Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis
Brief Summary: This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of tocilizumab in participants with GCA. The study will consist of 2 parts: a 52-week double-blind treatment period (Part 1) followed by a 104-week open label long-term follow-up period (Part 2). In Part 1 of the study eligible participants will be randomized to receive either tocilizumab every week (qw) or every 2 weeks (q2w) or placebo for 52 weeks, with tapering oral daily doses of prednisone. After Week 52, participants in remission will stop study treatment and enter long-term follow-up, whereas participants with disease activity or flares will receive open-label tocilizumab or other treatment at the discretion of the investigator for a maximum period of 104 weeks.


Options:
A: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Tocilizumab; Type: EXPERIMENTAL; Interventions: Drug: Tocilizumab | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Tocilizumab; Assigned to Arm(s): Tocilizumab
B: Arm Label: Sarilumab 200mg IV (P2); Type: EXPERIMENTAL; Interventions: Drug: Sarilumab, Drug: Placebo | Arm Label: Sarilumab 200mg IV (P3:C1); Type: EXPERIMENTAL; Interventions: Drug: Sarilumab, Drug: Placebo | Arm Label: Sarilumab 400mg IV (P2); Type: EXPERIMENTAL; Interventions: Drug: Sarilumab, Drug: Placebo | Arm Label: Sarilumab 400mg IV (P3:C1); Type: EXPERIMENTAL; Interventions: Drug: Sarilumab, Drug: Placebo | Arm Label: Sarilumab 800mg IV (P3:C2); Type: EXPERIMENTAL; Interventions: Drug: Sarilumab, Drug: Placebo | Arm Label: Sarilumab 800mg IV (P3: C3); Type: EXPERIMENTAL; Interventions: Drug: Sarilumab, Drug: Placebo | Intervention Type: DRUG; Name: Sarilumab; Assigned to Arm(s): Sarilumab 200mg IV (P2), Sarilumab 200mg IV (P3:C1), Sarilumab 400mg IV (P2), Sarilumab 400mg IV (P3:C1), Sarilumab 800mg IV (P3: C3), Sarilumab 800mg IV (P3:C2) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Sarilumab 200mg IV (P2), Sarilumab 200mg IV (P3:C1), Sarilumab 400mg IV (P2), Sarilumab 400mg IV (P3:C1), Sarilumab 800mg IV (P3: C3), Sarilumab 800mg IV (P3:C2)
C: Arm Label: Tradipitant; Type: EXPERIMENTAL; Interventions: Drug: Tradipitant | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Tradipitant; Assigned to Arm(s): Tradipitant | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Part 1: Tocilizumab qw + 26 weeks prednisone taper; Type: EXPERIMENTAL; Interventions: Drug: Tocilizumab, Drug: Prednisone, Drug: Prednisone Placebo | Arm Label: Part 1: Tocilizumab q2w + 26 weeks prednisone taper; Type: EXPERIMENTAL; Interventions: Drug: Tocilizumab, Drug: Prednisone, Drug: Tocilizumab Placebo, Drug: Prednisone Placebo | Arm Label: Part 1: Placebo + 26 weeks prednisone taper; Type: PLACEBO_COMPARATOR; Interventions: Drug: Prednisone, Drug: Tocilizumab Placebo, Drug: Prednisone Placebo | Arm Label: Part 1: Placebo + 52 weeks prednisone taper; Type: PLACEBO_COMPARATOR; Interventions: Drug: Prednisone, Drug: Tocilizumab Placebo, Drug: Prednisone Placebo | Arm Label: Part 2: Open-Label Tocilizumab qw; Type: EXPERIMENTAL; Interventions: Drug: Tocilizumab, Drug: Corticosteroids, Drug: Methotrexate | Intervention Type: DRUG; Name: Tocilizumab; Assigned to Arm(s): Part 1: Tocilizumab q2w + 26 weeks prednisone taper, Part 1: Tocilizumab qw + 26 weeks prednisone taper, Part 2: Open-Label Tocilizumab qw | Intervention Type: DRUG; Name: Prednisone; Assigned to Arm(s): Part 1: Placebo + 26 weeks prednisone taper, Part 1: Placebo + 52 weeks prednisone taper, Part 1: Tocilizumab q2w + 26 weeks prednisone taper, Part 1: Tocilizumab qw + 26 weeks prednisone taper | Intervention Type: DRUG; Name: Tocilizumab Placebo; Assigned to Arm(s): Part 1: Placebo + 26 weeks prednisone taper, Part 1: Placebo + 52 weeks prednisone taper, Part 1: Tocilizumab q2w + 26 weeks prednisone taper | Intervention Type: DRUG; Name: Prednisone Placebo; Assigned to Arm(s): Part 1: Placebo + 26 weeks prednisone taper, Part 1: Placebo + 52 weeks prednisone taper, Part 1: Tocilizumab q2w + 26 weeks prednisone taper, Part 1: Tocilizumab qw + 26 weeks prednisone taper | Intervention Type: DRUG; Name: Corticosteroids; Assigned to Arm(s): Part 2: Open-Label Tocilizumab qw | Intervention Type: DRUG; Name: Methotrexate; Assigned to Arm(s): Part 2: Open-Label Tocilizumab qw

Answer: D