Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Rebif®
RNF · 2 trials · 2 indications
CDMS was defined by the occurrence of a second attack or relapse over 36 months in participants who presented with clinically isolated syndrome (CIS) accompanied by an abnormal magnetic resonance imaging (MRI) scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis \[MS\]) was calculated. Time to conversion to CDMS was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with CDMS.
The McDonald criteria use dissemination in time and space established by magnetic resonance image (MRI) findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new time constant 2 (T2) or gadolinium-enhancing (Gd+) lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions.
| Arm | Type | Description |
|---|---|---|
| RNF 44 mcg thrice weekly | ACTIVE_COMPARATOR | - |
| RNF 44 mcg once weekly and placebo | ACTIVE_COMPARATOR | - |
| Placebo/RNF 44 mcg thrice weekly | ACTIVE_COMPARATOR | - |
| RNF 44 mcg three times weekly | ACTIVE_COMPARATOR | - |
| RNF 44 mcg once weekly and placebo twice weekly for blinding | ACTIVE_COMPARATOR | - |
| Placebo three times weekly | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| RNF | DRUG | Single dose of RNF will be administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. |
| Placebo | DRUG | Single dose matching placebo will be administered subcutaneously twice weekly. Placebo is supplied as a transparent, sterile solution for injection in pre-filled syringes matching the RNF pre-filled syringes, each containing 0.5 milliliter (mL). |
Inclusion Criteria: * Reach scheduled end of study in Study 27025 (REFLEX) (completion of 24 months participation) * Medical assessment by the Investigator/treating physician from study 27025 that there is no objection to the subject's participation in this extension trial considering the medical e...
Top 17 of 21 competitors