Open-Label Extension Study of GSK1605786A (SHIELD-3)

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:
NCT01318993
First received: March 3, 2011
Last updated: March 13, 2014
Last verified: March 2014

March 3, 2011
March 13, 2014
April 2011
September 2013   (final data collection date for primary outcome measure)
Number of subjects with adverse events and serious adverse events [ Time Frame: Over 112 weeks ] [ Designated as safety issue: No ]
Incidence of adverse events and serious adverse events
Same as current
Complete list of historical versions of study NCT01318993 on ClinicalTrials.gov Archive Site
  • Change from baseline in vital signs, haematology and clinical chemistry parameters, electrocardiogram measurements [ Time Frame: Over 112 weeks ] [ Designated as safety issue: No ]
    Change from baseline in vital signs, haematology and clinical chemistry, electrocardiogram measurements
  • Change from baseline in CDAI score [ Time Frame: Over 112 weeks ] [ Designated as safety issue: No ]
    Change from baseline in CDAI score
  • Proportion of subjects in clinicalremission [ Time Frame: Over 112 weeks ] [ Designated as safety issue: No ]
    Proportion of subjects in clinical remission (CDAI score less than 150) for all subjects, for subjects in remission at baseline and for subjects not in remission at baseline
  • Proportion of subjects achieving clinical response [ Time Frame: Over 112 weeks ] [ Designated as safety issue: No ]
    Proportion of subjects achieving response (CDAI decrease of at least 100 points from baseline of prior induction study) in the sub-population of non-responders at study entry
  • Change from baseline in health outcome measures (IBDQ, SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's disease and disability) [ Time Frame: Over 112 weeks ] [ Designated as safety issue: No ]
    Change from baseline in IBDQ, SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and disability
Same as current
Not Provided
Not Provided
 
Open-Label Extension Study of GSK1605786A
An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects With Crohn's Disease

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.

This is a multi-centre, open-label extension study to assess the long-term safety, tolerability and effectiveness of GSK1605786A in subjects with Crohn's disease. Subjects will enter the study via one of three routes:

  1. completion of the placebo-controlled induction study, CCX114151, without achieving clinical response (CDAI decrease of at least 100 points) or clinical remission (CDAI score less than 150) at Week 12 or completion of any other GSK-sponsored induction study as designated by the sponsor
  2. completion of maintenance study CCX114157 at Week 52
  3. withdrawal from maintenance study CCX114157 due to worsening of Crohn's disease and requiring a treatment change.

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 disability.

It is estimated that approximately 800 subjects will be enrolled in total. All subjects will enter the study at baseline (Week 0) and commence oral treatment with GSK1605786A 500 mg twice daily.

The study will be conducted for 108 weeks. Once the results of the induction study CCX114151 are known, the risk-to-benefit ratio will be re-assessed and the study duration may be amended.

Study assessments for Crohn's disease will be performed every 12 weeks through Week 108. At week 12, the investigator will make a determination of whether the subject is receiving clinical benefit, and subjects who are not receiving clinical benefit must be withdrawn. More frequent blood draws are required for liver function testing only; every 2 weeks for the first 12 weeks, then every 4 weeks up to Week 52, and every 12 weeks after Week 60 for the duration of the study.

Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn's Disease
Drug: GSK1605786A
500 milligrams twice daily
Experimental: GSK1605786A
500 milligrams twice daily
Intervention: 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
400
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Chile,   Czech Republic,   Denmark,   Estonia,   France,   Germany,   Hong Kong,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   New Zealand,   Poland,   Portugal,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United Kingdom
 
NCT01318993
114644, 2010-022384-35
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