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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01318993
Registration number
NCT01318993
Ethics application status
Date submitted
3/03/2011
Date registered
21/03/2011
Date last updated
14/09/2017
Titles & IDs
Public title
Open-Label Extension Study of GSK1605786A
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Scientific title
An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects With Crohn's Disease
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Secondary ID [1]
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2010-022384-35
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Secondary ID [2]
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114644
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Universal Trial Number (UTN)
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Trial acronym
SHIELD-3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Inflammatory bowel disease
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Inflammatory and Immune System
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0
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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0
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GSK1605786A
Experimental: GSK1605786A - 500 milligrams twice daily
Treatment: Drugs: GSK1605786A
500 milligrams twice daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE)
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Assessment method [1]
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An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. The Safety population consisted of all participants who enrolled in the study except those who did not take >=1 dose of investigational product.
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Timepoint [1]
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Up to Week 112
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Secondary outcome [1]
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Change From Baseline (Week 0) in Systolic and Diastolic Blood Pressure (SBP and DBP) Over Period
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Assessment method [1]
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The SBP and DBP values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Baseline value was recorded at Week 0. Change from Baseline measurements in SBP and DBP were assessed at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
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Timepoint [1]
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Baseline (Week 0) and up to Week 112
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Secondary outcome [2]
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Change From Baseline (Week 0) in Heart Rate (HR) Over Period
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Assessment method [2]
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The HR values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Change from Baseline in HR was assessed at Week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
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Timepoint [2]
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Baseline (week 0) and up to Week 112
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Secondary outcome [3]
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Number of Participants With Shifts From Baseline (Week 0) for the Indicated Hematology Parameters
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Assessment method [3]
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Hematology parameters measured included platelets, neutrophils (NL), lymphocytes, monocytes, eosinophils, basophils, hematocrit, band cells, red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count, and segmented (seg) NL. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated hematology parameters data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, shift to high) until 4 weeks post treatment are presented.
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Timepoint [3]
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Baseline (Week 0) and up to Week 112
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Secondary outcome [4]
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Number of Participants With Shifts From Baseline (Week 0) for the Indicated Clinical Chemistry Parameters
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Assessment method [4]
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Clinical chemistry parameters included platelets, total protein, phosphorous, albumin, sodium, potassium, chloride, calcium, glucose, gamma-glutamyl transferase, total bilirubin (TB), direct bilirubin (DB), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN)/urea, creatinine, uric acid, bicarbonate, lactate dehydrogenase, cholesterol, alkaline phosphatase (ALP), gamma glutamyl transferases (GGT), and creatine kinase. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated clinical chemistry parameters' data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, or shift to high) until 4 weeks post-treatment are presented.
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Timepoint [4]
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Baseline (Week 0) and up to Week 112
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Secondary outcome [5]
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Change From Baseline (Week 0) in ALT, AST, ALP, and GGT as a Function of Liver Function Test (LFT)
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Assessment method [5]
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Changes in Baseline in ALP, ALT, AST, and GGT were assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.
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Timepoint [5]
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Baseline (Week 0) and up to Week 112
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Secondary outcome [6]
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Change From Baseline (Week 0) in Total Bilirubin
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Assessment method [6]
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Changes from Baseline (Week 0) in total bilirubin (TB) was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.
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Timepoint [6]
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Baseline (Week 0) and up to Week 112
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Secondary outcome [7]
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Change From Baseline (Week 0) in Albumin
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Assessment method [7]
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Change from Baseline in albumin was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post treatment. The last value on or prior to the treatment start date (Week 0) was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.
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Timepoint [7]
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Baseline (Week 0) and up to Week 112
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Secondary outcome [8]
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Number of Participants With the Indicated Change From Baseline (Week 0) in Corrected QT Interval (QTc) Value
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Assessment method [8]
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QTc is the corrected QT interval as measured by the electrocardiogram (ECG). ECG parameters including the change from Baseline in the QTc interval values QTcF and QTcB were summarised. The QTcF is Fridericia's formula and defined as the QT interval/cubed root of the R-R interval. The QTcB is the Bazett's formula defined as the QT/squared root of the R-R interval. The number of participants with change from Baseline in the QTcF and QTcB intervals of >30, 30 to <60 and >=60 milliseconds were assessed at Week 24, 48, 72, 108, and Week 112. The last value on or prior to the treatment start date was considered the Baseline value (Week 0). Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
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Timepoint [8]
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Baseline (week 0) and Weeks 24, 48, 72, 108, and 112 (4 weeks post treatment)
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Secondary outcome [9]
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Change From Baseline (Week 0) in Crohn's Disease Activity Index (CDAI) Score Over 108 Weeks
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Assessment method [9]
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The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant,investigator entries, standardized weight determination, and Hematocrit values received from the central laboratory. The Baseline CDAI score was recorded pre-dose on Week 0. Change from Baseline is the value at indicated time point minus the Baseline value. Remissions are defined as participants with CDAI score of < 150 points. No imputation for missing data was performed. The assessment was based on questionnaire like number of liquid stool in past 7 days, abdominal pain, other symptoms, antidiarrheal use, abdominal mass, anemia, and body weight. The total score is summation of all individual sub-scores. CDAI scoring scale ranges from 0-500 and a score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
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Timepoint [9]
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Baseline (Week 0) and up to 108 weeks
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Secondary outcome [10]
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Percentage of Participants in Clinical Remission (CDAI Score Less Than 150) for All Participants, for Participants in Remission at Baseline (Week 0), and for Participants Not in Remission at Baseline Over 108 Weeks
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Assessment method [10]
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The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product is taken. The CDAI score was measured over 108 weeks although it was planned to be measured till 112 weeks. Remissions are defined as subjects with CDAI score of < 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed. Combined data for participants with remission at Baseline and without remission at Baseline has been presented.
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Timepoint [10]
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Baseline (Week 0) and up to 108 weeks
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Secondary outcome [11]
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Percentage of Participants Achieving Response (CDAI Decrease of at Least 100 Points From Baseline ([Week 0] of Prior Induction Study) in the Sub-population of Non-responders at Study Entry Over 112 Weeks
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Assessment method [11]
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The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product was taken. Remissions are defined as subjects with CDAI score of < 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed.
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Timepoint [11]
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Baseline (Week 0) and up to 112 weeks
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Secondary outcome [12]
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Change From Baseline (Week 0) in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form Health Survey (SF-36) Version 2, EuroQol 5 Dimensional (EQ-5D), Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and Disability Over 112 Weeks
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Assessment method [12]
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IBDQ, SF-36, EQ-5D, WPAI-CD, and disability scores were all health outcome related scores that were based on assessment of participants based on different questionnaire. Each scoring scale had different range and participants were planned to be rated separately based on each scale.
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Timepoint [12]
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Baseline (Week 0) and up to 112 weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/10/2013
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Sample size
Target
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Accrual to date
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Final
399
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - Bankstown
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GSK Investigational Site - Hersten
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Recruitment hospital [3]
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GSK Investigational Site - Adelaide
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Recruitment hospital [4]
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GSK Investigational Site - Kurralta Park
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Recruitment hospital [5]
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GSK Investigational Site - Box Hill
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Recruitment hospital [6]
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GSK Investigational Site - Fitzroy
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Recruitment hospital [7]
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GSK Investigational Site - Prahran
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Recruitment hospital [8]
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GSK Investigational Site - Fremantle
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Recruitment postcode(s) [1]
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2200 - Bankstown
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Recruitment postcode(s) [2]
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4029 - Hersten
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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5037 - Kurralta Park
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Recruitment postcode(s) [5]
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3128 - Box Hill
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Recruitment postcode(s) [6]
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3065 - Fitzroy
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Recruitment postcode(s) [7]
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3181 - Prahran
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Recruitment postcode(s) [8]
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6160 - Fremantle
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Recruitment outside Australia
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Colorado
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Connecticut
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Illinois
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Linz
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Paris cedex 10
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France
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Saint-Priest en Jarez
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France
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Vandoeuvre Les Nancy
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Germany
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Baden-Wuerttemberg
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Germany
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Hessen
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Niedersachsen
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Berlin
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Salford
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Funding & Sponsors
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GlaxoSmithKline
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01318993
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Contacts
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GSK Clinical Trials
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GlaxoSmithKline
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01318993
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