GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease (SHIELD-2)

This study has been terminated.
(This study was terminated due to the lack of efficacy of GSK1605786A in Crohn's disease based on the results of Study CCX114151.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01316939
First received: March 3, 2011
Last updated: March 13, 2014
Last verified: March 2014

March 3, 2011
March 13, 2014
May 2011
September 2013   (final data collection date for primary outcome measure)
Remission (CDAI score less than 150 points) [ Time Frame: At both Weeks 28 and 52 ] [ Designated as safety issue: No ]
Proportion of subjects in clinical remission (CDAI score less than 150 points)
Same as current
Complete list of historical versions of study NCT01316939 on ClinicalTrials.gov Archive Site
  • Corticosteroid-free remission [ Time Frame: At both Weeks 28 and 52 ] [ Designated as safety issue: No ]
    Proportion of subjects in clinical remission (CDAI score less than 150 points) and not taking corticosteroids
  • Remission in subjects who were in remission at baseline [ Time Frame: At both Weeks 28 and 52 ] [ Designated as safety issue: No ]
    Proportion of subjects in clinical remission (CDAI score less than 150 points) in subjects who were in remission at baseline
  • Remission at end of treatment [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Proportion of subject in clinical remission (CDAI score less than 150 points) at end of treatment
  • Clinical response (CDAI decrease of at least 100 points) [ Time Frame: At both Weeks 28 and 52 ] [ Designated as safety issue: No ]
    Proportion of subjects with clinical response (CDAI decrease of at least 100 points)
  • Induction of remission in subjects who were not in remission at baseline [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Time to induction of remission in subjects who were not in remission at baseline
  • Change from baseline in CDAI score [ Time Frame: Weeks 4, 8, 12, 20, 28, 36, 44, 52 ] [ Designated as safety issue: No ]
    Change from baseline in CDAI score at various timepoints over the treatment period
  • Safety outcomes [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline in safety measures and incidence of adverse events and serious adverse events
  • Health outcomes [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline in quality of life measures
  • Biomarkers [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline in C-reactive protein and faecal calprotectin
Same as current
Not Provided
Not Provided
 
GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease
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

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.

This is a multi-centre, randomised, placebo-controlled, double-blind parallel group study in adult subjects with Crohn's disease who previously achieved clinical response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior Phase III induction study (Study CCX114151 or another GSK sponsored induction study). Subjects will be randomised to 52 weeks of oral treatment with GSK1605786A 500 mg once daily or 500 mg twice daily or placebo. Subjects who are receiving concomitant corticosteroids at entry will undergo dose tapering following a defined schedule. Subjects who complete the treatment period may be eligible to enter an open-label extension study. Subjects who experience disease worsening and require additional (rescue) treatment will be withdrawn and may be eligible to enter the open-label study. Subjects who do not enter the open-label study must complete a follow-up assessment 4 weeks after completion of treatment. Approximately 756 subjects will be enrolled.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Crohn's Disease
  • Drug: GSK1605786A
    GSK1605786A 500 milligrams once daily
  • Drug: Placebo
    Placebo
  • Drug: GSK1605786A
    GSK1605786A 500 milligrams twice daily
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: GSK1605786A
    500 milligrams once daily or twice daily
    Interventions:
    • Drug: GSK1605786A
    • Drug: GSK1605786A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
229
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects achieving clinical response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) upon completion of treatment in Study CCX114151 or another GSK sponsored induction study
  • Written informed consent prior to any CCX114157 specific study procedures
  • Females of child-bearing potential must be sexually inactive or commit to use of consistent and correct use of contraceptive methods with a failure rate of less than 1 percent
  • Stable doses of Crohn's disease medications
  • Subjects on corticosteroids at entry must be willing to undergo corticosteroid dose taper during the study

Exclusion Criteria:

  • If female, is pregnant, has a positive pregnancy test or is breast-feeding
  • Subjects with known or suspected coeliac disease or a positive screening test (anti-tissue transglutaminase antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should have this excluded with testing for anti-tissue transglutaminase antibodies prior to enrolment into the maintenance study.
  • Known or suspected fixed symptomatic small bowel stricture
  • Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period
  • Current sepsis or infections requiring intravenous antibiotic therapy for greater than 2 weeks
  • Evidence of hepatic dysfunction, viral hepatitis, or liver function abnormalities
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan,   United States,   Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Chile,   Czech Republic,   Denmark,   Estonia,   France,   Germany,   Hong Kong,   Hungary,   Israel,   Italy,   United Kingdom,   Korea, Republic of,   Netherlands,   New Zealand,   Norway,   Poland,   Portugal,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   Ukraine
 
NCT01316939
114157, 2010-022383-12
Yes
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP