An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease
Status:
Terminated
Trial end date:
2013-10-17
Target enrollment:
Participant gender:
Summary
This is a multi-centre, randomised, double-blind, active treatment, parallel group induction
study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive
one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for
12 weeks. The primary objective of the study is to induce clinical response (Crohn's Disease
Activity Index [CDAI] decrease from baseline of at least 100 points) and/or remission (CDAI
score less than 150) with GSK1605786A at Week 12 in subjects with active Crohn's disease to
qualify subjects for enrolment into a 52 week maintenance study (CCX114157). Secondary
objectives will include assessment of the safety and evaluation of the efficacy in induction
of clinical response or remission. Safety will be assessed by recording of adverse events and
assessment of changes in clinical laboratory parameters, vital signs and electrocardiogram.
Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes
assessments will include changes in Inflammatory Bowel Disease Questionnaire, SF-36, EQ-5D,
and Work Productivity and Activity Impairment-Crohn's Disease.