Hommes 2008.

Methods	Randomised clinical trial.
Participants	Country: The Netherlands. Number randomised: 10. Post‐randomisation drop‐outs: 3 (30%). Revised sample size: 7. Mean age: 45 years. Females: 4 (57.1%). Separate data for the subgroup with ulcerative colitis: no. Inclusion criteria: Cholangiographic or histological diagnosis of primary sclerosing cholangitis. Age older than 18 years. Alkaline phophatase at least 2 times the upper limit of normal. Exclusion criteria: Crohn's disease activity index greater than 350. Evidence of secondary sclerosing cholangitis. Evidence of other liver disease. Previous treatment with infliximab, treatment with any other agent targeted at tumour necrosis factor (TNF) reduction within 3 months of screening, treatment with immunosuppressive or anti‐inflammatory medication other than mesalazine derivatives. Unstable on treatment with UDCA. Follow‐up: 13 months.
Interventions	Participants were randomly assigned to 1 of 2 groups. Group 1: infliximab (5 mg/kg) at weeks 0, 2, 6, 12, 18, and 24 (n = 4). Group 2: placebo at weeks 0, 2, 6, 12, 18, and 24 (n = 3).
Outcomes	1. Proportion of participants with severe adverse events 2. Number of severe adverse events.
Notes	Reasons for post‐randomisation drop‐out: Liver transplantation (1 participant in the placebo group). Dominant stenosis requiring stenting (1 participant in the infliximab group). Colorectal cancer (1 participant in the infliximab group).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Patients were randomised in a 2:1 ratio to receive infliximab or placebo at weeks 0, 2, 6,12, 18, and 24". Comment: Additional details were not available.
Allocation concealment (selection bias)	Unclear risk	Comment: This information was not available.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Infliximab was supplied in 20‐mL vials containing 100mg of the lyophilized concentrate; placebo was identically formulated. The infusion solution was administered by blinded investigators using an infusion set".
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Infliximab was supplied in 20‐mL vials containing 100mg of the lyophilized concentrate; placebo was identically formulated. The infusion solution was administered by blinded investigators using an infusion set".
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: Post‐randomisation drop‐outs may be related to the treatment that participants received.
Selective reporting (reporting bias)	High risk	Comment: No published protocol was available; mortality was not reported.
For‐profit bias	High risk	Quote: "Daan Hommes has served as consultant and speaker for both Centocor and Schering Plough. Supported by a Research Grant from Centocor, Inc (Malvern, USA)". Comment: The trial was funded by a party with vested interest in the results (this company produces infliximab).
Other bias	Low risk	Comment: no other bias.