Open-Label Extension Study of GSK1605786A (SHIELD-3)

August 16, 2017 updated by: GlaxoSmithKline

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects With Crohn's Disease

An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment change may be eligible to participate. The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.

Study Overview

Status

Terminated

Conditions

Crohn's Disease

Intervention / Treatment

Drug: GSK1605786A

Detailed Description

This is a multi-centre, open-label extension study to assess the long-term safety, tolerability and effectiveness of GSK1605786A in subjects with Crohn's disease. Subjects will enter the study via one of three routes:

completion of the placebo-controlled induction study, CCX114151, without achieving clinical response (CDAI decrease of at least 100 points) or clinical remission (CDAI score less than 150) at Week 12 or completion of any other GSK-sponsored induction study as designated by the sponsor
completion of maintenance study CCX114157 at Week 52
withdrawal from maintenance study CCX114157 due to worsening of Crohn's disease and requiring a treatment change.

The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and disability.

It is estimated that approximately 800 subjects will be enrolled in total. All subjects will enter the study at baseline (Week 0) and commence oral treatment with GSK1605786A 500 mg twice daily.

The study will be conducted for 108 weeks. Once the results of the induction study CCX114151 are known, the risk-to-benefit ratio will be re-assessed and the study duration may be amended.

Study assessments for Crohn's disease will be performed every 12 weeks through Week 108. At week 12, the investigator will make a determination of whether the subject is receiving clinical benefit, and subjects who are not receiving clinical benefit must be withdrawn. More frequent blood draws are required for liver function testing only; every 2 weeks for the first 12 weeks, then every 4 weeks up to Week 52, and every 12 weeks after Week 60 for the duration of the study.

Study Type

Interventional

Enrollment (Actual)

399

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- New South Wales
  - Bankstown, New South Wales, Australia, 2200
    - GSK Investigational Site
- Queensland
  - Hersten, Queensland, Australia, 4029
    - GSK Investigational Site
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - GSK Investigational Site
  - Kurralta Park, South Australia, Australia, 5037
    - GSK Investigational Site
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - GSK Investigational Site
  - Fitzroy, Victoria, Australia, 3065
    - GSK Investigational Site
  - Prahran, Victoria, Australia, 3181
    - GSK Investigational Site
- Western Australia
  - Fremantle, Western Australia, Australia, 6160
    - GSK Investigational Site
Austria
- - 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
    - GSK Investigational Site
Belgium
- - 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
    - GSK Investigational Site
Bulgaria
- - Plovdiv, Bulgaria, 4002
    - GSK Investigational Site
  - Sofia, Bulgaria, 1431
    - GSK Investigational Site
  - Sofia, Bulgaria, 1407
    - GSK Investigational Site
  - Sofia, Bulgaria, 1527
    - GSK Investigational Site
  - Varna, Bulgaria, 9010
    - GSK Investigational Site
Canada
- - Quebec, Canada, G1S 4L8
    - GSK Investigational Site
  - Quebec, Canada, G3K 2P8
    - GSK Investigational Site
- Alberta
  - Calgary, Alberta, Canada, T2N 4Z6
    - GSK Investigational Site
  - Edmonton, Alberta, Canada, T6G 2X8
    - GSK Investigational Site
- British Columbia
  - Abbotsford, British Columbia, Canada, V2S 3N5
    - GSK Investigational Site
  - Vancouver, British Columbia, Canada, V6Z 2K5
    - GSK Investigational Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R3A 1R9
    - GSK Investigational Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - GSK Investigational Site
- Ontario
  - 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
    - GSK Investigational Site
- Quebec
  - Montreal, Quebec, Canada, H3A 1A1
    - GSK Investigational Site
  - Montreal, Quebec, Canada, H3T 1E2
    - GSK Investigational Site
Chile
- - Vina del Mar, Chile, 2520012
    - GSK Investigational Site
Czechia
- - 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
    - GSK Investigational Site
Denmark
- - 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
    - GSK Investigational Site
Estonia
- - Tallinn, Estonia, 10617
    - GSK Investigational Site
  - Tallinn, Estonia, EE-10138
    - GSK Investigational Site
  - Tartu, Estonia, 51014
    - GSK Investigational Site
France
- - 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
    - GSK Investigational Site
Germany
- - Berlin, Germany, 10117
    - GSK Investigational Site
  - Berlin, Germany, 13353
    - GSK Investigational Site
  - Hamburg, Germany, 20148
    - GSK Investigational Site
  - Hamburg, Germany, 22559
    - GSK Investigational Site
- Baden-Wuerttemberg
  - Ulm, Baden-Wuerttemberg, Germany, 89081
    - GSK Investigational Site
- Hessen
  - Frankfurt am Main, Hessen, Germany, 60590
    - GSK Investigational Site
- Niedersachsen
  - Hannover, Niedersachsen, Germany, 30625
    - GSK Investigational Site
- Nordrhein-Westfalen
  - Minden, Nordrhein-Westfalen, Germany, 32423
    - GSK Investigational Site
Hong Kong
- - Hong Kong, Hong Kong
    - GSK Investigational Site
  - Shatin, New Territories, Hong Kong
    - GSK Investigational Site
Hungary
- - 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
    - GSK Investigational Site
Israel
- - 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
    - GSK Investigational Site
Italy
- - Modena, Italy, 41100
    - GSK Investigational Site
  - Roma, Italy, 00152
    - GSK Investigational Site
- Liguria
  - Genova, Liguria, Italy, 16132
    - GSK Investigational Site
- Sicilia
  - Palermo, Sicilia, Italy, 90127
    - GSK Investigational Site
Japan
- - 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
    - GSK Investigational Site
Korea, Republic of
- - Busan, Korea, Republic of
    - GSK Investigational Site
  - Daegu, Korea, Republic of, 705-717
    - 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
    - GSK Investigational Site
New Zealand
- - 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
    - GSK Investigational Site
Poland
- - Bydgoszcz, Poland, 85-168
    - GSK Investigational Site
  - Bydgoszcz, Poland, 85-681
    - GSK Investigational Site
  - Lublin, Poland, 20-607
    - GSK Investigational Site
  - Sopot, Poland, 81-756
    - GSK Investigational Site
  - Torun, Poland, 87-100
    - GSK Investigational Site
  - Wroclaw, Poland, 53-333
    - GSK Investigational Site
Portugal
- - 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
    - GSK Investigational Site
Russian Federation
- - 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
    - GSK Investigational Site
Slovakia
- - 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
    - GSK Investigational Site
South Africa
- - 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
    - GSK Investigational Site
Spain
- - Badalona, Spain, 08916
    - GSK Investigational Site
  - Elche, Spain, 03293
    - GSK Investigational Site
  - Fuenlabrada (Madrid), Spain, 28942
    - 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, Spain, 39008
    - GSK Investigational Site
Sweden
- - Lund, Sweden, SE-221 85
    - GSK Investigational Site
  - Stockholm, Sweden, SE-171 76
    - GSK Investigational Site
  - Stockholm, Sweden, SE-182 88
    - GSK Investigational Site
Switzerland
- - Bern, Switzerland, 3004
    - GSK Investigational Site
  - Zürich, Switzerland, 8091
    - GSK Investigational Site
Taiwan
- - Taichung, Taiwan, 40705
    - GSK Investigational Site
Turkey
- - Ankara, Turkey, 06100
    - GSK Investigational Site
Ukraine
- - 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
    - GSK Investigational Site
United Kingdom
- - 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
    - GSK Investigational Site
- Middlesex
  - Harrow, Middlesex, United Kingdom, HA1 3UJ
    - GSK Investigational Site
United States
- Arizona
  - Little Rock, Arizona, United States, 72205
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85712
    - GSK Investigational Site
- California
  - Anaheim, California, United States, 92801
    - 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
    - GSK Investigational Site
- Colorado
  - Aurora, Colorado, United States, 80045
    - GSK Investigational Site
  - Lakewood, Colorado, United States, 80215
    - GSK Investigational Site
  - Littleton, Colorado, United States, 80120
    - GSK Investigational Site
- Connecticut
  - Hamden, Connecticut, United States, 06518
    - GSK Investigational Site
  - New Haven, Connecticut, United States, 06510
    - GSK Investigational Site
- District of Columbia
  - Washington, D.C., District of Columbia, United States, 20007
    - GSK Investigational Site
- Florida
  - Jacksonville, Florida, United States, 32256-6004
    - GSK Investigational Site
  - Port Orange, Florida, United States, 32127
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30342-5006
    - GSK Investigational Site
  - Suwanee, Georgia, United States, 30024
    - GSK Investigational Site
- Illinois
  - Chicago, Illinois, United States, 60637
    - GSK Investigational Site
- Indiana
  - Indianapolis, Indiana, United States, 46237
    - GSK Investigational Site
- Kentucky
  - Lexington, Kentucky, United States, 40536-0298
    - GSK Investigational Site
- Louisiana
  - Hammond, Louisiana, United States, 70403
    - GSK Investigational Site
  - Monroe, Louisiana, United States, 71201
    - GSK Investigational Site
- Maryland
  - Chevy Chase, Maryland, United States, 20815
    - GSK Investigational Site
  - Towson, Maryland, United States, 21204
    - GSK Investigational Site
  - Towson, Maryland, United States, 21286
    - GSK Investigational Site
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - GSK Investigational Site
- Michigan
  - Ann Arbor, Michigan, United States, 48109-5682
    - GSK Investigational Site
  - Chesterfield, Michigan, United States, 48047
    - GSK Investigational Site
  - Troy, Michigan, United States, 48098
    - GSK Investigational Site
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - GSK Investigational Site
- Missouri
  - Lee's Summit, Missouri, United States, 64064
    - GSK Investigational Site
  - Mexico, Missouri, United States, 65265-3726
    - GSK Investigational Site
- New York
  - 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
    - GSK Investigational Site
- North Carolina
  - 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
    - GSK Investigational Site
- Ohio
  - Columbus, Ohio, United States, 43215
    - GSK Investigational Site
- Oklahoma
  - Tulsa, Oklahoma, United States, 74135
    - GSK Investigational Site
- Oregon
  - Portland, Oregon, United States, 97225
    - GSK Investigational Site
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15212
    - GSK Investigational Site
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - GSK Investigational Site
  - Nashville, Tennessee, United States, 37212-1610
    - GSK Investigational Site
- Utah
  - Ogden, Utah, United States, 84405
    - GSK Investigational Site
- Virginia
  - 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
    - GSK Investigational Site
- Washington
  - Seattle, Washington, United States, 98101
    - GSK Investigational Site
  - Seattle, Washington, United States, 98195
    - GSK Investigational Site
- Wisconsin
  - Madison, Wisconsin, United States, 53792
    - GSK Investigational Site
  - Milwaukee, Wisconsin, United States, 53226
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Previous participation in a GSK-sponsored study with GSK1605786A
Written informed consent prior to any study-specific procedures
Female subjects: To be eligible, females of child-bearing potential must be sexually inactive or commit to consistent and correct use of a contraceptive method of birth control with less than 1% failure rate

Exclusion Criteria:

If female, is pregnant, has a positive pregnancy test or is breast-feeding, or is planning to become pregnant
Subjects with known or suspected coeliac disease or a positive screening test for anti-tissue transglutaminase antibodies should have been excluded from enrolment into any induction study. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tissue transglutaminase antibodies and excluded or withdrawn from the study upon positive test result
Fixed symptomatic stenoses or strictures of small bowel or colon
Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period
Current sepsis or infections requiring intravenous antibiotic therapy greater than 2 weeks
Evidence of hepatic dysfunction or viral hepatitis
Subjects who have demonstrated safety or tolerability issues during participation in a previous study with GSK1605786A which, in the opinion of the investigator, was possibly related to study treatment and poses an unacceptable risk to the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GSK1605786A 500 milligrams twice daily	Drug: GSK1605786A 500 milligrams twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE) Time Frame: Up to Week 112	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. The Safety population consisted of all participants who enrolled in the study except those who did not take >=1 dose of investigational product.	Up to Week 112

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline (Week 0) in Systolic and Diastolic Blood Pressure (SBP and DBP) Over Period Time Frame: Baseline (Week 0) and up to Week 112	The SBP and DBP values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Baseline value was recorded at Week 0. Change from Baseline measurements in SBP and DBP were assessed at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.	Baseline (Week 0) and up to Week 112
Change From Baseline (Week 0) in Heart Rate (HR) Over Period Time Frame: Baseline (week 0) and up to Week 112	The HR values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Change from Baseline in HR was assessed at Week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.	Baseline (week 0) and up to Week 112
Number of Participants With Shifts From Baseline (Week 0) for the Indicated Hematology Parameters Time Frame: Baseline (Week 0) and up to Week 112	Hematology parameters measured included platelets, neutrophils (NL), lymphocytes, monocytes, eosinophils, basophils, hematocrit, band cells, red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count, and segmented (seg) NL. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated hematology parameters data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, shift to high) until 4 weeks post treatment are presented.	Baseline (Week 0) and up to Week 112
Number of Participants With Shifts From Baseline (Week 0) for the Indicated Clinical Chemistry Parameters Time Frame: Baseline (Week 0) and up to Week 112	Clinical chemistry parameters included platelets, total protein, phosphorous, albumin, sodium, potassium, chloride, calcium, glucose, gamma-glutamyl transferase, total bilirubin (TB), direct bilirubin (DB), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN)/urea, creatinine, uric acid, bicarbonate, lactate dehydrogenase, cholesterol, alkaline phosphatase (ALP), gamma glutamyl transferases (GGT), and creatine kinase. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated clinical chemistry parameters' data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, or shift to high) until 4 weeks post-treatment are presented.	Baseline (Week 0) and up to Week 112
Change From Baseline (Week 0) in ALT, AST, ALP, and GGT as a Function of Liver Function Test (LFT) Time Frame: Baseline (Week 0) and up to Week 112	Changes in Baseline in ALP, ALT, AST, and GGT were assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.	Baseline (Week 0) and up to Week 112
Change From Baseline (Week 0) in Total Bilirubin Time Frame: Baseline (Week 0) and up to Week 112	Changes from Baseline (Week 0) in total bilirubin (TB) was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.	Baseline (Week 0) and up to Week 112
Change From Baseline (Week 0) in Albumin Time Frame: Baseline (Week 0) and up to Week 112	Change from Baseline in albumin was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post treatment. The last value on or prior to the treatment start date (Week 0) was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.	Baseline (Week 0) and up to Week 112
Number of Participants With the Indicated Change From Baseline (Week 0) in Corrected QT Interval (QTc) Value Time Frame: Baseline (week 0) and Weeks 24, 48, 72, 108, and 112 (4 weeks post treatment)	QTc is the corrected QT interval as measured by the electrocardiogram (ECG). ECG parameters including the change from Baseline in the QTc interval values QTcF and QTcB were summarised. The QTcF is Fridericia's formula and defined as the QT interval/cubed root of the R-R interval. The QTcB is the Bazett's formula defined as the QT/squared root of the R-R interval. The number of participants with change from Baseline in the QTcF and QTcB intervals of >30, 30 to <60 and >=60 milliseconds were assessed at Week 24, 48, 72, 108, and Week 112. The last value on or prior to the treatment start date was considered the Baseline value (Week 0). Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.	Baseline (week 0) and Weeks 24, 48, 72, 108, and 112 (4 weeks post treatment)
Change From Baseline (Week 0) in Crohn's Disease Activity Index (CDAI) Score Over 108 Weeks Time Frame: Baseline (Week 0) and up to 108 weeks	The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant,investigator entries, standardized weight determination, and Hematocrit values received from the central laboratory. The Baseline CDAI score was recorded pre-dose on Week 0. Change from Baseline is the value at indicated time point minus the Baseline value. Remissions are defined as participants with CDAI score of < 150 points. No imputation for missing data was performed. The assessment was based on questionnaire like number of liquid stool in past 7 days, abdominal pain, other symptoms, antidiarrheal use, abdominal mass, anemia, and body weight. The total score is summation of all individual sub-scores. CDAI scoring scale ranges from 0-500 and a score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline (Week 0) and up to 108 weeks
Percentage of Participants in Clinical Remission (CDAI Score Less Than 150) for All Participants, for Participants in Remission at Baseline (Week 0), and for Participants Not in Remission at Baseline Over 108 Weeks Time Frame: Baseline (Week 0) and up to 108 weeks	The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product is taken. The CDAI score was measured over 108 weeks although it was planned to be measured till 112 weeks. Remissions are defined as subjects with CDAI score of < 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed. Combined data for participants with remission at Baseline and without remission at Baseline has been presented.	Baseline (Week 0) and up to 108 weeks
Percentage of Participants Achieving Response (CDAI Decrease of at Least 100 Points From Baseline ([Week 0] of Prior Induction Study) in the Sub-population of Non-responders at Study Entry Over 112 Weeks Time Frame: Baseline (Week 0) and up to 112 weeks	The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product was taken. Remissions are defined as subjects with CDAI score of < 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed.	Baseline (Week 0) and up to 112 weeks
Change From Baseline (Week 0) in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form Health Survey (SF-36) Version 2, EuroQol 5 Dimensional (EQ-5D), Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and Disability Over 112 Weeks Time Frame: Baseline (Week 0) and up to 112 weeks	IBDQ, SF-36, EQ-5D, WPAI-CD, and disability scores were all health outcome related scores that were based on assessment of participants based on different questionnaire. Each scoring scale had different range and participants were planned to be rated separately based on each scale.	Baseline (Week 0) and up to 112 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

October 29, 2013

Study Registration Dates

First Submitted

March 3, 2011

First Submitted That Met QC Criteria

March 17, 2011

First Posted (Estimate)

March 21, 2011

Study Record Updates

Last Update Posted (Actual)

September 14, 2017

Last Update Submitted That Met QC Criteria

August 16, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

GSK1605786A; Inflammatory Bowel Disease; Crohn's disease; long-term treatment; quality of life; CCR9 antagonist

Additional Relevant MeSH Terms

Other Study ID Numbers

114644
2010-022384-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Open-Label Extension Study of GSK1605786A (SHIELD-3)

An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects With Crohn's Disease

Study Overview

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Intervention / Treatment

Detailed Description

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Primary Outcome Measures

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Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Crohn's Disease

Clinical Trials on GSK1605786A

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