Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis
Brief Summary: This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with methotrexate (MTX). in patients with moderate to severe active rheumatoid arthritis (RA) who currently have an inadequate response to MTX. Patients wil be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/mg iv, or placebo iv, every 4 weeks; all patients will also receive methotrexate 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Options:
A: Arm Label: Phase 1 Etanercept + methotrexate; Type: EXPERIMENTAL; Interventions: Biological: Phase 1: Etanercept, Drug: Phase 1: Methotrexate, Drug: Phase 2: Optional ETN, SSZ, HCQ, MTX | Arm Label: Phase 1 Conventional DMARD (SSZ or HCQ) + MTX; Type: ACTIVE_COMPARATOR; Interventions: Drug: Phase 1: Methotrexate, Drug: Phase 1: Conventiaonal DMARD | Intervention Type: BIOLOGICAL; Name: Phase 1: Etanercept; Assigned to Arm(s): Phase 1 Etanercept + methotrexate | Intervention Type: DRUG; Name: Phase 1: Methotrexate; Assigned to Arm(s): Phase 1 Etanercept + methotrexate | Intervention Type: DRUG; Name: Phase 2: Optional ETN, SSZ, HCQ, MTX; Assigned to Arm(s): Phase 1 Etanercept + methotrexate | Intervention Type: DRUG; Name: Phase 1: Methotrexate; Assigned to Arm(s): Phase 1 Conventional DMARD (SSZ or HCQ) + MTX | Intervention Type: DRUG; Name: Phase 1: Conventiaonal DMARD; Assigned to Arm(s): Phase 1 Conventional DMARD (SSZ or HCQ) + MTX
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: tocilizumab [RoActemra/Actemra], Drug: Methotrexate | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: tocilizumab [RoActemra/Actemra], Drug: Methotrexate | Arm Label: 3; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Methotrexate | Intervention Type: DRUG; Name: tocilizumab [RoActemra/Actemra]; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: tocilizumab [RoActemra/Actemra]; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: Methotrexate; Assigned to Arm(s): 1, 2, 3
C: Arm Label: methotrexate + adalimumab; Type: EXPERIMENTAL; Interventions: Drug: Adalimumab | Arm Label: methotrexate + placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Adalimumab; Assigned to Arm(s): methotrexate + adalimumab | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): methotrexate + placebo
D: Arm Label: Certolizumab pegol (CZP); Type: EXPERIMENTAL; Interventions: Drug: Certolizumab pegol (CZP) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Certolizumab pegol (CZP); Assigned to Arm(s): Certolizumab pegol (CZP) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo

Answer: B