Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Rebif New Formulation, Interferon beta-1a, Curcumin, BCM95, RNF, Interferon beta-1a (Rebif), Rebif (Interferon beta-1a)
Rebif · 4 trials · 4 indications
This is defined as the sum of the scores for the "side effects" section questions 1-4, with a minimum possible total score of 1 and a maximum possible total score of 20 in the MSTCQ. The lower the score, the better the outcome.
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).
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 |
|---|---|---|
| Transition with prophylactic ibuprofen | ACTIVE_COMPARATOR | - |
| Transition with PRN ibuprofen | ACTIVE_COMPARATOR | - |
| Rebif® New Formulation (IFN-beta-1a, RNF) | EXPERIMENTAL | - |
| Placebo/RNF | PLACEBO_COMPARATOR | - |
| 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 New Formulation + prophylactic Ibuprofen | DRUG | Subjects, currently on Rebif® 44 mcg three times a week, using Rebiject II as an injection device and having received Rebif® full dose 44 mcg three times a week for at least 6 months, receives systematically 400 mg ibuprofen as prophylactic treatment against flu-like symptoms on days when Rebif New Formulation 44 mcg three times a week is injected |
| Rebif New Formulation + ibuprofen PRN | DRUG | Subjects, currently on Rebif® 44 mcg three times a week, using Rebiject II as an injection device and having received Rebif® full dose 44 mcg three times a week for at least 6 months, should not administer Ibuprofen before the first Rebif New Formulation injection. If flu-like symptoms occur after the 44 mcg Rebif New Formulation injection then the subject can administer 400 mg ibuprofen. This should only be administered after the Rebif New Formulation injection and not before the Rebif New Formulation injection. |
| 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. |
| 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. |
| Rebif | DRUG | Subjects receive subcutaneous injection of Rebif 44 mcg 3 times weekly. |
Inclusion Criteria: * Subject with relapsing forms of Multiple Sclerosis (MS) * Expanded disability status scale (EDSS) score \< 5.5 at study entry * Subjects who have been administering Rebif 44 mcg three times a week for at least 6 months prior to study enrolment * Subject currently using Rebijec...
Rebif is used to treat multiple sclerosis, including relapsing-remitting multiple sclerosis, relapsing multiple sclerosis, and clinically isolated syndrome. It is a subcutaneous interferon beta-1a therapy developed by Merck KGaA. The clinical program covers patients with relapsing forms of the disease as well as those presenting with a first demyelinating episode.
Rebif is developed by Merck KGaA, which trades over the counter in the United States under the ticker MKGAF. The company sponsors the clinical trials evaluating Rebif and its new formulation in multiple sclerosis and clinically isolated syndrome.
Rebif has been studied in Phase 3 clinical trials, including the Transition to Rebif New Formulation study and a Phase 3 evaluation in relapsing-remitting multiple sclerosis. Additional Phase 2 research has examined supplementary cholecalciferol in patients receiving subcutaneous interferon beta-1a 44 µg three times weekly.
Rebif has been evaluated in completed trials including NCT00441103, a Phase 3 study of Rebif New Formulation in relapsing-remitting multiple sclerosis with 180 participants, and NCT00619307, a Phase 3 transition study in relapsing multiple sclerosis. NCT00287079 studied Rebif in clinically isolated syndrome, and NCT01198132 tested supplementary cholecalciferol with interferon beta-1a.
Yes. Rebif New Formulation, also written as RNF, is the same interferon beta-1a product as Rebif, and the name is sometimes paired with prophylactic ibuprofen to describe the dosing approach. Searches for Rebif New Formulation, Rebif® New Formulation, or Rebif New Formulation plus prophylactic ibuprofen all refer to this same therapy.
Rebif is used in clinically isolated syndrome to treat patients who have experienced a first clinical episode suggestive of multiple sclerosis. A Phase 3 prospective study, NCT00287079, evaluated Rebif in subjects with clinically isolated syndrome in Canada, enrolling 35 participants aged 18 months and older.