Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis
Brief Summary: This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.


Options:
A: Arm Label: 001; Type: EXPERIMENTAL; Interventions: Drug: Golimumab | Arm Label: 002; Type: EXPERIMENTAL; Interventions: Drug: Golimumab | Intervention Type: DRUG; Name: Golimumab; Assigned to Arm(s): 002 | Intervention Type: DRUG; Name: Golimumab; Assigned to Arm(s): 001
B: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: Infliximab, methylprednisolone, methotrexate, Drug: Methotrexate | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: Infliximab, methylprednisolone, methotrexate, Drug: Methotrexate + Methylprednisolone | Arm Label: C; Type: ACTIVE_COMPARATOR; Interventions: Drug: Infliximab, methylprednisolone, methotrexate, Drug: Methotrexate + Infliximab | Intervention Type: DRUG; Name: Infliximab, methylprednisolone, methotrexate; Assigned to Arm(s): A, B, C | Intervention Type: DRUG; Name: Methotrexate; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Methotrexate + Methylprednisolone; Assigned to Arm(s): B | Intervention Type: DRUG; Name: Methotrexate + Infliximab; Assigned to Arm(s): C
C: Arm Label: CDP6038 60 mg sc every 2 weeks plus methotrexate; Type: EXPERIMENTAL; Interventions: Biological: CDP6038, Other: Placebo iv | Arm Label: CDP6038 60 mg sc every 4 weeks plus methotrexate; Type: EXPERIMENTAL; Interventions: Biological: CDP6038, Other: Placebo sc, Other: Placebo iv | Arm Label: CDP6038 120 mg sc every 2 weeks plus methotrexate; Type: EXPERIMENTAL; Interventions: Biological: CDP6038, Other: Placebo iv | Arm Label: CDP6038 120 mg sc every 4 weeks plus methotrexate; Type: EXPERIMENTAL; Interventions: Biological: CDP6038, Other: Placebo sc, Other: Placebo iv | Arm Label: CDP6038 240 mg sc every 2 weeks plus methotrexate; Type: EXPERIMENTAL; Interventions: Biological: CDP6038, Other: Placebo iv | Arm Label: CDP6038 240 mg sc every 4 weeks plus methotrexate; Type: EXPERIMENTAL; Interventions: Biological: CDP6038, Other: Placebo sc, Other: Placebo iv | Arm Label: Tocilizumab 8 mg/kg iv every 4 weeks plus methotrexate; Type: ACTIVE_COMPARATOR; Interventions: Biological: Tocilizumab (Actemra or RoActemra), Other: Placebo sc | Arm Label: Placebo sc every 2 weeks plus methotrexate; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo sc, Other: Placebo iv | Arm Label: Placebo sc every 4 weeks plus methotrexate; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo sc, Other: Placebo iv | Intervention Type: BIOLOGICAL; Name: CDP6038; Assigned to Arm(s): CDP6038 60 mg sc every 2 weeks plus methotrexate | Intervention Type: BIOLOGICAL; Name: CDP6038; Assigned to Arm(s): CDP6038 120 mg sc every 2 weeks plus methotrexate | Intervention Type: BIOLOGICAL; Name: CDP6038; Assigned to Arm(s): CDP6038 240 mg sc every 2 weeks plus methotrexate | Intervention Type: BIOLOGICAL; Name: Tocilizumab (Actemra or RoActemra); Assigned to Arm(s): Tocilizumab 8 mg/kg iv every 4 weeks plus methotrexate | Intervention Type: BIOLOGICAL; Name: CDP6038; Assigned to Arm(s): CDP6038 60 mg sc every 4 weeks plus methotrexate | Intervention Type: BIOLOGICAL; Name: CDP6038; Assigned to Arm(s): CDP6038 240 mg sc every 4 weeks plus methotrexate | Intervention Type: BIOLOGICAL; Name: CDP6038; Assigned to Arm(s): CDP6038 120 mg sc every 4 weeks plus methotrexate | Intervention Type: OTHER; Name: Placebo sc; Assigned to Arm(s): Placebo sc every 2 weeks plus methotrexate, Placebo sc every 4 weeks plus methotrexate, Tocilizumab 8 mg/kg iv every 4 weeks plus methotrexate | Intervention Type: OTHER; Name: Placebo sc; Assigned to Arm(s): CDP6038 120 mg sc every 4 weeks plus methotrexate, CDP6038 240 mg sc every 4 weeks plus methotrexate, CDP6038 60 mg sc every 4 weeks plus methotrexate | Intervention Type: OTHER; Name: Placebo iv; Assigned to Arm(s): CDP6038 120 mg sc every 2 weeks plus methotrexate, CDP6038 120 mg sc every 4 weeks plus methotrexate, CDP6038 240 mg sc every 2 weeks plus methotrexate, CDP6038 240 mg sc every 4 weeks plus methotrexate, CDP6038 60 mg sc every 2 weeks plus methotrexate, CDP6038 60 mg sc every 4 weeks plus methotrexate, Placebo sc every 2 weeks plus methotrexate, Placebo sc every 4 weeks plus methotrexate
D: Arm Label: Tocilizumab 162 mg sc; Type: EXPERIMENTAL; Interventions: Drug: Tocilizumab 162 mg | Arm Label: Placebo sc; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Tocilizumab 162 mg; Assigned to Arm(s): Tocilizumab 162 mg sc | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo sc

Answer: D