Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: U-ACT-EARLY: A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Evaluate Remission in DMARD and Biological naïve Early Rheumatoid Arthritis (RA) Subjects Treated With Tocilizumab (TCZ) Plus Tight Control Methotrexate (MTX) , TCZ Monotherapy or Tight Control MTX Monotherapy
Brief Summary: This randomized, double-blind, placebo-controlled study will compare the efficacy with regard to sustained remission and safety of tocilizumab and methotrexate, in combination or as monotherapy, in treatment-naïve patients with early rheumatoid arthritis. Patients will be randomized to receive either tocilizumab (8mg/kg iv every 4 weeks) plus weekly methotrexate (po in ascending doses), or tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or methotrexate plus placebo. Anticipated time on study treatment is 2 years, and target sample size is 300.


Options:
A: Arm Label: Methylprednisolone 80 mg; Type: EXPERIMENTAL; Interventions: Drug: Methylprednisolone 80 mg | Arm Label: Methylprednisolone 40 mg; Type: EXPERIMENTAL; Interventions: Drug: Methylprednisolone 40 mg | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Saline | Intervention Type: DRUG; Name: Methylprednisolone 80 mg; Assigned to Arm(s): Methylprednisolone 80 mg | Intervention Type: DRUG; Name: Methylprednisolone 40 mg; Assigned to Arm(s): Methylprednisolone 40 mg | Intervention Type: OTHER; Name: Saline; Assigned to Arm(s): Placebo
B: Arm Label: Conservative group; Type: EXPERIMENTAL; Interventions: Other: Conservative group | Arm Label: Surgical group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Surgical group | Intervention Type: OTHER; Name: Conservative group; Assigned to Arm(s): Conservative group | Intervention Type: PROCEDURE; Name: Surgical group; Assigned to Arm(s): Surgical group
C: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: Methylprednisolone 40 mg | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: Methylprednisolone 80 mg | Arm Label: C; Type: PLACEBO_COMPARATOR; Interventions: Drug: Sodium chloride | Intervention Type: DRUG; Name: Methylprednisolone 40 mg; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Methylprednisolone 80 mg; Assigned to Arm(s): B | Intervention Type: DRUG; Name: Sodium chloride; Assigned to Arm(s): C
D: Arm Label: Tocilizumab + Methotrexate; Type: EXPERIMENTAL; Interventions: Drug: methotrexate, Drug: tocilizumab [RoActemra/Actemra] | Arm Label: Tocilizumab + Placebo Methotrexate; Type: ACTIVE_COMPARATOR; Interventions: Drug: placebo MTX, Drug: tocilizumab [RoActemra/Actemra] | Arm Label: Methotrexate + Placebo Tocilizumab; Type: ACTIVE_COMPARATOR; Interventions: Drug: methotrexate, Drug: placebo TCZ | Intervention Type: DRUG; Name: methotrexate; Assigned to Arm(s): Methotrexate + Placebo Tocilizumab, Tocilizumab + Methotrexate | Intervention Type: DRUG; Name: placebo MTX; Assigned to Arm(s): Tocilizumab + Placebo Methotrexate | Intervention Type: DRUG; Name: placebo TCZ; Assigned to Arm(s): Methotrexate + Placebo Tocilizumab | Intervention Type: DRUG; Name: tocilizumab [RoActemra/Actemra]; Assigned to Arm(s): Tocilizumab + Methotrexate, Tocilizumab + Placebo Methotrexate

Answer: D