Schreiber 2000.

Methods	Multicenter, randomised, double‐blind, placebo‐controlled clinical trial February 1996 ‐ October 1997
Participants	N = 329, Age: adults Diagnosis: therapy ‐ refractory Crohn’s disease
Interventions	Intervention: s. c., different doses of rhuIL‐10: 1 ųg/kg, 18% [9.6 ‐ 29.2], 4 ųg/kg, 20% [11.3 ‐ 32.2], 8 ųg/kg, 20% [11.1 ‐ 31.8], 20 ųg/kg, 28% [18 ‐ 40.7] Control: placebo, 18% [9.6‐29.6] Duration: 28 days
Outcomes	Primary outcomes: 1. Clinical remission, defined as a CDAI score lower than 150 and a decrease from baseline CDAI of more than 100 points. Secondary outcomes: 1. Clinical improvement, defined as a decrease from baseline CDAI of more than 100 points 2. Endoscopic improvement 3. Quality of life measured by IBD questionnaire and SF‐36 health survey 4. Effect of treatment on proinflammatory transcription factor activity at the end of treatment period.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated sequence, as confirmed by a researcher involved in the execution of the trial, not described in the report (quote: 'patients were randomized'). Stratification according to steroid dose received, and use of immunosuppressive agents.
Allocation concealment (selection bias)	Low risk	Quote: 'Central randomization was used, ...'
Blinding (performance bias and detection bias) All outcomes	Low risk	Double blinding properly conducted, as confirmed by a researcher involved in the execution of the trial. After 50 patients completed the treatment safety was assessed in a blinded fashion by an independent data monitoring committee. After treatment of 151 efficacy was assessed in an unblinded fashion.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	329 patients were randomized (263 to rhuIL‐10 and 66 to placebo). 45 patients discontinued the treatment for the following reasons (distribution by groups not reported): Adverse events: 30 Treatment failure: 9 Ineligibility: 3 (these patients were randomised but did not receive the treatment) Patient preference: 2 Death: 1