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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Clinical remission is defined as a CDAI score <150 points. In the missing=no effect imputation, participants with missing CDAI scores was considered not to be in clinical remission. Data for percentage of participants in at both Weeks 28 and 52 of the 52-week treatment period have been presented.
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 - Clinical remission is defined as a CDAI score <150 points. A participant was considered to be not taking corticosteroids at Weeks 28 and 52 if the participant had not taken a corticosteroid for the 8 days prior to and the day of the CDAI assessment for each of Weeks 28 and 52. In the missing=no effect imputation, participants with missing CDAI scores was considered not to be in clinical remission. Data for percentage of participants in clinical remission and not taking corticosteroids at both Weeks 28 and 52 of the 52-week treatment period have been presented.
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 - Clinical remission is defined as a CDAI score <150 points. Among participants in remission at baseline, the percentage of participants with clinical remission at both Weeks 28 and 52 of the treatment period using the no effect imputation for missing data were to be compared between each GSK1605786A dose group and placebo using Fisher's exact test. Participants with missing CDAI scores were to be considered not to be in remission according to the missing=no effect imputation. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease.
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 - The percentage of participants with clinical remission at all visits during the 52-week treatment period were to be summarized by treatment group for the subset of participants in remission at baseline, using the no effect imputation for missing data. Participants with missing CDAI scores were to be considered not to be in remission according to the missing=no effect imputation. Comparisons between each GSK1605786A dose group and placebo were to be made using Fisher's exact test.The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease.
Timepoint [3] 0 0
Upto Week 52
Secondary outcome [4] 0 0
Percentage of Participants in Clinical Remission at Week 52 - The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease.
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 - Clinical response is defined as a reduction from the induction study baseline CDAI score of >=100 points. The percentage of participants with a clinical response at both Weeks 28 and 52 of the 52-week maintenance treatment period in the ITT population using the no effect imputation for missing data were to be compared between each GSK1605786A dose group and placebo using Fisher's exact test. Participants with missing CDAI scores were to be considered non-responders according to the missing=no effect imputation. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease.
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 - The duration of time participants maintained clinical remission during the 52-week treatment period was to be defined as the time between Week 0 and the first visit where remission was not observed in those participants in remission at baseline. These time periods were to be summarized by treatment group using quartiles and their corresponding confidence intervals. Comparisons between each GSK1605786A dose group and placebo were to be made using log-rank tests. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease.
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 - The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. 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. CDAI scores and changes in CDAI scores during the 52-week treatment period were to be summarized by treatment group at Weeks 4, 8, 12, 20, 28, 36, 44, and 52. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.
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 - The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The IBDQ questionnaire was to be completed by each participant at baseline and at Weeks 28, and 52. The response to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better quality of life. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.
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) - 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 AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.
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 - Vital sign assessments included SBP and DBP collected in supine position following 5 minutes of rest. Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44, 52 and Week 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.
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 - Vital sign assessment included heart rate collected in supine position following 5 minutes of rest. Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.
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 - Hematology parameters included platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils, hematocrit, red blood cell count, hemoglobin, white blood cell count and segmented neutrophils . Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44 and 52 and 56. The consolidated data for number of participants with shift from Baseline (change from Baseline) in hematology parameters characterized as high and low have been presented.
Timepoint [12] 0 0
Upto Week 56
Secondary outcome [13] 0 0
Number of Participants With Shift From Baseline in Clinical Chemistry Parameters - Clinical chemistry parameters included total protein, phosphorous, albumin, sodium, potassium, chloride, calcium, glucose, gamma glutamyl transferase, total bilirubin, direct bilirubin, alkaline phosphatase, alanine amino transferase, aspartate amino transferase, blood urea nitrogen (BUN)/Urea, creatinine, uric acid, lactate dehydrogenase, bicarbonate, cholesterol and creatinine kinase. Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56. The consolidated data for number of participants with shift from Baseline (change from Baseline) in clinical chemistry parameters characterized as high and low have been presented.
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. - Liver function test parameter included total bilirubin. Assessments were carried out at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.
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 - Liver function test parameter included albumin. Assessments were carried out at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56.Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.
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 - Liver function test parameters included alanine amino transferase, aspartate amino transferase, alkaline phosphatase and gamma glutamyl transferase. Assessments were carried out at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.
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 - A 12 lead ECG was collected at Weeks 28 and 52. ECG abnormalities were characterized as abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS). A-NCS data for Week 28 and 52 have been presented.
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 - The SF-36v2 health survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health). SF-36 v2 items are scored such that a higher score indicates a better health state and better functioning. Data for change from Baseline in SF-36 v2 at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.
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 - EQ-5D self-reported questionnaire is used to measure health-related quality of life by measuring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D questionnaire includes a visual analog scale (VAS) which records participants self-rated health status on a graduated (0-100) scale with higher scores indicating higher Health-Related Quality of Life (HRQoL). Data for Change from Baseline in EuroQol five dimensions questionnaire (EQ-5D) at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.
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 - WPAI measures the effect of your CD on your ability to work and perform regular activities. 6-items assess impairment in work productivity and daily activity during the 7 days before the assessment. It measures the percentage of overall impairment in work productivity and daily activity due to CD. A WPAI score of 0% = no impairment and a score of 100% = total loss of work productivity or activity. An absolute change in WPAI score of 7% is considered the minimum clinically important difference (MCID). Data for change from Baseline in WPAI-CD at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.
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 - Receipt of disability benefits (Yes/No) was to be recorded at Weeks 0, 28 and 52 and Early Withdrawal visit if applicable. Change from baseline in receipt of disability benefits was to be compared between participants in remission versus participants not in remission using a Wilcoxon rank sum test. Data for Receipt of disability benefits at Weeks 28 and 52 was not collected following early termination of this study.
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 - Healthcare related resource utilization was to include: Hospitalizations (all cause and Crohn's disease related), Length of stay, Surgical procedures (all cause and Crohn's disease related), Outpatient visits (all cause and Crohn's disease related ). The frequency of hospitalizations, surgical procedures and hospital out-patient visits were to be recorded at Weeks 28 and 52. The number and percentage of participants reporting all cause and Crohn's disease -related hospitalizations, surgeries, and hospital out-patient visits were to be summarized and compared between each GSK1605786A dose group and placebo using Fisher's exact test. Data for Change from Baseline in health-related resource utilization at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.
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 - C-reactive protein (CRP) at was to be assessed at Weeks 4, 8, 12, 20, 28, 36, 44, 52 visit if applicable. Data for Change from Baseline in C reactive protein (CRP) at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.
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 - Stool sample for faecal calprotectin were to be collected at Weeks 28 and 52 visit if applicable. Data for Change from baseline in faecal calprotectin at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.
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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Utah
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
United States of America
State/province [27] 0 0
Wisconsin
Country [28] 0 0
Austria
State/province [28] 0 0
Hall in Tirol
Country [29] 0 0
Austria
State/province [29] 0 0
Linz
Country [30] 0 0
Austria
State/province [30] 0 0
Oberpullendorf
Country [31] 0 0
Austria
State/province [31] 0 0
St.Veit/Glan
Country [32] 0 0
Austria
State/province [32] 0 0
Wien
Country [33] 0 0
Belgium
State/province [33] 0 0
Bonheiden
Country [34] 0 0
Belgium
State/province [34] 0 0
Brussels
Country [35] 0 0
Belgium
State/province [35] 0 0
Gent
Country [36] 0 0
Belgium
State/province [36] 0 0
Kortrijk
Country [37] 0 0
Belgium
State/province [37] 0 0
Leuven
Country [38] 0 0
Belgium
State/province [38] 0 0
Roeselare
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Plovdiv
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Sofia
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Varna
Country [42] 0 0
Canada
State/province [42] 0 0
Alberta
Country [43] 0 0
Canada
State/province [43] 0 0
British Columbia
Country [44] 0 0
Canada
State/province [44] 0 0
Manitoba
Country [45] 0 0
Canada
State/province [45] 0 0
Nova Scotia
Country [46] 0 0
Canada
State/province [46] 0 0
Ontario
Country [47] 0 0
Canada
State/province [47] 0 0
Quebec
Country [48] 0 0
Chile
State/province [48] 0 0
Vina del Mar
Country [49] 0 0
Czechia
State/province [49] 0 0
Hradec Králové
Country [50] 0 0
Czechia
State/province [50] 0 0
Olomouc
Country [51] 0 0
Czechia
State/province [51] 0 0
Ostrava - Vitkovice
Country [52] 0 0
Czechia
State/province [52] 0 0
Praha 10
Country [53] 0 0
Czechia
State/province [53] 0 0
Praha 4
Country [54] 0 0
Czechia
State/province [54] 0 0
Praha 7
Country [55] 0 0
Czechia
State/province [55] 0 0
Praha 9
Country [56] 0 0
Denmark
State/province [56] 0 0
Aalborg
Country [57] 0 0
Denmark
State/province [57] 0 0
Aarhus
Country [58] 0 0
Denmark
State/province [58] 0 0
Herlev
Country [59] 0 0
Denmark
State/province [59] 0 0
Hvidovre
Country [60] 0 0
Denmark
State/province [60] 0 0
Odense
Country [61] 0 0
Estonia
State/province [61] 0 0
Tallinn
Country [62] 0 0
Estonia
State/province [62] 0 0
Tartu
Country [63] 0 0
France
State/province [63] 0 0
Clichy cedex
Country [64] 0 0
France
State/province [64] 0 0
Lille cedex
Country [65] 0 0
France
State/province [65] 0 0
Nantes cedex 1
Country [66] 0 0
France
State/province [66] 0 0
Nice cedex 3
Country [67] 0 0
France
State/province [67] 0 0
Paris cedex 10
Country [68] 0 0
France
State/province [68] 0 0
Pessac cedex
Country [69] 0 0
France
State/province [69] 0 0
Saint-Priest en Jarez
Country [70] 0 0
France
State/province [70] 0 0
Vandoeuvre Les Nancy
Country [71] 0 0
Germany
State/province [71] 0 0
Baden-Wuerttemberg
Country [72] 0 0
Germany
State/province [72] 0 0
Hessen
Country [73] 0 0
Germany
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

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/show/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/show/NCT01316939