Back to results

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

Primary Purpose

Crohn's Disease

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

GSK1605786A

Placebo

GSK1605786A

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, oral CCR9 antagonist, placebo-controlled, maintenance of remission, 52-week treatment, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

GSK1605786A once daily

GSK1605786A twice daily

Arm Description

Placebo

500 milligrams once daily

500 milligrams twice daily

Outcomes

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

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

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

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

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

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

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

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

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

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)

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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.

Full Information

NCT ID

NCT01316939

First Posted

March 3, 2011

Last Updated

August 7, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01316939

Brief Title

GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease

Acronym

SHIELD-2

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Terminated

Why Stopped

This study was terminated due to the lack of efficacy of GSK1605786A in Crohn's disease based on the results of Study CCX114151.

Study Start Date

May 9, 2011 (Actual)

Primary Completion Date

October 23, 2013 (Actual)

Study Completion Date

October 23, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

Keywords

Crohn's disease, oral CCR9 antagonist, placebo-controlled, maintenance of remission, 52-week treatment, quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

229 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

GSK1605786A once daily

Arm Type

Experimental

Arm Description

500 milligrams once daily

Arm Title

GSK1605786A twice daily

Arm Type

Experimental

Arm Description

500 milligrams twice daily

Intervention Type

Drug

Intervention Name(s)

GSK1605786A

Intervention Description

GSK1605786A 500 milligrams once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Intervention Type

Drug

Intervention Name(s)

GSK1605786A

Intervention Description

GSK1605786A 500 milligrams twice daily

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Week 28 and 52

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Week 28 and 52

Title

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

Description

Time Frame

Week 28 and 52

Title

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

Description

Time Frame

Upto Week 52

Title

Percentage of Participants in Clinical Remission at Week 52

Description

Time Frame

Week 52

Title

Percentage of Participants With a Clinical Response (CDAI Decrease >=100 Points) at Both Weeks 28 and 52 of the 52-week Treatment Period

Description

Time Frame

Week 28 and 52

Title

Time to Induction of Clinical Remission in Participants Who Had Achieved Clinical Response During Induction Therapy But Were Not in Clinical Remission at Baseline

Description

Time Frame

Upto Week 52

Title

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

Description

Time Frame

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

Title

Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52

Description

Time Frame

Baseline (Week 0) and Week 52

Title

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

Upto 56 weeks

Title

Change From Baseline in Vital Sign Systolic Blood Pressure Systolic (SBP) and Diastolic Blood Pressure (DBP) Upto Week 56

Description

Time Frame

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

Title

Change From Baseline in Vital Sign Heart Rate Upto Week 56

Description

Time Frame

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

Title

Number of Participants With Shift From Baseline in Hematology Parameters

Description

Time Frame

Upto Week 56

Title

Number of Participants With Shift From Baseline in Clinical Chemistry Parameters

Description

Time Frame

Upto Week 56

Title

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.

Description

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.

Title

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

Description

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

Title

Description

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

Title

Number of Participants With 12 Lead Electocardiogram (ECG) Abnormalities at Week 28 and 52

Description

Time Frame

Week 28 and 52

Title

Change From Baseline in Short Form - 36 Version 2 (SF-36 v2) at Weeks 28 and 52

Description

Time Frame

Baseline (Week 0) and Weeks 28 and 52

Title

Change From Baseline in European Quality of Life (EuroQol ) Five Dimensions Questionnaire (EQ-5D) at Weeks 28 and 52

Description

Time Frame

Baseline (Week 0) and Weeks 28 and 52

Title

Change From Baseline in Work Productivity & Activity Impairment - Crohn's Disease (WPAI-CD) at Weeks 28 and 52

Description

Time Frame

Baseline (Week 0) and Weeks 28 and 52

Title

Receipt of Disability Benefits at Weeks 28 and 52

Description

Time Frame

Weeks 28 and 52

Title

Change From Baseline in Health-related Resource Utilization at Weeks 28 and 52

Description

Time Frame

Baseline (Week 0) and Weeks 28 and 52

Title

Change From Baseline in C Reactive Protein (CRP) at Weeks 28 and 52

Description

Time Frame

Baseline (Week 0 and Weeks 28 and 52

Title

Change From Baseline in Faecal Calprotectin at Weeks 28 and 52

Description

Time Frame

Baseline (Week 0) and Weeks 28 and 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Little Rock

State/Province

Arizona

ZIP/Postal Code

72205

Country

United States

Facility Name

GSK Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

GSK Investigational Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

GSK Investigational Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

GSK Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

GSK Investigational Site

City

Lakewood

State/Province

Colorado

ZIP/Postal Code

80215

Country

United States

Facility Name

GSK Investigational Site

City

Littleton

State/Province

Colorado

ZIP/Postal Code

80120

Country

United States

Facility Name

GSK Investigational Site

City

Hamden

State/Province

Connecticut

ZIP/Postal Code

06518

Country

United States

Facility Name

GSK Investigational Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

GSK Investigational Site

City

Washington, D.C.

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

GSK Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256-6004

Country

United States

Facility Name

GSK Investigational Site

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

GSK Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342-5006

Country

United States

Facility Name

GSK Investigational Site

City

Suwanee

State/Province

Georgia

ZIP/Postal Code

30024

Country

United States

Facility Name

GSK Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

GSK Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46237

Country

United States

Facility Name

GSK Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536-0298

Country

United States

Facility Name

GSK Investigational Site

City

Hammond

State/Province

Louisiana

ZIP/Postal Code

70403

Country

United States

Facility Name

GSK Investigational Site

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71201

Country

United States

Facility Name

GSK Investigational Site

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

Country

United States

Facility Name

GSK Investigational Site

City

Towson

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

GSK Investigational Site

City

Towson

State/Province

Maryland

ZIP/Postal Code

21286

Country

United States

Facility Name

GSK Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

GSK Investigational Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-5682

Country

United States

Facility Name

GSK Investigational Site

City

Chesterfield

State/Province

Michigan

ZIP/Postal Code

48047

Country

United States

Facility Name

GSK Investigational Site

City

Troy

State/Province

Michigan

ZIP/Postal Code

48098

Country

United States

Facility Name

GSK Investigational Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

GSK Investigational Site

City

Lee's Summit

State/Province

Missouri

ZIP/Postal Code

64064

Country

United States

Facility Name

GSK Investigational Site

City

Mexico

State/Province

Missouri

ZIP/Postal Code

65265-3726

Country

United States

Facility Name

GSK Investigational Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11206

Country

United States

Facility Name

GSK Investigational Site

City

East Setauket

State/Province

New York

ZIP/Postal Code

11733-9292

Country

United States

Facility Name

GSK Investigational Site

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

GSK Investigational Site

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

GSK Investigational Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7080

Country

United States

Facility Name

GSK Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

GSK Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

Facility Name

GSK Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

GSK Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

GSK Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

GSK Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74135

Country

United States

Facility Name

GSK Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Facility Name

GSK Investigational Site

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

GSK Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212-1610

Country

United States

Facility Name

GSK Investigational Site

City

Ogden

State/Province

Utah

ZIP/Postal Code

84405

Country

United States

Facility Name

GSK Investigational Site

City

Christiansburg

State/Province

Virginia

ZIP/Postal Code

24073

Country

United States

Facility Name

GSK Investigational Site

City

Danville

State/Province

Virginia

ZIP/Postal Code

24541

Country

United States

Facility Name

GSK Investigational Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

GSK Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249

Country

United States

Facility Name

GSK Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

GSK Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

Facility Name

GSK Investigational Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

GSK Investigational Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

GSK Investigational Site

City

Bankstown

State/Province

New South Wales

ZIP/Postal Code

2200

Country

Australia

Facility Name

GSK Investigational Site

City

Hersten

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

GSK Investigational Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

GSK Investigational Site

City

Kurralta Park

State/Province

South Australia

ZIP/Postal Code

5037

Country

Australia

Facility Name

GSK Investigational Site

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

GSK Investigational Site

City

Fitzroy

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

GSK Investigational Site

City

Prahran

State/Province

Victoria

ZIP/Postal Code

3181

Country

Australia

Facility Name

GSK Investigational Site

City

Fremantle

State/Province

Western Australia

ZIP/Postal Code

6160

Country

Australia

Facility Name

GSK Investigational Site

City

Hall in Tirol

ZIP/Postal Code

6060

Country

Austria

Facility Name

GSK Investigational Site

City

Linz

ZIP/Postal Code

A-4021

Country

Austria

Facility Name

GSK Investigational Site

City

Oberpullendorf

ZIP/Postal Code

7350

Country

Austria

Facility Name

GSK Investigational Site

City

St.Veit/Glan

ZIP/Postal Code

9300

Country

Austria

Facility Name

GSK Investigational Site

City

Wien

ZIP/Postal Code

1030

Country

Austria

Facility Name

GSK Investigational Site

City

Wien

ZIP/Postal Code

1050

Country

Austria

Facility Name

GSK Investigational Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

GSK Investigational Site

City

Bonheiden

ZIP/Postal Code

2820

Country

Belgium

Facility Name

GSK Investigational Site

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

GSK Investigational Site

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

GSK Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

GSK Investigational Site

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

GSK Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

GSK Investigational Site

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

GSK Investigational Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1527

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

GSK Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2X8

Country

Canada

Facility Name

GSK Investigational Site

City

Abbotsford

State/Province

British Columbia

ZIP/Postal Code

V2S 3N5

Country

Canada

Facility Name

GSK Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 2K5

Country

Canada

Facility Name

GSK Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1R9

Country

Canada

Facility Name

GSK Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

GSK Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Facility Name

GSK Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Facility Name

GSK Investigational Site

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 5G2

Country

Canada

Facility Name

GSK Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

GSK Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Facility Name

GSK Investigational Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 1A2

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

GSK Investigational Site

City

Quebec

ZIP/Postal Code

G1S 4L8

Country

Canada

Facility Name

GSK Investigational Site

City

Quebec

ZIP/Postal Code

G3K 2P8

Country

Canada

Facility Name

GSK Investigational Site

City

Vina del Mar

ZIP/Postal Code

2520012

Country

Chile

Facility Name

GSK Investigational Site

City

Hradec Králové

ZIP/Postal Code

500 12

Country

Czechia

Facility Name

GSK Investigational Site

City

Olomouc

ZIP/Postal Code

77520

Country

Czechia

Facility Name

GSK Investigational Site

City

Ostrava - Vitkovice

ZIP/Postal Code

70384

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 4

ZIP/Postal Code

140 21

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 7

ZIP/Postal Code

17004

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 9

ZIP/Postal Code

190 61

Country

Czechia

Facility Name

GSK Investigational Site

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

GSK Investigational Site

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

Facility Name

GSK Investigational Site

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

GSK Investigational Site

City

Hvidovre

ZIP/Postal Code

2605

Country

Denmark

Facility Name

GSK Investigational Site

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

10617

Country

Estonia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

EE-10138

Country

Estonia

Facility Name

GSK Investigational Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Facility Name

GSK Investigational Site

City

Clichy cedex

ZIP/Postal Code

92118

Country

France

Facility Name

GSK Investigational Site

City

Lille cedex

ZIP/Postal Code

59037

Country

France

Facility Name

GSK Investigational Site

City

Nantes cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

GSK Investigational Site

City

Nice cedex 3

ZIP/Postal Code

06202

Country

France

Facility Name

GSK Investigational Site

City

Paris cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

GSK Investigational Site

City

Pessac cedex

ZIP/Postal Code

33604

Country

France

Facility Name

GSK Investigational Site

City

Saint-Priest en Jarez

ZIP/Postal Code

42270

Country

France

Facility Name

GSK Investigational Site

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

GSK Investigational Site

City

Ulm

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

89081

Country

Germany

Facility Name

GSK Investigational Site

City

Frankfurt am Main

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

Facility Name

GSK Investigational Site

City

Brinkum/Stuhr

State/Province

Niedersachsen

ZIP/Postal Code

28816

Country

Germany

Facility Name

GSK Investigational Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30625

Country

Germany

Facility Name

GSK Investigational Site

City

Minden

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

32423

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20148

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22559

Country

Germany

Facility Name

GSK Investigational Site

City

Hong Kong

Country

Hong Kong

Facility Name

GSK Investigational Site

City

Shatin, New Territories

Country

Hong Kong

Facility Name

GSK Investigational Site

City

Bekescsaba

ZIP/Postal Code

5600

Country

Hungary

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1136

Country

Hungary

Facility Name

GSK Investigational Site

City

Debrecen

ZIP/Postal Code

4025

Country

Hungary

Facility Name

GSK Investigational Site

City

Mosonmagyaróvár

ZIP/Postal Code

9200

Country

Hungary

Facility Name

GSK Investigational Site

City

Szekszárd

ZIP/Postal Code

7100

Country

Hungary

Facility Name

GSK Investigational Site

City

Vác

ZIP/Postal Code

2600

Country

Hungary

Facility Name

GSK Investigational Site

City

Afula

ZIP/Postal Code

18101

Country

Israel

Facility Name

GSK Investigational Site

City

Beer Sheva

ZIP/Postal Code

84101

Country

Israel

Facility Name

GSK Investigational Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

GSK Investigational Site

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

GSK Investigational Site

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

GSK Investigational Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

GSK Investigational Site

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

GSK Investigational Site

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

GSK Investigational Site

City

Ramat-Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

GSK Investigational Site

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

GSK Investigational Site

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

GSK Investigational Site

City

Palermo

State/Province

Sicilia

ZIP/Postal Code

90127

Country

Italy

Facility Name

GSK Investigational Site

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

GSK Investigational Site

City

Modena

ZIP/Postal Code

41100

Country

Italy

Facility Name

GSK Investigational Site

City

Roma

ZIP/Postal Code

00152

Country

Italy

Facility Name

GSK Investigational Site

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

GSK Investigational Site

City

Aichi

ZIP/Postal Code

460-0012

Country

Japan

Facility Name

GSK Investigational Site

City

Chiba

ZIP/Postal Code

285-8741

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

818-8502

Country

Japan

Facility Name

GSK Investigational Site

City

Hiroshima

ZIP/Postal Code

720-8520

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

060-0033

Country

Japan

Facility Name

GSK Investigational Site

City

Hyogo

ZIP/Postal Code

663-8501

Country

Japan

Facility Name

GSK Investigational Site

City

Kagoshima

ZIP/Postal Code

892-0846

Country

Japan

Facility Name

GSK Investigational Site

City

Kagoshima

ZIP/Postal Code

892-8512

Country

Japan

Facility Name

GSK Investigational Site

City

Miyagi

ZIP/Postal Code

981-3213

Country

Japan

Facility Name

GSK Investigational Site

City

Osaka

ZIP/Postal Code

530-0011

Country

Japan

Facility Name

GSK Investigational Site

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

169-0073

Country

Japan

Facility Name

GSK Investigational Site

City

Daegu

ZIP/Postal Code

705-717

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Pusan

ZIP/Postal Code

602-739

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

130702

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

135710

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Wonju

ZIP/Postal Code

220701

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

GSK Investigational Site

City

Amsterdam

ZIP/Postal Code

1091 AC

Country

Netherlands

Facility Name

GSK Investigational Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

EDE

ZIP/Postal Code

6716 RP

Country

Netherlands

Facility Name

GSK Investigational Site

City

Eindhoven

ZIP/Postal Code

5623 EJ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

GSK Investigational Site

City

Rotterdam

ZIP/Postal Code

3083 AN

Country

Netherlands

Facility Name

GSK Investigational Site

City

Dunedin

ZIP/Postal Code

9054

Country

New Zealand

Facility Name

GSK Investigational Site

City

Lower Hutt

ZIP/Postal Code

6007

Country

New Zealand

Facility Name

GSK Investigational Site

City

Otahuhu, Auckland

ZIP/Postal Code

2025

Country

New Zealand

Facility Name

GSK Investigational Site

City

Tauranga.

ZIP/Postal Code

3143

Country

New Zealand

Facility Name

GSK Investigational Site

City

Tromsø

ZIP/Postal Code

9038

Country

Norway

Facility Name

GSK Investigational Site

City

Tønsberg

ZIP/Postal Code

3116

Country

Norway

Facility Name

GSK Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

GSK Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-681

Country

Poland

Facility Name

GSK Investigational Site

City

Lublin

ZIP/Postal Code

20-582

Country

Poland

Facility Name

GSK Investigational Site

City

Sopot

ZIP/Postal Code

81-756

Country

Poland

Facility Name

GSK Investigational Site

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

GSK Investigational Site

City

Wroclaw

ZIP/Postal Code

53-333

Country

Poland

Facility Name

GSK Investigational Site

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

GSK Investigational Site

City

Lisboa

ZIP/Postal Code

1769-001

Country

Portugal

Facility Name

GSK Investigational Site

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Facility Name

GSK Investigational Site

City

Viseu

ZIP/Postal Code

3504-509

Country

Portugal

Facility Name

GSK Investigational Site

City

Irkutsk

ZIP/Postal Code

664079

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Kazan

ZIP/Postal Code

420064

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Lipetsk

ZIP/Postal Code

398055

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

129110

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Nizhniy Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Rostov-on-Don

ZIP/Postal Code

344091

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Samara

ZIP/Postal Code

443011

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

196247

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

197047

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Tomsk

ZIP/Postal Code

634063

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Bratislava

ZIP/Postal Code

831 04

Country

Slovakia

Facility Name

GSK Investigational Site

City

Bratislava

ZIP/Postal Code

851 01

Country

Slovakia

Facility Name

GSK Investigational Site

City

Bratislava

ZIP/Postal Code

851 07

Country

Slovakia

Facility Name

GSK Investigational Site

City

Nitra

ZIP/Postal Code

949 01

Country

Slovakia

Facility Name

GSK Investigational Site

City

Nove Mesto nad Vahom

ZIP/Postal Code

915 01

Country

Slovakia

Facility Name

GSK Investigational Site

City

Presov

ZIP/Postal Code

080 01

Country

Slovakia

Facility Name

GSK Investigational Site

City

Trnava

ZIP/Postal Code

917 02

Country

Slovakia

Facility Name

GSK Investigational Site

City

Bellville

ZIP/Postal Code

7530

Country

South Africa

Facility Name

GSK Investigational Site

City

Claremont

ZIP/Postal Code

7708

Country

South Africa

Facility Name

GSK Investigational Site

City

Observatory

ZIP/Postal Code

7925

Country

South Africa

Facility Name

GSK Investigational Site

City

Parktown

ZIP/Postal Code

2192

Country

South Africa

Facility Name

GSK Investigational Site

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

GSK Investigational Site

City

Elche

ZIP/Postal Code

03293

Country

Spain

Facility Name

GSK Investigational Site

City

Fuenlabrada (Madrid)

ZIP/Postal Code

28942

Country

Spain

Facility Name

GSK Investigational Site

City

Galdakao/Vizcaya

ZIP/Postal Code

48960

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

GSK Investigational Site

City

Marbella

ZIP/Postal Code

29600

Country

Spain

Facility Name

GSK Investigational Site

City

Sabadell (Barcelona)

ZIP/Postal Code

08208

Country

Spain

Facility Name

GSK Investigational Site

City

Santander (Cantabria)

ZIP/Postal Code

39008

Country

Spain

Facility Name

GSK Investigational Site

City

Lund

ZIP/Postal Code

SE-221 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Stockholm

ZIP/Postal Code

SE-171 76

Country

Sweden

Facility Name

GSK Investigational Site

City

Stockholm

ZIP/Postal Code

SE-182 88

Country

Sweden

Facility Name

GSK Investigational Site

City

Bern

ZIP/Postal Code

3004

Country

Switzerland

Facility Name

GSK Investigational Site

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

GSK Investigational Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

GSK Investigational Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

GSK Investigational Site

City

Chernivtsi

ZIP/Postal Code

58005

Country

Ukraine

Facility Name

GSK Investigational Site

City

Dnipropetrovsk

ZIP/Postal Code

49044

Country

Ukraine

Facility Name

GSK Investigational Site

City

Donetsk

ZIP/Postal Code

83003

Country

Ukraine

Facility Name

GSK Investigational Site

City

Donetsk

ZIP/Postal Code

83017

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kharkiv

ZIP/Postal Code

61037

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

Country

Ukraine

Facility Name

GSK Investigational Site

City

Odesa

ZIP/Postal Code

65117

Country

Ukraine

Facility Name

GSK Investigational Site

City

Simferopol

ZIP/Postal Code

95017

Country

Ukraine

Facility Name

GSK Investigational Site

City

Vinnytsya

ZIP/Postal Code

21029

Country

Ukraine

Facility Name

GSK Investigational Site

City

Harrow

State/Province

Middlesex

ZIP/Postal Code

HA1 3UJ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bristol

ZIP/Postal Code

BS2 8HW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Newcastle-upon-Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Oxford

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Salford

ZIP/Postal Code

M6 8HD

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease

We'll reach out to this number within 24 hrs

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

Crohn's Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial