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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01316939




Registration number
NCT01316939
Ethics application status
Date submitted
3/03/2011
Date registered
16/03/2011
Date last updated
7/09/2017

Titles & IDs
Public title
GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease
Scientific 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
Secondary ID [1] 0 0
2010-022383-12
Secondary ID [2] 0 0
114157
Universal Trial Number (UTN)
Trial acronym
SHIELD-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK1605786A
Treatment: Drugs - Placebo
Treatment: Drugs - GSK1605786A

Placebo comparator: Placebo - Placebo

Experimental: GSK1605786A once daily - 500 milligrams once daily

Experimental: GSK1605786A twice daily - 500 milligrams twice daily


Treatment: Drugs: GSK1605786A
GSK1605786A 500 milligrams once daily

Treatment: Drugs: Placebo
Placebo

Treatment: Drugs: GSK1605786A
GSK1605786A 500 milligrams twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 28 and 52
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 28 and 52
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Week 28 and 52
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Upto Week 52
Secondary outcome [4] 0 0
Percentage of Participants in Clinical Remission at Week 52
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Percentage of Participants With a Clinical Response (CDAI Decrease >=100 Points) at Both Weeks 28 and 52 of the 52-week Treatment Period
Timepoint [5] 0 0
Week 28 and 52
Secondary outcome [6] 0 0
Time to Induction of Clinical Remission in Participants Who Had Achieved Clinical Response During Induction Therapy But Were Not in Clinical Remission at Baseline
Timepoint [6] 0 0
Upto Week 52
Secondary outcome [7] 0 0
Change From Baseline in CDAI Score at Weeks 4, 8, 12, 20, 28, 36, 44, and 52
Timepoint [7] 0 0
Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, and 52
Secondary outcome [8] 0 0
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52
Timepoint [8] 0 0
Baseline (Week 0) and Week 52
Secondary outcome [9] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [9] 0 0
Upto 56 weeks
Secondary outcome [10] 0 0
Change From Baseline in Vital Sign Systolic Blood Pressure Systolic (SBP) and Diastolic Blood Pressure (DBP) Upto Week 56
Timepoint [10] 0 0
Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52, 56
Secondary outcome [11] 0 0
Change From Baseline in Vital Sign Heart Rate Upto Week 56
Timepoint [11] 0 0
Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56
Secondary outcome [12] 0 0
Number of Participants With Shift From Baseline in Hematology Parameters
Timepoint [12] 0 0
Upto Week 56
Secondary outcome [13] 0 0
Number of Participants With Shift From Baseline in Clinical Chemistry Parameters
Timepoint [13] 0 0
Upto Week 56
Secondary outcome [14] 0 0
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.
Timepoint [14] 0 0
Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56.
Secondary outcome [15] 0 0
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
Timepoint [15] 0 0
Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56
Secondary outcome [16] 0 0
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
Timepoint [16] 0 0
Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56
Secondary outcome [17] 0 0
Number of Participants With 12 Lead Electocardiogram (ECG) Abnormalities at Week 28 and 52
Timepoint [17] 0 0
Week 28 and 52
Secondary outcome [18] 0 0
Change From Baseline in Short Form - 36 Version 2 (SF-36 v2) at Weeks 28 and 52
Timepoint [18] 0 0
Baseline (Week 0) and Weeks 28 and 52
Secondary outcome [19] 0 0
Change From Baseline in European Quality of Life (EuroQol ) Five Dimensions Questionnaire (EQ-5D) at Weeks 28 and 52
Timepoint [19] 0 0
Baseline (Week 0) and Weeks 28 and 52
Secondary outcome [20] 0 0
Change From Baseline in Work Productivity & Activity Impairment - Crohn's Disease (WPAI-CD) at Weeks 28 and 52
Timepoint [20] 0 0
Baseline (Week 0) and Weeks 28 and 52
Secondary outcome [21] 0 0
Receipt of Disability Benefits at Weeks 28 and 52
Timepoint [21] 0 0
Weeks 28 and 52
Secondary outcome [22] 0 0
Change From Baseline in Health-related Resource Utilization at Weeks 28 and 52
Timepoint [22] 0 0
Baseline (Week 0) and Weeks 28 and 52
Secondary outcome [23] 0 0
Change From Baseline in C Reactive Protein (CRP) at Weeks 28 and 52
Timepoint [23] 0 0
Baseline (Week 0 and Weeks 28 and 52
Secondary outcome [24] 0 0
Change From Baseline in Faecal Calprotectin at Weeks 28 and 52
Timepoint [24] 0 0
Baseline (Week 0) and Weeks 28 and 52

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/10/2013
Sample size
Target
Accrual to date
Final
229
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Bankstown
Recruitment hospital [2] 0 0
GSK Investigational Site - Hersten
Recruitment hospital [3] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [4] 0 0
GSK Investigational Site - Kurralta Park
Recruitment hospital [5] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [6] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [7] 0 0
GSK Investigational Site - Prahran
Recruitment hospital [8] 0 0
GSK Investigational Site - Fremantle
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
4029 - Hersten
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3181 - Prahran
Recruitment postcode(s) [8] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
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Oxford
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
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Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01316939
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01316939