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Study design: Double-blinded, placebo controlled, randomised control trial.
Setting: Six paediatric tertiary care centres in Italy between August 2008 and September 2012.
Patients: 56 children with Crohn's disease which was active despite immunosuppressive treatment.
Intervention: Thalidomide (1.5–2.5 mg/kg/day) or placebo once daily for 8 weeks. Open-label extension meant children who received the placebo and did not respond were given thalidomide for 8 weeks. All responders were given an additional course of at least 52 weeks.
Primary outcome: Clinical remission at 8 weeks, measured using the Paediatric Crohn's Disease Activity Index and PCDAI score at 4 weeks and 8 weeks.
Follow-up period: Four weeks and 8 weeks.
Main results: More children (13/28 (46.4%)) who received thalidomide achieved clinical remission than those who received the placebo (3/26 (11.5%)), (RR 4.0 (95% CI 1.2 to 12.5, …
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