Open-Label Extension Study of GSK1605786A
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: GSK1605786A
Intervention description: 500 milligrams twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 399.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GSK1605786A; Inflammatory Bowel Disease; Crohn's disease; long-term treatment; quality of life; CCR9 antagonist

Summary:

      An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice
      daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous
      GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157
      (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment
      change may be eligible to participate. The primary objective is to evaluate the safety of
      GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters,
      vital signs and electrocardiogram. Secondary objectives will include assessments of
      effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will
      include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and
      Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous participation in a GSK-sponsored study with GSK1605786A

          -  Written informed consent prior to any study-specific procedures

          -  Female subjects: To be eligible, females of child-bearing potential must be sexually
             inactive or commit to consistent and correct use of a contraceptive method of birth
             control with less than 1% failure rate

        Exclusion Criteria:

          -  If female, is pregnant, has a positive pregnancy test or is breast-feeding, or is
             planning to become pregnant

          -  Subjects with known or suspected coeliac disease or a positive screening test for
             anti-tissue transglutaminase antibodies should have been excluded from enrolment into
             any induction study. Subjects in whom a diagnosis of coeliac disease is subsequently
             suspected should be tested for anti-tissue transglutaminase antibodies and excluded or
             withdrawn from the study upon positive test result

          -  Fixed symptomatic stenoses or strictures of small bowel or colon

          -  Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the
             study period

          -  Current sepsis or infections requiring intravenous antibiotic therapy greater than 2
             weeks

          -  Evidence of hepatic dysfunction or viral hepatitis

          -  Subjects who have demonstrated safety or tolerability issues during participation in a
             previous study with GSK1605786A which, in the opinion of the investigator, was
             possibly related to study treatment and poses an unacceptable risk to the subject.