF * Diagnosis of MS per McDonald's update of the Poser criteria, including cranial MRI consistent with those criteria (McDonald, ...
Interferon beta-1a is used for the treatment of relapsing-remitting multiple sclerosis, a form of multiple sclerosis characterized by episodes of new or worsening symptoms followed by periods of recovery. It is being studied in a Phase 2 clinical trial for this condition.
Interferon beta-1a is developed by Sanofi, a company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical research on this drug for the treatment of relapsing-remitting multiple sclerosis.
Interferon beta-1a is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to evaluate its safety and efficacy for relapsing-remitting multiple sclerosis.
Interferon beta-1a is being studied in a completed Phase 2 clinical trial with the identifier NCT00050778. This trial compared low- and high-dose alemtuzumab and high-dose Rebif in patients with early, active relapsing-remitting multiple sclerosis. The trial enrolled 334 participants across the United States, Croatia, Poland, Russia, and the United Kingdom.
Yes, Interferon beta-1a is classified as a monoclonal antibody. It is being developed for the treatment of relapsing-remitting multiple sclerosis and is currently in Phase 2 clinical development.