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GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease (SHIELD-2)

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:
ClinicalTrials.gov Identifier:
NCT01316939
First Posted: March 16, 2011
Last Update Posted: September 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention Phase
Crohn's Disease Drug: GSK1605786A Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 [ Time Frame: Week 28 and 52 ]
    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.


Secondary Outcome Measures:
  • 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 [ Time Frame: Week 28 and 52 ]
    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.

  • 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 [ Time Frame: Week 28 and 52 ]
    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.

  • 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 [ Time Frame: Upto Week 52 ]
    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.

  • Percentage of Participants in Clinical Remission at Week 52 [ Time Frame: 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.

  • Percentage of Participants With a Clinical Response (CDAI Decrease >=100 Points) at Both Weeks 28 and 52 of the 52-week Treatment Period [ Time Frame: Week 28 and 52 ]
    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.

  • Time to Induction of Clinical Remission in Participants Who Had Achieved Clinical Response During Induction Therapy But Were Not in Clinical Remission at Baseline [ Time Frame: Upto Week 52 ]
    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.

  • Change From Baseline in CDAI Score at Weeks 4, 8, 12, 20, 28, 36, 44, and 52 [ Time Frame: Baseline (Week 0) and 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.

  • Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52 [ Time Frame: Baseline (Week 0) and 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.

  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Upto 56 weeks ]
    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.

  • Change From Baseline in Vital Sign Systolic Blood Pressure Systolic (SBP) and Diastolic Blood Pressure (DBP) Upto Week 56 [ Time Frame: Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52, 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.

  • Change From Baseline in Vital Sign Heart Rate Upto Week 56 [ Time Frame: Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 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.

  • Number of Participants With Shift From Baseline in Hematology Parameters [ Time Frame: Upto Week 56 ]
    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.

  • Number of Participants With Shift From Baseline in Clinical Chemistry Parameters [ Time Frame: Upto Week 56 ]
    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.

  • 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. [ Time Frame: Baseline (Week 0) and 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.

  • 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 [ Time Frame: Baseline (Week 0) and 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.

  • 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 [ Time Frame: Baseline (Week 0) and 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.

  • Number of Participants With 12 Lead Electocardiogram (ECG) Abnormalities at Week 28 and 52 [ Time Frame: 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.

  • Change From Baseline in Short Form - 36 Version 2 (SF-36 v2) at Weeks 28 and 52 [ Time Frame: Baseline (Week 0) and 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.

  • Change From Baseline in European Quality of Life (EuroQol ) Five Dimensions Questionnaire (EQ-5D) at Weeks 28 and 52 [ Time Frame: Baseline (Week 0) and 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.

  • Change From Baseline in Work Productivity & Activity Impairment - Crohn's Disease (WPAI-CD) at Weeks 28 and 52 [ Time Frame: Baseline (Week 0) and 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.

  • Receipt of Disability Benefits at Weeks 28 and 52 [ Time Frame: 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.

  • Change From Baseline in Health-related Resource Utilization at Weeks 28 and 52 [ Time Frame: Baseline (Week 0) and 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.

  • Change From Baseline in C Reactive Protein (CRP) at Weeks 28 and 52 [ Time Frame: Baseline (Week 0 and 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.

  • Change From Baseline in Faecal Calprotectin at Weeks 28 and 52 [ Time Frame: Baseline (Week 0) and 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.


Enrollment: 229
Actual Study Start Date: May 9, 2011
Study Completion Date: October 23, 2013
Primary Completion Date: October 23, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Experimental: GSK1605786A once daily
500 milligrams once daily
Drug: GSK1605786A
GSK1605786A 500 milligrams once daily
Experimental: GSK1605786A twice daily
500 milligrams twice daily
Drug: GSK1605786A
GSK1605786A 500 milligrams twice daily

Detailed Description:
This is a multi-centre, randomised, placebo-controlled, double-blind parallel group study in adult subjects with Crohn's disease who previously achieved clinical response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior Phase III induction study (Study CCX114151 or another GSK sponsored induction study). Subjects will be randomised to 52 weeks of oral treatment with GSK1605786A 500 mg once daily or 500 mg twice daily or placebo. Subjects who are receiving concomitant corticosteroids at entry will undergo dose tapering following a defined schedule. Subjects who complete the treatment period may be eligible to enter an open-label extension study. Subjects who experience disease worsening and require additional (rescue) treatment will be withdrawn and may be eligible to enter the open-label study. Subjects who do not enter the open-label study must complete a follow-up assessment 4 weeks after completion of treatment. Approximately 756 subjects will be enrolled.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01316939


  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Little Rock, Arizona, United States, 72205
GSK Investigational Site
Tucson, Arizona, United States, 85712
United States, California
GSK Investigational Site
La Jolla, California, United States, 92093
GSK Investigational Site
San Diego, California, United States, 92103
GSK Investigational Site
San Francisco, California, United States, 94115
United States, Colorado
GSK Investigational Site
Aurora, Colorado, United States, 80045
GSK Investigational Site
Lakewood, Colorado, United States, 80215
GSK Investigational Site
Littleton, Colorado, United States, 80120
United States, Connecticut
GSK Investigational Site
Hamden, Connecticut, United States, 06518
GSK Investigational Site
New Haven, Connecticut, United States, 06510
United States, District of Columbia
GSK Investigational Site
Washington, D.C., District of Columbia, United States, 20007
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32256-6004
GSK Investigational Site
Port Orange, Florida, United States, 32127
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342-5006
GSK Investigational Site
Suwanee, Georgia, United States, 30024
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60637
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46237
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40536-0298
United States, Louisiana
GSK Investigational Site
Hammond, Louisiana, United States, 70403
GSK Investigational Site
Monroe, Louisiana, United States, 71201
United States, Maryland
GSK Investigational Site
Chevy Chase, Maryland, United States, 20815
GSK Investigational Site
Towson, Maryland, United States, 21204
GSK Investigational Site
Towson, Maryland, United States, 21286
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02114
United States, Michigan
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109-5682
GSK Investigational Site
Chesterfield, Michigan, United States, 48047
GSK Investigational Site
Troy, Michigan, United States, 48098
United States, Minnesota
GSK Investigational Site
Rochester, Minnesota, United States, 55905
United States, Missouri
GSK Investigational Site
Lee's Summit, Missouri, United States, 64064
GSK Investigational Site
Mexico, Missouri, United States, 65265-3726
United States, New York
GSK Investigational Site
Brooklyn, New York, United States, 11206
GSK Investigational Site
East Setauket, New York, United States, 11733-9292
GSK Investigational Site
Great Neck, New York, United States, 11021
GSK Investigational Site
Lake Success, New York, United States, 11042
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599-7080
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
GSK Investigational Site
Durham, North Carolina, United States, 27710
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
GSK Investigational Site
Columbus, Ohio, United States, 43215
United States, Oklahoma
GSK Investigational Site
Tulsa, Oklahoma, United States, 74135
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97225
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
GSK Investigational Site
Germantown, Tennessee, United States, 38138
GSK Investigational Site
Nashville, Tennessee, United States, 37212-1610
United States, Utah
GSK Investigational Site
Ogden, Utah, United States, 84405
United States, Virginia
GSK Investigational Site
Christiansburg, Virginia, United States, 24073
GSK Investigational Site
Danville, Virginia, United States, 24541
GSK Investigational Site
Norfolk, Virginia, United States, 23502
GSK Investigational Site
Richmond, Virginia, United States, 23249
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98101
GSK Investigational Site
Seattle, Washington, United States, 98195
United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53792
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
GSK Investigational Site
Bankstown, New South Wales, Australia, 2200
Australia, Queensland
GSK Investigational Site
Hersten, Queensland, Australia, 4029
Australia, South Australia
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
GSK Investigational Site
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
GSK Investigational Site
Box Hill, Victoria, Australia, 3128
GSK Investigational Site
Fitzroy, Victoria, Australia, 3065
GSK Investigational Site
Prahran, Victoria, Australia, 3181
Australia, Western Australia
GSK Investigational Site
Fremantle, Western Australia, Australia, 6160
Austria
GSK Investigational Site
Hall in Tirol, Austria, 6060
GSK Investigational Site
Linz, Austria, A-4021
GSK Investigational Site
Oberpullendorf, Austria, 7350
GSK Investigational Site
St.Veit/Glan, Austria, 9300
GSK Investigational Site
Wien, Austria, 1030
GSK Investigational Site
Wien, Austria, 1050
GSK Investigational Site
Wien, Austria, 1090
Belgium
GSK Investigational Site
Bonheiden, Belgium, 2820
GSK Investigational Site
Brussels, Belgium, 1000
GSK Investigational Site
Brussels, Belgium, 1200
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Kortrijk, Belgium, 8500
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Roeselare, Belgium, 8800
Bulgaria
GSK Investigational Site
Plovdiv, Bulgaria, 4002
GSK Investigational Site
Sofia, Bulgaria, 1407
GSK Investigational Site
Sofia, Bulgaria, 1431
GSK Investigational Site
Sofia, Bulgaria, 1527
GSK Investigational Site
Varna, Bulgaria, 9010
Canada, Alberta
GSK Investigational Site
Calgary, Alberta, Canada, T2N 4Z6
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 2X8
Canada, British Columbia
GSK Investigational Site
Abbotsford, British Columbia, Canada, V2S 3N5
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
GSK Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5
GSK Investigational Site
Hamilton, Ontario, Canada, L8N 4A6
GSK Investigational Site
Kingston, Ontario, Canada, K7L 5G2
GSK Investigational Site
London, Ontario, Canada, N6A 5A5
GSK Investigational Site
London, Ontario, Canada, N6A 5W9
GSK Investigational Site
Ottawa, Ontario, Canada, K1H 1A2
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H3A 1A1
GSK Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Canada
GSK Investigational Site
Quebec, Canada, G1S 4L8
GSK Investigational Site
Quebec, Canada, G3K 2P8
Chile
GSK Investigational Site
Vina del Mar, Chile, 2520012
Czechia
GSK Investigational Site
Hradec Králové, Czechia, 500 12
GSK Investigational Site
Olomouc, Czechia, 77520
GSK Investigational Site
Ostrava - Vitkovice, Czechia, 70384
GSK Investigational Site
Praha 10, Czechia, 100 34
GSK Investigational Site
Praha 4, Czechia, 140 21
GSK Investigational Site
Praha 7, Czechia, 17004
GSK Investigational Site
Praha 9, Czechia, 190 61
Denmark
GSK Investigational Site
Aalborg, Denmark, 9000
GSK Investigational Site
Aarhus, Denmark, 8000
GSK Investigational Site
Herlev, Denmark, 2730
GSK Investigational Site
Hvidovre, Denmark, 2605
GSK Investigational Site
Odense, Denmark, 5000
Estonia
GSK Investigational Site
Tallinn, Estonia, 10617
GSK Investigational Site
Tallinn, Estonia, EE-10138
GSK Investigational Site
Tartu, Estonia, 51014
France
GSK Investigational Site
Clichy cedex, France, 92118
GSK Investigational Site
Lille cedex, France, 59037
GSK Investigational Site
Nantes cedex 1, France, 44093
GSK Investigational Site
Nice cedex 3, France, 06202
GSK Investigational Site
Paris cedex 10, France, 75475
GSK Investigational Site
Pessac cedex, France, 33604
GSK Investigational Site
Saint-Priest en Jarez, France, 42270
GSK Investigational Site
Vandoeuvre Les Nancy, France, 54511
Germany
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89081
GSK Investigational Site
Frankfurt am Main, Hessen, Germany, 60590
GSK Investigational Site
Brinkum/Stuhr, Niedersachsen, Germany, 28816
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Minden, Nordrhein-Westfalen, Germany, 32423
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Berlin, Germany, 13353
GSK Investigational Site
Hamburg, Germany, 20148
GSK Investigational Site
Hamburg, Germany, 22559
Hong Kong
GSK Investigational Site
Hong Kong, Hong Kong
GSK Investigational Site
Shatin, New Territories, Hong Kong
Hungary
GSK Investigational Site
Bekescsaba, Hungary, 5600
GSK Investigational Site
Budapest, Hungary, 1062
GSK Investigational Site
Budapest, Hungary, 1083
GSK Investigational Site
Budapest, Hungary, 1136
GSK Investigational Site
Debrecen, Hungary, 4025
GSK Investigational Site
Mosonmagyaróvár, Hungary, 9200
GSK Investigational Site
Szekszárd, Hungary, 7100
GSK Investigational Site
Vác, Hungary, 2600
Israel
GSK Investigational Site
Afula, Israel, 18101
GSK Investigational Site
Beer Sheva, Israel, 84101
GSK Investigational Site
Haifa, Israel, 31096
GSK Investigational Site
Holon, Israel, 58100
GSK Investigational Site
Jerusalem, Israel, 91031
GSK Investigational Site
Jerusalem, Israel, 91120
GSK Investigational Site
Kfar Saba, Israel, 44281
GSK Investigational Site
Petah Tikva, Israel, 49100
GSK Investigational Site
Ramat-Gan, Israel, 52621
GSK Investigational Site
Tel Aviv, Israel, 64239
GSK Investigational Site
Zerifin, Israel, 70300
Italy
GSK Investigational Site
Palermo, Sicilia, Italy, 90127
GSK Investigational Site
Genova, Italy, 16132
GSK Investigational Site
Modena, Italy, 41100
GSK Investigational Site
Roma, Italy, 00152
GSK Investigational Site
Roma, Italy, 00168
Japan
GSK Investigational Site
Aichi, Japan, 460-0012
GSK Investigational Site
Chiba, Japan, 285-8741
GSK Investigational Site
Fukuoka, Japan, 812-8582
GSK Investigational Site
Fukuoka, Japan, 818-8502
GSK Investigational Site
Hiroshima, Japan, 720-8520
GSK Investigational Site
Hokkaido, Japan, 060-0033
GSK Investigational Site
Hyogo, Japan, 663-8501
GSK Investigational Site
Kagoshima, Japan, 892-0846
GSK Investigational Site
Kagoshima, Japan, 892-8512
GSK Investigational Site
Miyagi, Japan, 981-3213
GSK Investigational Site
Osaka, Japan, 530-0011
GSK Investigational Site
Osaka, Japan, 545-8586
GSK Investigational Site
Tokyo, Japan, 160-8582
GSK Investigational Site
Tokyo, Japan, 169-0073
Korea, Republic of
GSK Investigational Site
Daegu, Korea, Republic of, 705-717
GSK Investigational Site
Pusan, Korea, Republic of, 602-739
GSK Investigational Site
Seoul, Korea, Republic of, 120-752
GSK Investigational Site
Seoul, Korea, Republic of, 130702
GSK Investigational Site
Seoul, Korea, Republic of, 135710
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
GSK Investigational Site
Wonju, Korea, Republic of, 220701
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1081 HV
GSK Investigational Site
Amsterdam, Netherlands, 1091 AC
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ
GSK Investigational Site
EDE, Netherlands, 6716 RP
GSK Investigational Site
Eindhoven, Netherlands, 5623 EJ
GSK Investigational Site
Rotterdam, Netherlands, 3015 CE
GSK Investigational Site
Rotterdam, Netherlands, 3083 AN
New Zealand
GSK Investigational Site
Dunedin, New Zealand, 9054
GSK Investigational Site
Lower Hutt, New Zealand, 6007
GSK Investigational Site
Otahuhu, Auckland, New Zealand, 2025
GSK Investigational Site
Tauranga., New Zealand, 3143
Norway
GSK Investigational Site
Tromsø, Norway, 9038
GSK Investigational Site
Tønsberg, Norway, 3116
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-168
GSK Investigational Site
Bydgoszcz, Poland, 85-681
GSK Investigational Site
Lublin, Poland, 20-582
GSK Investigational Site
Sopot, Poland, 81-756
GSK Investigational Site
Torun, Poland, 87-100
GSK Investigational Site
Wroclaw, Poland, 53-333
Portugal
GSK Investigational Site
Lisboa, Portugal, 1649-035
GSK Investigational Site
Lisboa, Portugal, 1769-001
GSK Investigational Site
Porto, Portugal, 4099-001
GSK Investigational Site
Viseu, Portugal, 3504-509
Russian Federation
GSK Investigational Site
Irkutsk, Russian Federation, 664079
GSK Investigational Site
Kazan, Russian Federation, 420064
GSK Investigational Site
Lipetsk, Russian Federation, 398055
GSK Investigational Site
Moscow, Russian Federation, 129110
GSK Investigational Site
Nizhniy Novgorod, Russian Federation, 603126
GSK Investigational Site
Rostov-on-Don, Russian Federation, 344091
GSK Investigational Site
Samara, Russian Federation, 443011
GSK Investigational Site
St. Petersburg, Russian Federation, 196247
GSK Investigational Site
St. Petersburg, Russian Federation, 197047
GSK Investigational Site
Tomsk, Russian Federation, 634063
Slovakia
GSK Investigational Site
Bratislava, Slovakia, 831 04
GSK Investigational Site
Bratislava, Slovakia, 851 01
GSK Investigational Site
Bratislava, Slovakia, 851 07
GSK Investigational Site
Nitra, Slovakia, 949 01
GSK Investigational Site
Nove Mesto nad Vahom, Slovakia, 915 01
GSK Investigational Site
Presov, Slovakia, 080 01
GSK Investigational Site
Trnava, Slovakia, 917 02
South Africa
GSK Investigational Site
Bellville, South Africa, 7530
GSK Investigational Site
Claremont, South Africa, 7708
GSK Investigational Site
Observatory, South Africa, 7925
GSK Investigational Site
Parktown, South Africa, 2192
Spain
GSK Investigational Site
Badalona, Spain, 08916
GSK Investigational Site
Elche, Spain, 03293
GSK Investigational Site
Fuenlabrada (Madrid), Spain, 28942
GSK Investigational Site
Galdakao/Vizcaya, Spain, 48960
GSK Investigational Site
Madrid, Spain, 28006
GSK Investigational Site
Madrid, Spain, 28007
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Marbella, Spain, 29600
GSK Investigational Site
Sabadell (Barcelona), Spain, 08208
GSK Investigational Site
Santander (Cantabria), Spain, 39008
Sweden
GSK Investigational Site
Lund, Sweden, SE-221 85
GSK Investigational Site
Stockholm, Sweden, SE-171 76
GSK Investigational Site
Stockholm, Sweden, SE-182 88
Switzerland
GSK Investigational Site
Bern, Switzerland, 3004
GSK Investigational Site
Zürich, Switzerland, 8091
Taiwan
GSK Investigational Site
Taichung, Taiwan, 40705
Turkey
GSK Investigational Site
Ankara, Turkey, 06100
Ukraine
GSK Investigational Site
Chernivtsi, Ukraine, 58005
GSK Investigational Site
Dnipropetrovsk, Ukraine, 49044
GSK Investigational Site
Donetsk, Ukraine, 83003
GSK Investigational Site
Donetsk, Ukraine, 83017
GSK Investigational Site
Kharkiv, Ukraine, 61037
GSK Investigational Site
Kyiv, Ukraine
GSK Investigational Site
Odesa, Ukraine, 65117
GSK Investigational Site
Simferopol, Ukraine, 95017
GSK Investigational Site
Vinnytsya, Ukraine, 21029
United Kingdom
GSK Investigational Site
Harrow, Middlesex, United Kingdom, HA1 3UJ
GSK Investigational Site
Birmingham, United Kingdom, B9 5SS
GSK Investigational Site
Bristol, United Kingdom, BS2 8HW
GSK Investigational Site
Edinburgh, United Kingdom, EH4 2XU
GSK Investigational Site
Manchester, United Kingdom, M13 9WL
GSK Investigational Site
Newcastle-upon-Tyne, United Kingdom, NE1 4LP
GSK Investigational Site
Oxford, United Kingdom, OX3 9DU
GSK Investigational Site
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01316939     History of Changes
Other Study ID Numbers: 114157
2010-022383-12 ( EudraCT Number )
First Submitted: March 3, 2011
First Posted: March 16, 2011
Results First Submitted: June 28, 2017
Results First Posted: September 7, 2017
Last Update Posted: September 7, 2017
Last Verified: August 2017

Keywords provided by GlaxoSmithKline:
Crohn's disease, oral CCR9 antagonist, placebo-controlled, maintenance of remission, 52-week treatment, quality of life

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases