Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Two-arm, Randomized, Double-blind, Control Group-compared, Multicenter, Phase IIIb Study With Monthly MRI and Biomarker Assessments to Evaluate the Efficacy, Safety, and Tolerability of Rebif® New Formulation (IFN Beta-1a) in Subjects With Relapsing Remitting Multiple Sclerosis
Brief Summary: General Note: throughout this record, "Rebif® New Formulation" is used for historical and consistency purposes.

Objectives:

Primary: To evaluate the efficacy of Rebif® New Formulation (Interferon-beta-1a \[IFN-beta-1a\], RNF), compared to placebo, in subjects with Relapsing Remitting Multiple Sclerosis and active disease by means of Magnetic Resonance Imaging (MRI) at the end of 16 weeks of treatment Secondary: To evaluate the efficacy of RNF by comparing the mean number of combined unique (CU) lesions per scan per subject between the initial 16 weeks of placebo treatment and 24 weeks of RNF treatment in the same subjects, originally randomized to placebo.

Primary Endpoints: The primary endpoint is the difference between the number of CU active MRI lesions at Week 16 in the RNF group (Group 1) versus the placebo group (Group 2).

Secondary Endpoints: The secondary endpoint is the difference in the mean number of CU active MRI lesions per scan per subject over the following treatment periods: Study Day 1 - Week 16 versus Weeks 17 - 40 for the subjects randomized to Group 2.


Options:
A: Arm Label: Cladribine 5.25 mg/kg (ITP); Type: EXPERIMENTAL; Interventions: Drug: Cladribine, Drug: Rebif® new formulation (RNF) | Arm Label: Cladribine 3.5 mg/kg (ITP); Type: EXPERIMENTAL; Interventions: Drug: Cladribine, Drug: Rebif® new formulation (RNF) | Arm Label: Placebo (ITP); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Rebif® new formulation (RNF) | Arm Label: Cladribine 5.25 mg/kg, Rebif (OLMP); Type: EXPERIMENTAL; Interventions: Drug: Cladribine, Drug: Rebif® new formulation (RNF) | Arm Label: Cladribine 3.5 mg/kg, Rebif (OLMP); Type: EXPERIMENTAL; Interventions: Drug: Cladribine, Drug: Rebif® new formulation (RNF) | Arm Label: Placebo, Rebif (OLMP); Type: EXPERIMENTAL; Interventions: Drug: Placebo | Arm Label: Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU); Type: EXPERIMENTAL; Interventions: Drug: Cladribine, Drug: Rebif® new formulation (RNF) | Arm Label: Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU); Type: EXPERIMENTAL; Interventions: Drug: Cladribine, Drug: Rebif® new formulation (RNF) | Arm Label: Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU); Type: EXPERIMENTAL; Interventions: Drug: Placebo | Arm Label: Cladribine 5.25 mg/kg, Rebif (LTFU); Type: EXPERIMENTAL; Interventions: Drug: Cladribine, Drug: Rebif® new formulation (RNF) | Arm Label: Cladribine 3.5 mg/kg, Rebif (LTFU); Type: EXPERIMENTAL; Interventions: Drug: Cladribine, Drug: Rebif® new formulation (RNF) | Arm Label: Placebo, Rebif (LTFU); Type: EXPERIMENTAL; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Cladribine; Assigned to Arm(s): Cladribine 3.5 mg/kg (ITP), Cladribine 3.5 mg/kg, Rebif (LTFU), Cladribine 3.5 mg/kg, Rebif (OLMP), Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU), Cladribine 5.25 mg/kg (ITP), Cladribine 5.25 mg/kg, Rebif (LTFU), Cladribine 5.25 mg/kg, Rebif (OLMP), Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (ITP), Placebo, Rebif (LTFU), Placebo, Rebif (OLMP), Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU) | Intervention Type: DRUG; Name: Rebif® new formulation (RNF); Assigned to Arm(s): Cladribine 3.5 mg/kg (ITP), Cladribine 3.5 mg/kg, Rebif (LTFU), Cladribine 3.5 mg/kg, Rebif (OLMP), Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU), Cladribine 5.25 mg/kg (ITP), Cladribine 5.25 mg/kg, Rebif (LTFU), Cladribine 5.25 mg/kg, Rebif (OLMP), Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU), Placebo (ITP)
B: Arm Label: Active drug; Type: ACTIVE_COMPARATOR; Interventions: Drug: Dimethyl fumarate | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Dimethyl fumarate; Assigned to Arm(s): Active drug | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Rebif® New Formulation (IFN-beta-1a, RNF); Type: EXPERIMENTAL; Interventions: Drug: Rebif® New Formulation (IFN-beta-1a, RNF) | Arm Label: Placebo/RNF; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Rebif® New Formulation (IFN-beta-1a, RNF) | Intervention Type: DRUG; Name: Rebif® New Formulation (IFN-beta-1a, RNF); Assigned to Arm(s): Rebif® New Formulation (IFN-beta-1a, RNF) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo/RNF | Intervention Type: DRUG; Name: Rebif® New Formulation (IFN-beta-1a, RNF); Assigned to Arm(s): Placebo/RNF
D: Arm Label: Placebo/Teriflunomide 7 mg or Teriflunomide 14 mg; Type: PLACEBO_COMPARATOR; Interventions: Drug: Teriflunomide, Drug: Placebo | Arm Label: Teriflunomide 7 mg/7 mg; Type: EXPERIMENTAL; Interventions: Drug: Teriflunomide | Arm Label: Teriflunomide 14 mg/14 mg; Type: EXPERIMENTAL; Interventions: Drug: Teriflunomide | Intervention Type: DRUG; Name: Teriflunomide; Assigned to Arm(s): Placebo/Teriflunomide 7 mg or Teriflunomide 14 mg, Teriflunomide 14 mg/14 mg, Teriflunomide 7 mg/7 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo/Teriflunomide 7 mg or Teriflunomide 14 mg

Answer: C