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 |
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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) |
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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. |