Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial of Rebif New Formulation (44 Microgram [Mcg] Three Times Weekly [Tiw] and 44 Mcg Once Weekly [ow]) in Subjects at High Risk of Converting to Multiple Sclerosis (REFLEX)
Brief Summary: The study is a 24 months randomized, double-blind, Placebo-controlled, multi-center clinical trial with an optional 12 months open label extension.

The primary objective of the study is to evaluate the effect of fetal bovine serum \[FBS\]-free/human serum albumin \[HSA\]-free formulation of Interferon \[IFN\] beta-1a (RNF) 44 microgram (three times weekly and once weekly) versus placebo on the time to conversion to McDonald multiple sclerosis (MS) criteria (2005) in subjects with a first clinical demyelinating event at high risk of converting to MS.

The main secondary objective of study is to evaluate the effect of RNF 44 microgram (three times weekly and once weekly) versus placebo on the "Time to conversion to clinically definite MS (CDMS)" in subjects with a first clinical demyelinating event at high risk of converting to MS.

At the end of 24 month double-blind core REFLEX trial, subjects who will not convert to CDMS and decide to receive open-label (OL) treatment will be enrolled into an open-label, 12 month extension period to evaluate the effect of RNF 44 mcg three times weekly treatment on the time to conversion to McDonald MS and time to conversion to CDMS.


Options:
A: Arm Label: fingolimod 0.5 mg; Type: EXPERIMENTAL; Interventions: Drug: fingolimod | Arm Label: fingolimod 0.25mg; Type: EXPERIMENTAL; Interventions: Drug: fingolimod | Arm Label: glatiramer acetate 20 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: glatiramer acetate | Intervention Type: DRUG; Name: fingolimod; Assigned to Arm(s): fingolimod 0.25mg, fingolimod 0.5 mg | Intervention Type: DRUG; Name: glatiramer acetate; Assigned to Arm(s): glatiramer acetate 20 mg
B: Arm Label: RNF 44 mcg three times weekly; Type: ACTIVE_COMPARATOR; Interventions: Drug: RNF | Arm Label: RNF 44 mcg once weekly and placebo twice weekly for blinding; Type: ACTIVE_COMPARATOR; Interventions: Drug: RNF, Drug: Placebo | Arm Label: Placebo three times weekly; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: RNF; Assigned to Arm(s): RNF 44 mcg once weekly and placebo twice weekly for blinding, RNF 44 mcg three times weekly | Intervention Type: DRUG; Name: RNF; Assigned to Arm(s): RNF 44 mcg once weekly and placebo twice weekly for blinding, RNF 44 mcg three times weekly | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo three times weekly, RNF 44 mcg once weekly and placebo twice weekly for blinding
C: Arm Label: Fingolimod 1.25 mg; Type: EXPERIMENTAL; Interventions: Drug: Fingolimod | Arm Label: Fingolimod 0.5 mg; Type: EXPERIMENTAL; Interventions: Drug: Fingolimod | Arm Label: Placebo; Type: EXPERIMENTAL; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Fingolimod; Assigned to Arm(s): Fingolimod 0.5 mg, Fingolimod 1.25 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: OMB 20 mg; Type: EXPERIMENTAL; Interventions: Drug: Ofatumumab subcutaneous injection, Drug: Teriflunomide-matching placebo capsules | Arm Label: TER 14 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Teriflunomide capsule, Drug: Matching placebo of ofatumumab subcutaneous injections | Intervention Type: DRUG; Name: Ofatumumab subcutaneous injection; Assigned to Arm(s): OMB 20 mg | Intervention Type: DRUG; Name: Teriflunomide-matching placebo capsules; Assigned to Arm(s): OMB 20 mg | Intervention Type: DRUG; Name: Teriflunomide capsule; Assigned to Arm(s): TER 14 mg | Intervention Type: DRUG; Name: Matching placebo of ofatumumab subcutaneous injections; Assigned to Arm(s): TER 14 mg

Answer: B