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: BAF312 10mg (period 1); Type: EXPERIMENTAL; Interventions: Drug: BAF312 | Arm Label: BAF312 2 mg (period 1); Type: EXPERIMENTAL; Interventions: Drug: BAF312 | Arm Label: BAF312 0.5 mg (period 1); Type: EXPERIMENTAL; Interventions: Drug: BAF312 | Arm Label: BAF312 dose between 0.1 to 8 mg period 2; Type: EXPERIMENTAL; Interventions: Drug: BAF312 | Arm Label: BAF312 dose between 0.1 - 8 mg period 2; Type: EXPERIMENTAL; Interventions: Drug: BAF312 | Arm Label: Placebo (period 1, 2); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: BAF312; Assigned to Arm(s): BAF312 0.5 mg (period 1), BAF312 10mg (period 1), BAF312 2 mg (period 1), BAF312 dose between 0.1 - 8 mg period 2, BAF312 dose between 0.1 to 8 mg period 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (period 1, 2)
B: Arm Label: Alemtuzumab; Type: EXPERIMENTAL; Interventions: Drug: alemtuzumab GZ402673 | Intervention Type: DRUG; Name: alemtuzumab GZ402673; Assigned to Arm(s): Alemtuzumab
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: 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)

Answer: D