Last updated: 11/07/2018 07:19:54

GSK1605786A in the Maintenance of Remission in Subjects with Crohn's DiseaseSHIELD-2

GSK study ID

114157

See study documents

Clinicaltrials.gov ID

NCT01316939

See results summary

EudraCT ID

2010-022383-12

EU CT Number

Not applicable

Trial status

Other

Overview

Eligibility

Locations

Study documents

Results summary

Plain language summaries

Additional information

Trial overview

Official title: 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

Trial description: 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.

Primary purpose:

Treatment

Trial design:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Allocation:

Randomized

Primary outcomes:

Percentage of participants in clinical remission (Crohn’s Disease Activity Index , CDAI score <150 points) at both Weeks 28 and 52 of the 52-week treatment period

Timeframe: Week 28 and 52

Secondary outcomes:

Percentage of participants in clinical remission (CDAI score <150 points) and not taking corticosteroids at both Weeks 28 and 52 of the 52-week treatment period

Timeframe: Week 28 and 52

Percentage of participants in clinical remission at both Weeks 28 and 52 of the 52-week treatment period among those participants who were in clinical remission at Baseline

Timeframe: Week 28 and 52

Percentage of participants in clinical remission at all visits (continuous clinical remission) during the 52-week treatment period among participants in clinical remission at Baseline

Timeframe: Upto Week 52

Percentage of participants in clinical remission at Week 52

Timeframe: Week 52

Percentage of participants with a clinical response (CDAI decrease >=100 points) at both Weeks 28 and 52 of the 52-week treatment period

Timeframe: Week 28 and 52

Time to induction of clinical remission in participants who had achieved clinical response during induction therapy but were not in clinical remission at Baseline

Timeframe: Upto Week 52

Change from Baseline in CDAI score at Weeks 4, 8, 12, 20, 28, 36, 44, and 52

Timeframe: Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, and 52

Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 52

Timeframe: Baseline (Week 0) and Week 52

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Timeframe: Upto 56 weeks

Change from Baseline in vital sign systolic blood pressure systolic (SBP) and diastolic blood pressure (DBP) upto Week 56

Timeframe: Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52, 56

Change from Baseline in vital sign heart rate upto Week 56

Timeframe: Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56

Number of participants with shift from Baseline in hematology parameters

Timeframe: Upto Week 56

Number of participants with shift from Baseline in clinical chemistry parameters

Timeframe: Upto Week 56

Change from Baseline in liver function test parameter total bilirubin at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56.

Timeframe: Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56.

Change from Baseline in liver function test parameter albumin at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56

Timeframe: Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56

Change from Baseline in liver function test parameter alanine amino transferase, aspartate amino transferase, alkaline phosphatase and gamma glutamyl transferase at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56

Timeframe: Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56