GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease
Status:
Terminated
Trial end date:
2013-10-23
Target enrollment:
Participant gender:
Summary
A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of
two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission
over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the
Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response
(CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK
sponsored induction study. The primary endpoint will be proportion of subjects in remission
at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical
laboratory parameters including liver function tests, vital signs and electrocardiogram.
Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes
assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2,
EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and disability.