Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Open-Label, Prospective Study of the Safety of Rituximab in Combination With Other Disease-Modifying Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis
Brief Summary: This is a Phase III, open-label study of a total of approximately 560 subjects with active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Enrollment in the study was conducted in two stages. In Stage I of the study, approximately 400 subjects receiving non-biological DMARDs (with the exception of methotrexate \[MTX\] monotherapy or MTX and leflunomide combination therapy) were enrolled. In Stage II of the study, approximately 160 subjects receiving a Federal Drug Administration-approved biological DMARD at the time of screening were enrolled.


Options:
A: 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)
B: Arm Label: Rituximab 1000 mg (Stage I patients); Type: EXPERIMENTAL; Interventions: Drug: Rituximab, Drug: Anti-inflammatory drugs | Arm Label: Rituximab 500 mg (Stage II patients); Type: EXPERIMENTAL; Interventions: Drug: Rituximab, Drug: Anti-inflammatory drugs | Intervention Type: DRUG; Name: Rituximab; Assigned to Arm(s): Rituximab 1000 mg (Stage I patients), Rituximab 500 mg (Stage II patients) | Intervention Type: DRUG; Name: Anti-inflammatory drugs; Assigned to Arm(s): Rituximab 1000 mg (Stage I patients), Rituximab 500 mg (Stage II patients)
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: MabThera/Rituxan; Type: EXPERIMENTAL; Interventions: Drug: methotrexate, Drug: rituximab [MabThera/Rituxan] | Intervention Type: DRUG; Name: methotrexate; Assigned to Arm(s): MabThera/Rituxan | Intervention Type: DRUG; Name: rituximab [MabThera/Rituxan]; Assigned to Arm(s): MabThera/Rituxan

Answer: B