CYCAZAREM 2003.

Methods	Study design: parallel RCT Duration of study: not reported Duration of follow‐up: 18 months
Participants	Countries: 11 European countries Setting: multicentre (39 sites) Inclusion criteria: diagnosis of WG, MPA or kidney limited vasculitis. Renal involvement, other threatened loss of function of vital organ, or both. ANCA positivity. ANCA negative patients enrolled with biopsy evidence of vasculitis Number: treatment group (79); control group (76) Mean age, range (years): treatment group (59, 20 to 77); control group (57, 20 to 76) Sex (M/F): treatment group (33/46); control group (40/36) Exclusion criteria: cytotoxic drug in previous year; other multisystem autoimmune disease; hepatitis B e antigenaemia; hepatitis C; HIV infection; SCr > 500 μmol/L; cancer; pregnancy; aged < 18 years or >75 years
Interventions	Treatment group CPA: 1.5 mg/kg/day from remission Switched to AZA (2 mg/kg/day) 12 months after study entry Control group After remission induction AZA: 2 mg/kg/day Prednisolone: 10 mg/day Co‐interventions (both groups) Remission induction with oral CPA (2 mg/kg/day) and prednisolone (1 mg/kg/day) tapered to 0.25 mg/kg/day by 12 weeks From 12 months both groups received AZA (1.5 mg/kg/day) and prednisolone (7.5 mg/day)
Outcomes	Relapse by 18 months Side effects including leukopenia and infections.
Notes	Stopping point: 18 months after study entry Funding source: reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was performed centrally with the use of permuted blocks of four within each country, with stratification according to diagnosis."
Allocation concealment (selection bias)	Low risk	Not reported, however assumed to be performed centrally
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgement
Incomplete outcome data (attrition bias) All outcomes	Low risk	All patients accounted for
Selective reporting (reporting bias)	Low risk	All outcomes reported
Other bias	Low risk	Supported by contracts (BMH1‐CT93‐1078, CIPD‐CT94‐0307, BMH4‐CT97‐2328, and IC20‐CT97‐0019) with the European Union