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 New Formulation+ prophylactic Ibuprofen refers to treatment with Rebif New Formulation, a subcutaneous interferon beta-1a therapy, given together with ibuprofen taken before dosing to manage flu-like symptoms. It is used in multiple sclerosis, including relapsing-remitting multiple sclerosis, relapsing multiple sclerosis, and clinically isolated syndrome.
Rebif New Formulation+ prophylactic Ibuprofen is used to treat multiple sclerosis, including relapsing-remitting multiple sclerosis, relapsing multiple sclerosis, and clinically isolated syndrome. The prophylactic ibuprofen component is taken to reduce interferon-related flu-like side effects that can occur after subcutaneous interferon beta-1a injections.
Rebif New Formulation+ prophylactic Ibuprofen is developed by Merck KGaA, which trades under the ticker MKGAF. Merck KGaA is the company behind the Rebif brand of subcutaneous interferon beta-1a used in multiple sclerosis.
Rebif New Formulation+ prophylactic Ibuprofen has been studied in Phase 3 clinical development. The Phase 3 trials of Rebif New Formulation in relapsing multiple sclerosis and relapsing-remitting multiple sclerosis have been completed.
Clinical trials include NCT00619307, a Phase 3 transition study to Rebif New Formulation in relapsing multiple sclerosis, and NCT00441103, a Phase 3 study of Rebif New Formulation in relapsing-remitting multiple sclerosis. NCT00287079 studied Rebif in clinically isolated syndrome, and NCT01198132 studied cholecalciferol with interferon beta-1a in relapsing multiple sclerosis.
Rebif New Formulation+ prophylactic Ibuprofen is a regimen that includes Rebif New Formulation, also known as Rebif or Rebif New Formulation (IFN-beta-1a, RNF), together with prophylactic ibuprofen. Rebif is the interferon beta-1a product, while the prophylactic ibuprofen is an added anti-inflammatory measure.