Skip to main content
. 2018 May 12;2018(5):CD012540. doi: 10.1002/14651858.CD012540.pub2

Wenzl 2015.

Methods Randmized, double‐blind, placebo‐controlled withdrawal trial (N = 52)
Participants CD patients in stable clinical remission (CDAI < 150) on azathioprine for > 4 years
Interventions 1:1 randomization ratio
Group 1: placebo (n = 26)
Group 2: azathioprine at dose prior to study entry (n = 26)
Follow‐up duration: 24 months
Outcomes Primary outcome: Time interval between first intake of the study drug and disease relapse
Secondary outcomes: Disease activity (CDAI), quality of life, and laboratory parameters associated with active disease (CRP, serum hemoglobin, serum albumin, and platelet count)
Notes Slow recruitment led to premature cessation of the study
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization tables were used according to a 1:1 ratio
Allocation concealment (selection bias) Low risk Centralized randomization was performed
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blind: medicine was provided in identical‐appearing tablets
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not adequately described
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Drop‐outs were balanced across treatment groups
19/26 in the azathioprine group completed the study compared to 23/26 in the placebo group
Selective reporting (reporting bias) Low risk All expected outcomes were reported
Other bias Unclear risk Premature stopping of the trial due to slow enrolment.