Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial.
Brief Summary: The Systemic Necrotizing Vasculitides (SNV) encompass a group of rare diseases which include Wegener's Granulomatosis (WG), Churg-Strauss Syndrome (CSS), Microscopic polyangiitis (MPA)and Polyarteritis nodosa (PAN). Common histological findings are inflammation with fibrinoid necrosis of the small vessels and sporadic or absent immune-deposits. The gold standard therapy for SNV is currently represented by the association of Cyclophosphamide and Prednisone. The limits of this approach are the high frequency of recurrent disease and an increased incidence of malignancy and infections. The aim of the present study is to compare the efficacy of Methotrexate vs Cyclophosphamide for Remission Maintenance in SNV.


Options:
A: Arm Label: Rituximab infusion according biological parameters; Type: EXPERIMENTAL; Interventions: Drug: Rituximab (Arm B) | Arm Label: Systematic rituximab infusion; Type: ACTIVE_COMPARATOR; Interventions: Drug: Rituximab (Arm A) | Intervention Type: DRUG; Name: Rituximab (Arm B); Assigned to Arm(s): Rituximab infusion according biological parameters | Intervention Type: DRUG; Name: Rituximab (Arm A); Assigned to Arm(s): Systematic rituximab infusion
B: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: Cyclophosphamide | Arm Label: B; Type: EXPERIMENTAL; Interventions: Drug: Methotrexate | Intervention Type: DRUG; Name: Methotrexate; Assigned to Arm(s): B | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): A
C: Arm Label: Placebo plus azathioprine; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo, Drug: Azathioprine | Arm Label: Belimumab 10 mg/kg plus azathioprine; Type: EXPERIMENTAL; Interventions: Biological: Belimumab 10 mg/kg, Drug: Azathioprine | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo plus azathioprine | Intervention Type: BIOLOGICAL; Name: Belimumab 10 mg/kg; Assigned to Arm(s): Belimumab 10 mg/kg plus azathioprine | Intervention Type: DRUG; Name: Azathioprine; Assigned to Arm(s): Belimumab 10 mg/kg plus azathioprine, Placebo plus azathioprine
D: Arm Label: Plasma Exchange with Standard Glucocorticoids; Type: EXPERIMENTAL; Interventions: Procedure: Plasma Exchange, Drug: Glucocorticoids [Standard Dose] | Arm Label: No Plasma Exchange with Standard Glucocorticoids; Type: ACTIVE_COMPARATOR; Interventions: Other: No Plasma Exchange, Drug: Glucocorticoids [Standard Dose] | Arm Label: Plasma Exchange with Reduced-Dose Glucocorticoids; Type: EXPERIMENTAL; Interventions: Procedure: Plasma Exchange, Drug: Glucocorticoids [Reduced Dose] | Arm Label: No Plasma Exchange with Reduced-Dose Glucocorticoids; Type: ACTIVE_COMPARATOR; Interventions: Other: No Plasma Exchange, Drug: Glucocorticoids [Reduced Dose] | Intervention Type: PROCEDURE; Name: Plasma Exchange; Assigned to Arm(s): Plasma Exchange with Reduced-Dose Glucocorticoids, Plasma Exchange with Standard Glucocorticoids | Intervention Type: OTHER; Name: No Plasma Exchange; Assigned to Arm(s): No Plasma Exchange with Reduced-Dose Glucocorticoids, No Plasma Exchange with Standard Glucocorticoids | Intervention Type: DRUG; Name: Glucocorticoids [Standard Dose]; Assigned to Arm(s): No Plasma Exchange with Standard Glucocorticoids, Plasma Exchange with Standard Glucocorticoids | Intervention Type: DRUG; Name: Glucocorticoids [Reduced Dose]; Assigned to Arm(s): No Plasma Exchange with Reduced-Dose Glucocorticoids, Plasma Exchange with Reduced-Dose Glucocorticoids

Answer: B