Approval Probability
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Rebif · 2 trials · 2 indications
CDMS was defined by the occurrence of a second exacerbation or relapse over 96 weeks in participants who presented with Clinically Isolated Syndrome (CIS) accompanied by an abnormal Magnetic Resonance Imaging (MRI) scan. Time was calculated from the date of the stabilization of the baseline CIS episode to the qualifying relapse for the CDMS.
The annualized relapse rate was calculated for each treatment group as follows: the number of relapses observed during the study period divided by the time spent in the study (in years).
| Arm | Type | Description |
|---|---|---|
| Rebif® | EXPERIMENTAL | - |
| No Treatment | OTHER | - |
| Cholecalciferol | EXPERIMENTAL | Subjects receive Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 3 times a week. |
| Placebo | PLACEBO_COMPARATOR | Subjects receive matching placebo to Cholecalciferol once every two weeks along with subcutaneous injection of Rebif 3 times weekly. |
| Name | Type | Description |
|---|---|---|
| Rebif® | DRUG | 44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks |
| No Treatment | OTHER | No treatment for 96 weeks |
| Cholecalciferol (Vitamin D3) | DIETARY_SUPPLEMENT | Subjects receive Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week. |
| Placebo | DIETARY_SUPPLEMENT | Subjects receive matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly. |
| Rebif | DRUG | Subjects receive subcutaneous injection of Rebif 44 mcg 3 times weekly. |
Inclusion Criteria: * Subject must have experienced a first clinical episode suggestive of demyelinating disease * Subject must present with an abnormal MRI displaying at least 3 T2 weighted hyperintense lesions typical of multiple sclerosis (MS) * Subject must be greater than or equal to 18 years ...
Rebif is used for Clinically Isolated Syndrome and Multiple Sclerosis. It is an investigational small molecule in Phase 3 development for these neurological conditions. Rebif is being studied in patients with Clinically Isolated Syndrome and in patients with Relapsing Multiple Sclerosis.
Rebif is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate Rebif for the treatment of Clinically Isolated Syndrome and Multiple Sclerosis.
Rebif is in Phase 3 clinical development. It is being studied for Clinically Isolated Syndrome and Multiple Sclerosis. Rebif is investigational and not yet approved, as it is still undergoing clinical trials to assess its safety and efficacy.
Rebif has been studied in clinical trials including NCT00287079, a Phase 3 study in Clinically Isolated Syndrome with 35 participants in Canada, and NCT01198132, a Phase 2 study in Multiple Sclerosis with 129 participants in France. Both trials are completed.
Rebif is a form of interferon beta-1a, as indicated by its use in trials with subcutaneous interferon beta-1a. In clinical studies, Rebif is administered as a subcutaneous injection at a dose of 44 µg three times weekly for the treatment of Multiple Sclerosis.