Crohn's Disease Maintenance Trial

• Research type

  Research Study

• Full title

  A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease.

• IRAS ID

  68219

• Contact name

  Drisatish Keshav

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2010-022383-12

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of this study is to test the safety and efficacy of GSK1605786A in maintaining remission in Crohn's Disease. Subjects who have achieved response and/or remission in the induction study CCX114151 are eligible. patients with Crohn's Disease can have high levels of Lymphocytes (a type of White Blood Cell) in theGastrointestinaltractwhich causes inflammation. GSK1605786A is an oral drug which works by blocking these Lymphocytes from reaching their target organ in the intestine. Suitable subjects willreceive 52 weeks of treatment with one of 2 doses of GSK1605786A (500 mg once daily or 500 mg twice daily) or placebo (capsule that does not contain study drug).treatments will be allocated randomly, and neither the patient nor their doctor will know which treatment is being given. This may not be the same treatment as received in the Induction study. patients will attend fortnightly for 12 weeks and then monthlyfor blood tests (including pregnancy tests for women who can become pregnant) and will see a doctor every 4 weeks for the 1st 3 months and then every 8 weeks to the end of treatment. Stool samples, to assess Crohn's disease, will be collected at two visits Other tests will include a physical examination(including heart monitoring and an assessment of any openin's in the skin that are known as fistulas). Subjects will be also be asked to answer questions via written questionnaires and an automated telephone system. Subjects completingthe study are eligible foran open-label study with GSK1605786A.Subjects not participating in the open-label study will require a follow-up visit 4 weeks after the end of treatment.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  11/H0606/6

• Date of REC Opinion

  24 Feb 2011

• REC opinion

  Further Information Favourable Opinion