Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis
Brief Summary: This is a phase III, randomized, controlled, double-blind, parallel group, international study in approximately 750 patients with active Rheumatoid Arthritis (RA) who are naive to Methotrexate (MTX) therapy. Rheumatoid Factor (RF)-positive and RF-negative patients will be enrolled and will be allocated equally between 3 treatment arms.


Options:
A: Arm Label: Rituximab (0.5 g x 2) + Methotrexate; Type: EXPERIMENTAL; Interventions: Drug: folate, Drug: methotrexate, Drug: methylprednisolone, Drug: rituximab | Arm Label: Rituximab (1.0 g x 2) + Methotrexate; Type: EXPERIMENTAL; Interventions: Drug: folate, Drug: methotrexate, Drug: methylprednisolone, Drug: rituximab | Arm Label: Placebo + Methotrexate; Type: PLACEBO_COMPARATOR; Interventions: Drug: folate, Drug: methotrexate, Drug: methylprednisolone, Drug: placebo | Intervention Type: DRUG; Name: folate; Assigned to Arm(s): Placebo + Methotrexate, Rituximab (0.5 g x 2) + Methotrexate, Rituximab (1.0 g x 2) + Methotrexate | Intervention Type: DRUG; Name: methotrexate; Assigned to Arm(s): Placebo + Methotrexate, Rituximab (0.5 g x 2) + Methotrexate, Rituximab (1.0 g x 2) + Methotrexate | Intervention Type: DRUG; Name: methylprednisolone; Assigned to Arm(s): Placebo + Methotrexate, Rituximab (0.5 g x 2) + Methotrexate, Rituximab (1.0 g x 2) + Methotrexate | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo + Methotrexate | Intervention Type: DRUG; Name: rituximab; Assigned to Arm(s): Rituximab (0.5 g x 2) + Methotrexate, Rituximab (1.0 g x 2) + Methotrexate
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: methotrexate, Drug: rituximab | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: methotrexate, Drug: rituximab, Drug: corticosteroids | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: methotrexate, Drug: rituximab, Drug: corticosteroids | Arm Label: 4; Type: EXPERIMENTAL; Interventions: Drug: methotrexate, Drug: rituximab | Arm Label: 5; Type: EXPERIMENTAL; Interventions: Drug: methotrexate, Drug: rituximab, Drug: corticosteroids | Arm Label: 6; Type: EXPERIMENTAL; Interventions: Drug: methotrexate, Drug: rituximab, Drug: corticosteroids | Arm Label: 7; Type: PLACEBO_COMPARATOR; Interventions: Drug: methotrexate, Drug: placebo | Arm Label: 8; Type: PLACEBO_COMPARATOR; Interventions: Drug: methotrexate, Drug: corticosteroids, Drug: placebo | Arm Label: 9; Type: PLACEBO_COMPARATOR; Interventions: Drug: methotrexate, Drug: corticosteroids, Drug: placebo | Intervention Type: DRUG; Name: methotrexate; Assigned to Arm(s): 1, 2, 3, 4, 5, 6, 7, 8, 9 | Intervention Type: DRUG; Name: rituximab; Assigned to Arm(s): 1, 2, 3, 4, 5, 6 | Intervention Type: DRUG; Name: corticosteroids; Assigned to Arm(s): 2, 3, 5, 6, 8, 9 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 7, 8, 9
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: rituximab [MabThera/Rituxan] | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: rituximab [MabThera/Rituxan] | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: rituximab [MabThera/Rituxan] | Intervention Type: DRUG; Name: rituximab [MabThera/Rituxan]; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: rituximab [MabThera/Rituxan]; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: rituximab [MabThera/Rituxan]; Assigned to Arm(s): 3
D: Arm Label: Rituximab + methotrexate (Group A); Type: EXPERIMENTAL; Interventions: Drug: Rituximab, Drug: Methotrexate, Drug: Methylprednisone, Biological: C. albicans, Biological: Tetanus toxoid adsorbed booster vaccine, Biological: 23-valent pneumococcal polysaccharide vaccine, Biological: Keyhole limpet hemocyanin | Arm Label: Methotrexate (Group B); Type: ACTIVE_COMPARATOR; Interventions: Drug: Methotrexate, Biological: C. albicans, Biological: Tetanus toxoid adsorbed booster vaccine, Biological: 23-valent pneumococcal polysaccharide vaccine, Biological: Keyhole limpet hemocyanin | Intervention Type: DRUG; Name: Rituximab; Assigned to Arm(s): Rituximab + methotrexate (Group A) | Intervention Type: DRUG; Name: Methotrexate; Assigned to Arm(s): Methotrexate (Group B), Rituximab + methotrexate (Group A) | Intervention Type: DRUG; Name: Methylprednisone; Assigned to Arm(s): Rituximab + methotrexate (Group A) | Intervention Type: BIOLOGICAL; Name: C. albicans; Assigned to Arm(s): Methotrexate (Group B), Rituximab + methotrexate (Group A) | Intervention Type: BIOLOGICAL; Name: Tetanus toxoid adsorbed booster vaccine; Assigned to Arm(s): Methotrexate (Group B), Rituximab + methotrexate (Group A) | Intervention Type: BIOLOGICAL; Name: 23-valent pneumococcal polysaccharide vaccine; Assigned to Arm(s): Methotrexate (Group B), Rituximab + methotrexate (Group A) | Intervention Type: BIOLOGICAL; Name: Keyhole limpet hemocyanin; Assigned to Arm(s): Methotrexate (Group B), Rituximab + methotrexate (Group A)

Answer: A