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AzTrials

Crohn's DiseasePhase 3SHIELD-3NCT01318993

Open-Label Extension Study of GSK1605786A

A Phase 3 study testing GSK1605786A in people with Crohn's Disease, run by GlaxoSmithKline at 244 sites in 31 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 (maintenance study of GSK1605786A) due to… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
GSK1605786A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
399 participants
Where
244 sitesin 31 countries
Study dates
1 Apr 2011to 29 Oct 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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coeliac disease is subsequently suspected should be tested for anti-tissue transglutaminase antibodies and excluded or withdrawn from the study upon positive test result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.

Trial locations and contacts

244 sites in 31 countries.

244 sites in 31 countries

United States55 sites

  • GSK Investigational Site

    Anaheim, California, 92801

  • GSK Investigational Site

    Ann Arbor, Michigan, 48109-5682

  • GSK Investigational Site

    Atlanta, Georgia, 30342-5006

  • GSK Investigational Site

    Aurora, Colorado, 80045

  • GSK Investigational Site

    Boston, Massachusetts, 02114

  • GSK Investigational Site

    Brooklyn, New York, 11206

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599-7080

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Charlotte, North Carolina, 28209

  • GSK Investigational Site

    Chesterfield, Michigan, 48047

  • GSK Investigational Site

    Chevy Chase, Maryland, 20815

  • GSK Investigational Site

    Chicago, Illinois, 60637

  • GSK Investigational Site

    Christiansburg, Virginia, 24073

  • GSK Investigational Site

    Columbus, Ohio, 43215

  • GSK Investigational Site

    Danville, Virginia, 24541

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    East Setauket, New York, 11733-9292

  • GSK Investigational Site

    Germantown, Tennessee, 38138

  • GSK Investigational Site

    Great Neck, New York, 11021

  • GSK Investigational Site

    Hamden, Connecticut, 06518

  • GSK Investigational Site

    Hammond, Louisiana, 70403

  • GSK Investigational Site

    Indianapolis, Indiana, 46237

  • GSK Investigational Site

    Jacksonville, Florida, 32256-6004

  • GSK Investigational Site

    La Jolla, California, 92093

  • GSK Investigational Site

    Lake Success, New York, 11042

  • GSK Investigational Site

    Lakewood, Colorado, 80215

  • GSK Investigational Site

    Lee's Summit, Missouri, 64064

  • GSK Investigational Site

    Lexington, Kentucky, 40536-0298

  • GSK Investigational Site

    Little Rock, Arizona, 72205

  • GSK Investigational Site

    Littleton, Colorado, 80120

  • GSK Investigational Site

    Madison, Wisconsin, 53792

  • GSK Investigational Site

    Mexico, Missouri, 65265-3726

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53226

  • GSK Investigational Site

    Monroe, Louisiana, 71201

  • GSK Investigational Site

    Nashville, Tennessee, 37212-1610

  • GSK Investigational Site

    New Haven, Connecticut, 06510

  • GSK Investigational Site

    Norfolk, Virginia, 23502

  • GSK Investigational Site

    Ogden, Utah, 84405

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • GSK Investigational Site

    Port Orange, Florida, 32127

  • GSK Investigational Site

    Portland, Oregon, 97225

  • GSK Investigational Site

    Raleigh, North Carolina, 27612

  • GSK Investigational Site

    Richmond, Virginia, 23249

  • GSK Investigational Site

    Rochester, Minnesota, 55905

  • GSK Investigational Site

    San Diego, California, 92103

  • GSK Investigational Site

    San Francisco, California, 94115

  • GSK Investigational Site

    Seattle, Washington, 98101

  • GSK Investigational Site

    Seattle, Washington, 98195

  • GSK Investigational Site

    Suwanee, Georgia, 30024

  • GSK Investigational Site

    Towson, Maryland, 21204

  • GSK Investigational Site

    Towson, Maryland, 21286

  • GSK Investigational Site

    Troy, Michigan, 48098

  • GSK Investigational Site

    Tucson, Arizona, 85712

  • GSK Investigational Site

    Tulsa, Oklahoma, 74135

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20007

Other trials in United States

Canada16 sites

  • GSK Investigational Site

    Abbotsford British Columbia, British Columbia, V2S 3N5

  • GSK Investigational Site

    Calgary, Alberta, T2N 4Z6

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2X8

  • GSK Investigational Site

    Halifax, Nova Scotia, B3H 2Y9

  • GSK Investigational Site

    Hamilton, Ontario, L8N 3Z5

  • GSK Investigational Site

    Hamilton, Ontario, L8N 4A6

  • GSK Investigational Site

    Kingston, Ontario, K7L 5G2

  • GSK Investigational Site

    London, Ontario, N6A 5A5

  • GSK Investigational Site

    London, Ontario, N6A 5W9

  • GSK Investigational Site

    Montreal, Quebec, H3A 1A1

  • GSK Investigational Site

    Montreal, Quebec, H3T 1E2

  • GSK Investigational Site

    Ottawa, Ontario, K1H 1A2

  • GSK Investigational Site

    Québec, Quebec, G1S 4L8

  • GSK Investigational Site

    Québec, Quebec, G3K 2P8

  • GSK Investigational Site

    Vancouver, British Columbia, V6Z 2K5

  • GSK Investigational Site

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Japan14 sites

  • GSK Investigational Site

    Aichi, 460-0012

  • GSK Investigational Site

    Chiba, 285-8741

  • GSK Investigational Site

    Fukuoka, 812-8582

  • GSK Investigational Site

    Fukuoka, 818-8502

  • GSK Investigational Site

    Hiroshima, 720-8520

  • GSK Investigational Site

    Hokkaido, 060-0033

  • GSK Investigational Site

    Hyōgo, 663-8501

  • GSK Investigational Site

    Kagoshima, 892-0846

  • GSK Investigational Site

    Kagoshima, 892-8512

  • GSK Investigational Site

    Miyagi, 981-3213

  • GSK Investigational Site

    Osaka, 530-0011

  • GSK Investigational Site

    Osaka, 545-8586

  • GSK Investigational Site

    Tokyo, 160-8582

  • GSK Investigational Site

    Tokyo, 169-0073

Other trials in Japan

Israel11 sites

  • GSK Investigational Site

    Afula, 18101

  • GSK Investigational Site

    Beersheba, 84101

  • GSK Investigational Site

    Haifa, 31096

  • GSK Investigational Site

    Holon, 58100

  • GSK Investigational Site

    Jerusalem, 91031

  • GSK Investigational Site

    Jerusalem, 91120

  • GSK Investigational Site

    Kfar Saba, 44281

  • GSK Investigational Site

    Petah Tikva, 49100

  • GSK Investigational Site

    Ramat Gan, 52621

  • GSK Investigational Site

    Tel Aviv, 64239

  • GSK Investigational Site

    Tsrifin, 70300

Other trials in Israel

Spain10 sites

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Elche, 03293

  • GSK Investigational Site

    Fuenlabrada (Madrid), 28942

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Marbella, 29600

  • GSK Investigational Site

    Sabadell (Barcelona), 08208

  • GSK Investigational Site

    Santander, 39008

Other trials in Spain

Russia9 sites

  • GSK Investigational Site

    Kazan', 420064

  • GSK Investigational Site

    Lipetsk, 398055

  • GSK Investigational Site

    Moscow, 129110

  • GSK Investigational Site

    Nizhny Novgorod, 603126

  • GSK Investigational Site

    Rostov-on-Don, 344091

  • GSK Investigational Site

    Saint Petersburg, 196247

  • GSK Investigational Site

    Saint Petersburg, 197047

  • GSK Investigational Site

    Samara, 443011

  • GSK Investigational Site

    Tomsk, 634063

Other trials in Russia

Ukraine9 sites

  • GSK Investigational Site

    Chernivtsi, 58005

  • GSK Investigational Site

    Dnipropetrovsk, 49044

  • GSK Investigational Site

    Donetsk, 83003

  • GSK Investigational Site

    Donetsk, 83017

  • GSK Investigational Site

    Kharkiv, 61037

  • GSK Investigational Site

    Kyiv

  • GSK Investigational Site

    Odesa, 65117

  • GSK Investigational Site

    Simferopol, 95017

  • GSK Investigational Site

    Vinnytsia, 21029

Other trials in Ukraine

Australia8 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Bankstown, New South Wales, 2200

  • GSK Investigational Site

    Box Hill, Victoria, 3128

  • GSK Investigational Site

    Fitzroy, Victoria, 3065

  • GSK Investigational Site

    Fremantle, Western Australia, 6160

  • GSK Investigational Site

    Hersten, Queensland, 4029

  • GSK Investigational Site

    Kurralta Park, South Australia, 5037

  • GSK Investigational Site

    Prahran, Victoria, 3181

Other trials in Australia

France8 sites

  • GSK Investigational Site

    Clichy, 92118

  • GSK Investigational Site

    Lille, 59037

  • GSK Investigational Site

    Nantes, 44093

  • GSK Investigational Site

    Nice, 06202

  • GSK Investigational Site

    Paris, 75475

  • GSK Investigational Site

    Pessac, 33604

  • GSK Investigational Site

    Saint-Priest-en-Jarez, 42270

  • GSK Investigational Site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Germany8 sites

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 13353

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60590

  • GSK Investigational Site

    Hamburg, 20148

  • GSK Investigational Site

    Hamburg, 22559

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

  • GSK Investigational Site

    Minden, North Rhine-Westphalia, 32423

  • GSK Investigational Site

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Hungary8 sites

  • GSK Investigational Site

    Békéscsaba, 5600

  • GSK Investigational Site

    Budapest, 1062

  • GSK Investigational Site

    Budapest, 1083

  • GSK Investigational Site

    Budapest, 1136

  • GSK Investigational Site

    Debrecen, 4025

  • GSK Investigational Site

    Mosonmagyaróvár, 9200

  • GSK Investigational Site

    Szekszárd, 7100

  • GSK Investigational Site

    Vác, 2600

Other trials in Hungary

United Kingdom8 sites

  • GSK Investigational Site

    Birmingham, B9 5SS

  • GSK Investigational Site

    Bristol, BS2 8HW

  • GSK Investigational Site

    Edinburgh, EH4 2XU

  • GSK Investigational Site

    Harrow, Middlesex, HA1 3UJ

  • GSK Investigational Site

    Manchester, M13 9WL

  • GSK Investigational Site

    Newcastle upon Tyne, NE1 4LP

  • GSK Investigational Site

    Oxford, OX3 9DU

  • GSK Investigational Site

    Salford, M6 8HD

Other trials in United Kingdom

Austria7 sites

  • GSK Investigational Site

    Hall in Tirol, 6060

  • GSK Investigational Site

    Linz, A-4021

  • GSK Investigational Site

    Oberpullendorf, 7350

  • GSK Investigational Site

    St.Veit/Glan, 9300

  • GSK Investigational Site

    Vienna, 1030

  • GSK Investigational Site

    Vienna, 1050

  • GSK Investigational Site

    Vienna, 1090

Other trials in Austria

Belgium7 sites

  • GSK Investigational Site

    Bonheiden, 2820

  • GSK Investigational Site

    Brussels, 1000

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Kortrijk, 8500

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Roeselare, 8800

Other trials in Belgium

Czechia7 sites

  • GSK Investigational Site

    Hradec Králové, 500 12

  • GSK Investigational Site

    Olomouc, 77520

  • GSK Investigational Site

    Ostrava - Vitkovice, 70384

  • GSK Investigational Site

    Prague, 100 34

  • GSK Investigational Site

    Prague, 140 21

  • GSK Investigational Site

    Prague, 17004

  • GSK Investigational Site

    Prague, 190 61

Other trials in Czechia

Slovakia7 sites

  • GSK Investigational Site

    Bratislava, 831 04

  • GSK Investigational Site

    Bratislava, 851 01

  • GSK Investigational Site

    Bratislava, 851 07

  • GSK Investigational Site

    Nitra, 949 01

  • GSK Investigational Site

    Nové Mesto nad Váhom, 915 01

  • GSK Investigational Site

    Prešov, 080 01

  • GSK Investigational Site

    Trnava, 917 02

Other trials in Slovakia

South Korea7 sites

  • GSK Investigational Site

    Busan

  • GSK Investigational Site

    Daegu, 705-717

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul, 130702

  • GSK Investigational Site

    Seoul, 135710

  • GSK Investigational Site

    Seoul, 138-736

  • GSK Investigational Site

    Wŏnju, 220701

Other trials in South Korea

Poland6 sites

  • GSK Investigational Site

    Bydgoszcz, 85-168

  • GSK Investigational Site

    Bydgoszcz, 85-681

  • GSK Investigational Site

    Lublin, 20-607

  • GSK Investigational Site

    Sopot, 81-756

  • GSK Investigational Site

    Torun, 87-100

  • GSK Investigational Site

    Wroclaw, 53-333

Other trials in Poland

Bulgaria5 sites

  • GSK Investigational Site

    Plovdiv, 4002

  • GSK Investigational Site

    Sofia, 1407

  • GSK Investigational Site

    Sofia, 1431

  • GSK Investigational Site

    Sofia, 1527

  • GSK Investigational Site

    Varna, 9010

Other trials in Bulgaria

Denmark5 sites

  • GSK Investigational Site

    Aalborg, 9000

  • GSK Investigational Site

    Aarhus, 8000

  • GSK Investigational Site

    Herlev, 2730

  • GSK Investigational Site

    Hvidovre, 2605

  • GSK Investigational Site

    Odense, 5000

Other trials in Denmark

Italy4 sites

  • GSK Investigational Site

    Genoa, Liguria, 16132

  • GSK Investigational Site

    Modena, 41100

  • GSK Investigational Site

    Palermo, Sicily, 90127

  • GSK Investigational Site

    Roma, 00152

Other trials in Italy

New Zealand4 sites

  • GSK Investigational Site

    Dunedin, 9054

  • GSK Investigational Site

    Lower Hutt, 6007

  • GSK Investigational Site

    Otahuhu, Auckland, 2025

  • GSK Investigational Site

    Tauranga, 3143

Other trials in New Zealand

Portugal4 sites

  • GSK Investigational Site

    Lisbon, 1649-035

  • GSK Investigational Site

    Lisbon, 1769-001

  • GSK Investigational Site

    Porto, 4099-001

  • GSK Investigational Site

    Viseu, 3504-509

Other trials in Portugal

South Africa4 sites

  • GSK Investigational Site

    Bellville, 7530

  • GSK Investigational Site

    Claremont, 7708

  • GSK Investigational Site

    Observatory, 7925

  • GSK Investigational Site

    Parktown, 2192

Other trials in South Africa

Estonia3 sites

  • GSK Investigational Site

    Tallinn, 10617

  • GSK Investigational Site

    Tallinn, EE-10138

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

Sweden3 sites

  • GSK Investigational Site

    Lund, SE-221 85

  • GSK Investigational Site

    Stockholm, SE-171 76

  • GSK Investigational Site

    Stockholm, SE-182 88

Other trials in Sweden

Hong Kong2 sites

  • GSK Investigational Site

    Hong Kong

  • GSK Investigational Site

    Shatin, New Territories

Other trials in Hong Kong

Switzerland2 sites

  • GSK Investigational Site

    Bern, 3004

  • GSK Investigational Site

    Zurich, 8091

Other trials in Switzerland

Chile1 site

  • GSK Investigational Site

    Viña del Mar, 2520012

Other trials in Chile

Taiwan1 site

  • GSK Investigational Site

    Taichung, 40705

Other trials in Taiwan

Turkey (Türkiye)1 site

  • GSK Investigational Site

    Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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:

  1. 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
  2. completion of maintenance study CCX114157 at Week 52
  3. 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.

Conditions
Crohn's Disease
Being tested
GSK1605786A
Keywords
GSK1605786A; Inflammatory Bowel Disease; Crohn's disease; long-term treatment; quality of life; CCR9 antagonist
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK1605786ADrug

    500 milligrams twice daily

Study groups in NCT01318993
Study groupRoleWhat they receive
GSK1605786AExperimental500 milligrams twice daily
Receives: Drug: GSK1605786A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE)

    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.

    Measured: Up to Week 112

Secondary outcomes (12)

  1. Change From Baseline (Week 0) in Systolic and Diastolic Blood Pressure (SBP and DBP) Over Period

    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.

    Measured: Baseline (Week 0) and up to Week 112

  2. Change From Baseline (Week 0) in Heart Rate (HR) Over Period

    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.

    Measured: Baseline (week 0) and up to Week 112

  3. Number of Participants With Shifts From Baseline (Week 0) for the Indicated Hematology Parameters

    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.

    Measured: Baseline (Week 0) and up to Week 112

  4. Number of Participants With Shifts From Baseline (Week 0) for the Indicated Clinical Chemistry Parameters

    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.

    Measured: Baseline (Week 0) and up to Week 112

  5. Change From Baseline (Week 0) in ALT, AST, ALP, and GGT as a Function of Liver Function Test (LFT)

    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.

    Measured: Baseline (Week 0) and up to Week 112

  6. Change From Baseline (Week 0) in Total Bilirubin

    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.

    Measured: Baseline (Week 0) and up to Week 112

  7. Change From Baseline (Week 0) in Albumin

    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.

    Measured: Baseline (Week 0) and up to Week 112

  8. Number of Participants With the Indicated Change From Baseline (Week 0) in Corrected QT Interval (QTc) Value

    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.

    Measured: Baseline (week 0) and Weeks 24, 48, 72, 108, and 112 (4 weeks post treatment)

  9. Change From Baseline (Week 0) in Crohn's Disease Activity Index (CDAI) Score Over 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.

    Measured: Baseline (Week 0) and up to 108 weeks

  10. 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

    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.

    Measured: Baseline (Week 0) and up to 108 weeks

  11. 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

    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.

    Measured: Baseline (Week 0) and up to 112 weeks

  12. 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

    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.

    Measured: Baseline (Week 0) and up to 112 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2011 (estimated)
  2. Study start1 Apr 2011
  3. Primary completion1 Sep 2013
  4. Study completion29 Oct 2013

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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01318993
Sponsor's protocol ID
114644
Other IDs
2010-022384-35
Acronym
SHIELD-3
Status last verified
Jul 2017
First submitted
3 Mar 2011
Last updated
14 Sep 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK1605786A in people with Crohn's Disease, run by GlaxoSmithKline at 244 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 244 sites in United States, Canada, Japan, Israel, Spain and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE) (time frame: Up to Week 112). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01318993.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.

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