REMICADE treatment in the prevention of Crohn's disease recurrence

• Research type

  Research Study

• Full title

  Prospective, Multicentre, Randomised, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

• IRAS ID

  54087

• Contact name

  Simon Travis

• Sponsor organisation

  Janssen Biologics B.V.,

• Eudract number

  2010-018431-18

• ISRCTN Number

  Not Submitted

• Research summary

  Crohn??s disease is a chronic, recurring, inflammatory disease of the Gastro-Intestinal (GI) tract. Commonly, treatment for this disease involves the removal of parts of the intestine (ileocolonic resection). However, one study found that up to 70% of people undergoing such an operation have evidence of recurrence of the disease within a year of the operation, when examined with an endoscope. There is currently no cure for Crohn??s disease and a range of therapies have been used to prevent the recurrence of post-operative Crohn??s disease (disease recurrence after an operation), including mesalamine, an anti-inflammatory drug, corticosteroids like budesonide, and certain nitroimidazole antibiotics. However, none of these treatments has proved particularly successful at preventing the recurrence of post-operative Crohn??s disease. Infliximab (REMICADE©) is an artificial antibody. An antibody is a protein produced by the immune system that fights infections by binding to other molecules. Infliximab binds to Tumour Necrosis Factor alpha (TNFa) receptors, thereby inhibiting the action of TNFa molecules. There is evidence that TNFa molecules form part of a chemical signal which causes the inflammation characterising Crohn??s disease. Treatment with infliximab has also been shown to repair the lining of the intestine in persons with active Crohn??s disease. Therefore, if used in post-operative care, infliximab could prevent the recurrence of Crohn??s disease, as detected by an endoscope. Although infliximab is currently approved for the treatment of Crohn??s disease, the Sponsor of this study, Centocor B.V., would like to conduct a research study involving 290 participants who have undergone an ileocolonic resection, across 150 sites, worldwide, to investigate whether post-operative treatment with infliximab is more effective than treatment with a placebo (a identical ??dummy? drug, containing no active compounds) in preventing the recurrence of Crohn??s disease. Participant involvement in this study is expected to last a maximum of 210 weeks (approximately 4 years). On joining the study participants will be randomly assigned to treatment with either the study drug or a placebo. Treatments will be administered as an infusion once every 8 weeks, for 200 weeks.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  10/H0720/60

• Date of REC Opinion

  11 Aug 2010

• REC opinion

  Further Information Favourable Opinion