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Thalidomide improves clinical remission in children with Crohn's disease
  1. Sophie Harbour1,
  2. Nick Brown2
  1. 1Neonatal Department, Princess Anne Hospital, Southampton, UK
  2. 2Paediatric Department, Salisbury District Hospital, Salisbury, UK
  1. Correspondence to Dr Sophie Harbour, Neonatal Department, Princess Anne Hospital, Southampton SO16 5YA, UK; sophieharbour{at}gmail.com

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Methods

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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