Maritati 2017.

Methods	Study design: open label parallel RCT Duration of study: December 1997 to June 2011 Duration of follow‐up: 24 months
Participants	Country: Italy Setting: single centre Inclusion criteria: diagnosis of clinically active systemic necrotizing vasculitis; aged 18 to 80 years; life‐expectancy > 1 year; written informed consent; randomisation performed only if GFR > 30 Number: treatment group 1 (38); treatment group 2 (33) Median age, IQR (years): treatment group 1 (52, 18 to 77); treatment group 2 (56, 36 to 71) Sex (M/F): treatment group 1 (19/19); treatment group 2 (17/16) Exclusion criteria: CrCl < 10 mL/min/1.73 m2; aminotransferase levels more than twice the upper limit of the normal range; HBsAg positivity; anti‐HCV Ig and HCV‐RNA positivity; HIV positivity; active malignancies; coexistence of connective tissue disease; prednisolone, CPA or MTX hypersensitivity; pregnancy
Interventions	Treatment group 1 MTX: 15 mg/week increased to 0.3 mg/kg/week Patients with eGFR of 30 to 50 mL/min/1.73 m2 received 75% of the full CPA dose and half of the full MTX dose Treatment group 2 CPA: 1.5 mg/kg/day orally; treatment continued for 12 months Co‐interventions Both groups received induction therapy with 3 IV pulses of 500 mg MP followed by oral prednisone and CPA. Oral prednisolone starting at 1mg/kg/day, gradually tapered to 5 mg at month 6 and oral CP dose was 2mg/kg/day
Outcomes	Relapse at 12 months, 18 and 24 months Major and minor relapses Change in eGFR Death Adverse events
Notes	Funding source: "The author(s) received no specific funding for this work"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer algorithm
Allocation concealment (selection bias)	High risk	Not performed
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	All patients accounted for
Selective reporting (reporting bias)	Unclear risk	All outcomes reported
Other bias	Low risk	Study appears free of other biases