Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha Therapies
Brief Summary: This study will assess the safety and efficacy of rituximab combined with MTX in participants with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor Necrosis (TNF) alpha therapy. The anticipated time in the study is up to 2 years and the target sample size is 500 participants. Eligible participants may receive re-treatment with rituximab under a separate protocol WA17531.


Options:
A: Arm Label: Double-blind/Open Label Rituximab; Type: EXPERIMENTAL; Interventions: Biological: IDEC-C2B8 (rituximab), Drug: Methotrexate, Drug: Etanercept, Drug: Adalimumab, Drug: Methylprednisolone, Dietary Supplement: Folate | Arm Label: Double-blind Placebo/Open Label Rituximab; Type: OTHER; Interventions: Drug: Placebo, Drug: Methotrexate, Drug: Etanercept, Drug: Adalimumab, Drug: Methylprednisolone, Dietary Supplement: Folate | Intervention Type: BIOLOGICAL; Name: IDEC-C2B8 (rituximab); Assigned to Arm(s): Double-blind/Open Label Rituximab | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Double-blind Placebo/Open Label Rituximab | Intervention Type: DRUG; Name: Methotrexate; Assigned to Arm(s): Double-blind Placebo/Open Label Rituximab, Double-blind/Open Label Rituximab | Intervention Type: DRUG; Name: Etanercept; Assigned to Arm(s): Double-blind Placebo/Open Label Rituximab, Double-blind/Open Label Rituximab | Intervention Type: DRUG; Name: Adalimumab; Assigned to Arm(s): Double-blind Placebo/Open Label Rituximab, Double-blind/Open Label Rituximab | Intervention Type: DRUG; Name: Methylprednisolone; Assigned to Arm(s): Double-blind Placebo/Open Label Rituximab, Double-blind/Open Label Rituximab | Intervention Type: DIETARY_SUPPLEMENT; Name: Folate; Assigned to Arm(s): Double-blind Placebo/Open Label Rituximab, Double-blind/Open Label Rituximab
B: Arm Label: Placebo Plus Methotrexate; Type: PLACEBO_COMPARATOR; Interventions: Drug: Methotrexate, Other: Placebo | Arm Label: Rituximab plus Methotrexate; Type: EXPERIMENTAL; Interventions: Drug: MabThera/Rituxan, Drug: Methotrexate | Intervention Type: DRUG; Name: MabThera/Rituxan; Assigned to Arm(s): Rituximab plus Methotrexate | Intervention Type: DRUG; Name: Methotrexate; Assigned to Arm(s): Placebo Plus Methotrexate, Rituximab plus Methotrexate | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo Plus Methotrexate
C: 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)
D: 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

Answer: B