Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rebif New Formulation+ prophylactic Ibuprofen · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Transition with prophylactic ibuprofen | ACTIVE_COMPARATOR | - |
| Transition with PRN ibuprofen | ACTIVE_COMPARATOR | - |
| 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. |
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 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.