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Rebif New Formulation · 1 trial · 1 indication
CU active lesions were defined as a unique newly active or persistently active lesion on the protocol density/time constant 2 (PD/T2) scan or the gadolinium (Gd-) enhanced time constant 1 (T1) scan (with a method to avoid double counting).
An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. AEs were categorized based upon the treatment period during which they occurred, that is, double-blind period (up to Week 16) and rater-blind period (Week 17 up to Week 40).
| Arm | Type | Description |
|---|---|---|
| Rebif® New Formulation (IFN-beta-1a, RNF) | EXPERIMENTAL | - |
| Placebo/RNF | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Rebif® New Formulation (IFN-beta-1a, RNF) | DRUG | RNF will be administered at a dose of 44 mcg subcutaneously three times a week for 40 weeks. |
| Placebo | DRUG | Matching placebo will be administered subcutaneously three times a week for 16 weeks. |
Inclusion Criteria: * Males and females between 18 and 60 years of age * Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either: post-menopausal or surgically sterile or use an effective method of contraception for the duration of the...
Rebif New Formulation is used for the treatment of relapsing-remitting multiple sclerosis and relapsing multiple sclerosis. It is an investigational small molecule being developed by Merck KGaA for these neurological conditions.
Rebif New Formulation is being developed by Merck KGaA, a company traded under the ticker MKGAF. The drug is currently in Phase 3 clinical development for multiple sclerosis indications.
Rebif New Formulation is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed for relapsing-remitting and relapsing multiple sclerosis.
Rebif New Formulation has completed two Phase 3 trials. NCT00441103 evaluated the drug in 180 patients with relapsing-remitting multiple sclerosis. NCT00619307 studied transition to Rebif New Formulation in 117 patients with relapsing multiple sclerosis in France and Germany.
Rebif New Formulation is a new formulation of interferon-beta-1a, the active ingredient in Rebif. The clinical trials evaluate this updated formulation in patients with relapsing-remitting and relapsing multiple sclerosis.