Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Treatment of ANCA-Associated Vasculitides : Corticosteroids and Pulse Cyclophosphamide Followed by Maintenance Therapy With Methotrexate or Azathioprine: a Prospective Multicenter Randomized Trial
Brief Summary: Remission of ANCA-associated vasculitis can be obtained in approximately 80% of the patients with a combination of corticosteroids and cyclophosphamide. However, relapses are frequent. This point warrants the prescription of a maintenance treatment with a less toxic immunosuppressant for several months to years. The optimal drug in this indication is not determine. We decided therefore to compare the 2 most used drugs in this indication. Induction therapy consists in the combination of corticosteroids and intravenous cyclophosphamide pulses. Corticotherapy consisted first in one daily methylprednisolone pulse, for 1 to 3 days, followed by oral prednisolone at the dose of 1 mg/kg/d for 3 weeks, then progressively tapered and stopped at the 18th month from the diagnosis. Cyclophosphamide is administered every 2 weeks for the first 3 bolus (0.6 g/m2 - D1, 15 and 30), then every 3 weeks (0.7 g/m2). Once remission is achieved, patients receive 3 additional bolus (0.7 g/m2). At that time, patients are randomized for a maintenance treatment with azathioprine (2 mg/kg/d, orally) or oral methotrexate (starting at the dose of 0.3 mg/kg/wk, then progressively increased every weeks by 2.5mg, if necessary, to a maximum and optimal dose of 25 mg/wk) for 12 months.


Options:
A: Arm Label: Rituximab; Type: EXPERIMENTAL; Interventions: Drug: Rituximab plus cyclophosphamide placebo (rituximab group), Drug: Methylprednisolone (or other glucocorticoid), Drug: Prednisone | Arm Label: Control Group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Cyclophosphamide plus rituximab placebo (control group), Drug: Azathioprine, Drug: Methylprednisolone (or other glucocorticoid), Drug: Prednisone | Intervention Type: DRUG; Name: Rituximab plus cyclophosphamide placebo (rituximab group); Assigned to Arm(s): Rituximab | Intervention Type: DRUG; Name: Cyclophosphamide plus rituximab placebo (control group); Assigned to Arm(s): Control Group | Intervention Type: DRUG; Name: Azathioprine; Assigned to Arm(s): Control Group | Intervention Type: DRUG; Name: Methylprednisolone (or other glucocorticoid); Assigned to Arm(s): Control Group, Rituximab | Intervention Type: DRUG; Name: Prednisone; Assigned to Arm(s): Control Group, Rituximab
B: Arm Label: mycophenolate mofetil; Type: EXPERIMENTAL; Interventions: Drug: mycophenolate mofetil | Arm Label: cyclophosphamide; Type: ACTIVE_COMPARATOR; Interventions: Drug: cyclophosphamide | Intervention Type: DRUG; Name: mycophenolate mofetil; Assigned to Arm(s): mycophenolate mofetil | Intervention Type: DRUG; Name: cyclophosphamide; Assigned to Arm(s): cyclophosphamide
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Procedure: Plasma exchange | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Intravenous methyl prednisolone, Drug: Methyl prednisolone | Intervention Type: PROCEDURE; Name: Plasma exchange; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Intravenous methyl prednisolone; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Methyl prednisolone; Assigned to Arm(s): 2
D: Intervention Type: DRUG; Name: Azathioprine: 2 mg/kg/day; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: methotrexate 0.3 mg/kg/week, to a maximum and optimal dose of 25 mg/week; Assigned to Arm(s): N/A

Answer: D