Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of Oral Cladribine in Subjects With a First Clinical Event at High Risk of Converting to MS
Brief Summary: A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome). Participants in either the cladribine or placebo group may also enter treatment periods with open-label interferon-beta or open-label cladribine depending upon the disease status. The primary objective of this study is to evaluate the effect of two dosage regimens of oral cladribine versus placebo on the time to conversion to multiple sclerosis (MS) (from randomization) according to the Poser criteria in participants with first clinical demyelinating event at high risk of converting to MS.


Options:
A: Arm Label: RNF 44 mcg thrice weekly; Type: ACTIVE_COMPARATOR; Interventions: Drug: RNF | Arm Label: RNF 44 mcg once weekly and placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: RNF, Drug: Placebo | Arm Label: Placebo/RNF 44 mcg thrice weekly; Type: ACTIVE_COMPARATOR; Interventions: Drug: RNF | Intervention Type: DRUG; Name: RNF; Assigned to Arm(s): RNF 44 mcg thrice weekly | Intervention Type: DRUG; Name: RNF; Assigned to Arm(s): RNF 44 mcg once weekly and placebo | Intervention Type: DRUG; Name: RNF; Assigned to Arm(s): Placebo/RNF 44 mcg thrice weekly | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): RNF 44 mcg once weekly and placebo
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Ocrelizumab 600 mg; Type: EXPERIMENTAL; Interventions: Drug: Ocrelizumab | Arm Label: Ocrelizumab 1000 mg; Type: EXPERIMENTAL; Interventions: Drug: Ocrelizumab | Arm Label: Avonex; Type: ACTIVE_COMPARATOR; Interventions: Drug: Avonex | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Ocrelizumab; Assigned to Arm(s): Ocrelizumab 1000 mg, Ocrelizumab 600 mg | Intervention Type: DRUG; Name: Avonex; Assigned to Arm(s): Avonex
C: 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)
D: Arm Label: Immediate Treatment Group; Type: EXPERIMENTAL; Interventions: Drug: interferon beta 1a 30 ug IM once weekly | Arm Label: Delayed Treatment Group; Type: ACTIVE_COMPARATOR; Interventions: Drug: interferon beta 1a 30 ug IM once weekly | Intervention Type: DRUG; Name: interferon beta 1a 30 ug IM once weekly; Assigned to Arm(s): Delayed Treatment Group, Immediate Treatment Group

Answer: C