Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
RNF is an investigational small molecule being developed for the treatment of Multiple Sclerosis. It is currently in Phase 3 clinical development, with completed trials evaluating its use in patients with early Multiple Sclerosis and Clinically Isolated Syndrome.
RNF is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting Phase 3 clinical trials to evaluate the drug for the treatment of Multiple Sclerosis.
RNF is in Phase 3 clinical development for Multiple Sclerosis. Two Phase 3 trials have been completed, with a total enrollment of 919 participants. The drug is investigational and has not been approved by regulatory authorities.
RNF has been studied in two completed Phase 3 trials. The first, NCT00404352, enrolled 517 participants with Multiple Sclerosis. The second, NCT00813709, enrolled 402 participants with Multiple Sclerosis or Clinically Isolated Syndrome and was a long-term follow-up study.
Yes, RNF has been evaluated in randomized, double-blind, placebo-controlled Phase 3 trials. These trials enrolled a total of 919 participants across multiple countries, including the United States and various European nations.