Jayne 2000.

Methods	Study design: parallel RCT Duration of study: not reported Duration of follow‐up: 12 months
Participants	Country: UK Setting: multicentre (5) Inclusion criteria: prior diagnosis of WG or MPA; ANCA positivity at diagnosis; active vasculitis with a requirement for further therapy; at least 2 months treatment with prednisolone and CPA or AZA; ≥ 18 years Number: treatment group (17); control group (17) Mean age ± SD (years): treatment group (57.1 ± 10.5); control group (50.4 ± 19.9) Sex (M/F): treatment group (10/7); control group (9/8) Exclusion criteria: IVIg in previous 3 months; history of anaphylaxis to matched blood products; selective IgA deficiency; RPGN (20% rise in SCr in 2 weeks) or pulmonary haemorrhage
Interventions	Initial treatment (both groups) CPA and prednisolone for remission induction then AZA for maintenance then a 2‐week observation period Treatment group IVIg: 0.4 g/kg/day for 5 days Control group Placebo (identical injections) for 5 days
Outcomes	Primary outcome Treatment response. BVAS reduction of 50% between entry and 3 months Secondary outcomes Fall in BVAS, CRP and ANCA Relapse at 3 months Reduction in immunosuppressive drug doses Adverse effects
Notes	Funding source: "This trial was supported by a grant and provision of trial medication from Novartis Pharmaceuticals UK."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Randomisation and distribution of trial medication was centrally controlled by Novartis UK"
Allocation concealment (selection bias)	Low risk	Medication distributed by Novartis UK
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"patients and physicians were blinded to the treatment limb"
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	Study and review outcomes reported
Other bias	High risk	Funding source: Novartis