AzTrials
AzTrials

Crohn's DiseasePhase 3SHIELD-1NCT01277666

A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease

A Phase 3 study testing GSK1605786A in people with Crohn's Disease, run by GlaxoSmithKline at 219 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is 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 as compared to placebo over 12 weeks in adult subjects with moderately-to-severely active Crohn's disease. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
608 participants
Where
219 sitesin 23 countries
Study dates
20 Dec 2010to 11 Jul 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

  • Male or female subjects aged 18 years or older
  • Written informed consent
  • Diagnosis of Crohn's disease for greater than 4 months duration with small bowel and/or colonic involvement
  • Confirmation of Crohn's disease established by visualisation of the gastrointestinal tract within the 12 months prior to screening or by screening endoscopy at study entry
  • History of inadequate response and/or intolerance/adverse event leading to discontinuation of either corticosteroids or immunosuppressants
  • Moderately-to-severely active disease characterised by a CDAI score between 220 and 450, inclusive, at Baseline
Show all 10Show fewer
  • Confirmation of current active Crohn's disease by screening endoscopy or inflammatory biomarkers [elevated C-reactive protein (greater than upper limit of normal) plus positive test for faecal calprotectin] at Screening
  • Stable doses of permitted concomitant medications or having previously received, but are not currently receiving, medications for Crohn's disease
  • Demonstrated ability to comply with Crohn's disease symptom recording using the interactive voice response system
  • Females of child-bearing potential must be sexually inactive or commit to consistent and correct use of a contraceptive method of birth control with a failure rate of less than 1% for the duration of this study

Who cannot join

  • If female: pregnant, has a positive pregnancy test or is breast-feeding
  • Diagnosis of coeliac disease, follow a gluten-free diet to manage symptoms, or positive test for coeliac disease
  • Diagnosis of ulcerative or indeterminate colitis
  • Enterocutaneous, abdominal or pelvic fistulae with abscesses or fistulae likely to require surgery during the study period
  • Bowel surgery, other than appendectomy, within 12 weeks prior to screen and/or has surgery planned or deemed likely for Crohn's disease during the study period
  • Extensive colonic resection, subtotal or total colectomy
Show all 34Show fewer
  • Presence of ileostomies, colostomies or rectal pouches
  • Known fixed symptomatic stenoses
  • History of more than 3 small bowel resections or diagnosis of short bowel syndrome
  • Chronic use of narcotics for chronic pain defined as daily use of one or more doses of narcotic containing medication
  • Use of prohibited medications, including enteral feeding or elemental diet, within their specified time frames
  • Biologic use: Use of any biologic (tumour necrosis factor inhibitor or natalizumab) within 8 weeks prior to screening
  • Corticosteroid use: Use of parenteral glucocorticoids within 4 weeks prior to screening
  • Immunospressant use: Use of cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil within 4 weeks prior to screening
  • Intravenous antibiotic use: Use of intravenous antibiotics for Crohn's disease within 4 weeks prior to screening
  • Use of rectal treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks prior to screening
  • Use of tube or enteral feeding, elemental diet, or parenteral alimentation within 2 weeks prior to screening
  • Leukocytapheresis or granulocytapheresis within 2 weeks prior to screening
  • Positive immunoassay for Clostridium difficile
  • Known human immunodeficiency virus (HIV) infection
  • Known varicella, herpes zoster, or other severe viral infection within 6 weeks of screening
  • Immunisation with a live vaccine within 4 weeks of screening, with the exception of influenza vaccine
  • Active or latent tuberculosis infection
  • Current sepsis or infections requiring intravenous antibiotic therapy for more than 2 weeks
  • Evidence of hepatic dysfunction, viral hepatitis, or current or chronic history of liver disease including non-alcoholic steatohepatitis (NASH)
  • Positive test for Hepatitis B or Hepatitis C antibody at screening
  • Corrected QT interval of ECG (electrocardiogram) greater than or equal to 450 milliseconds
  • Concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study
  • History or evidence of adenomatous colonic polyps that have not been removed
  • History of evidence of colonic mucosal dysplasia
  • Current evidence of, or has been treated for a malignancy within the past five years (other than localised basal cell, squamous cell skin cancer, cervical dysplasia, or any cancer in situ that has been resected)
  • Any previous participation in a clinical study of GSK1605786A (formerly ChemoCentryx compound CCX282-B)
  • Medical history of sensitivity to any of the components of GSK1605786A
  • Use of any investigational product within 30 days prior to screening

Trial locations and contacts

219 sites in 23 countries.

219 sites in 23 countries

United States48 sites

  • GSK Investigational Site

    Anaheim, California, 92801

  • GSK Investigational Site

    Ann Arbor, Michigan, 48109-5048

  • GSK Investigational Site

    Atlanta, Georgia, 30342-5006

  • GSK Investigational Site

    Austin, Texas, 78745

  • GSK Investigational Site

    Boston, Massachusetts, 02114

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599

  • GSK Investigational Site

    Chesterfield, Michigan, 48047

  • GSK Investigational Site

    Chevy Chase, Maryland, 20815

  • GSK Investigational Site

    Chicago, Illinois, 60637

  • GSK Investigational Site

    Columbus, Ohio, 43215

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    Egg Harbor City, New Jersey, 08234

  • 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

    Houston, Texas, 77034-0550

  • GSK Investigational Site

    Indianapolis, Indiana, 46237

  • GSK Investigational Site

    Jackson, Mississippi, 39202

  • GSK Investigational Site

    Jacksonville, Florida, 32207

  • GSK Investigational Site

    Jacksonville, Florida, 32256-6004

  • GSK Investigational Site

    Lakewood, Colorado, 80215

  • GSK Investigational Site

    Lebanon, New Hampshire, 03756

  • 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

    Los Angeles, California, 90015

  • GSK Investigational Site

    Maitland, Florida, 32751

  • GSK Investigational Site

    Monroe, Louisiana, 71201

  • GSK Investigational Site

    Nashville, Tennessee, 37212-1610

  • GSK Investigational Site

    Oak Lawn, Illinois, 60453

  • GSK Investigational Site

    Pasadena, Texas, 77505

  • GSK Investigational Site

    Port Orange, Florida, 32127

  • GSK Investigational Site

    Portland, Oregon, 97225

  • GSK Investigational Site

    Raleigh, North Carolina, 27612

  • GSK Investigational Site

    Rochester, Minnesota, 55905

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • 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

    Towson, Maryland, 21204

  • GSK Investigational Site

    Troy, Michigan, 48098

  • GSK Investigational Site

    Tucson, Arizona, 85712

  • GSK Investigational Site

    Tulsa, Oklahoma, 74135

  • GSK Investigational Site

    Tupelo, Mississippi, 38801

  • GSK Investigational Site

    Voorhees Township, New Jersey, 08043

Other trials in United States

Canada20 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 4A6

  • GSK Investigational Site

    Hamilton, Ontario, L8S 4K1

  • GSK Investigational Site

    Kingston, Ontario, K7L 5G2

  • GSK Investigational Site

    Lévis, Quebec, G6V 3Z1

  • 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

    Richmond Hill, Ontario, L4B 3P8

  • GSK Investigational Site

    Toronto, Ontario, M5G 1X5

  • GSK Investigational Site

    Vancouver, British Columbia, V6Z 2K5

  • GSK Investigational Site

    Victoria, British Columbia, V8V 3M9

  • GSK Investigational Site

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Germany19 sites

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 12157

  • GSK Investigational Site

    Berlin, 13353

  • GSK Investigational Site

    Braunschweig, Lower Saxony, 38126

  • GSK Investigational Site

    Brinkum/Stuhr, Lower Saxony, 28816

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50937

  • GSK Investigational Site

    Dessau, Saxony-Anhalt, 06847

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60590

  • GSK Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • GSK Investigational Site

    Halle, Saxony-Anhalt, 06120

  • GSK Investigational Site

    Hamburg, 20148

  • GSK Investigational Site

    Hamburg, 22559

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

  • GSK Investigational Site

    Jena, Thuringia, 07747

  • GSK Investigational Site

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67067

  • GSK Investigational Site

    Minden, North Rhine-Westphalia, 32423

  • GSK Investigational Site

    Münster, North Rhine-Westphalia, 48149

  • GSK Investigational Site

    Münster, North Rhine-Westphalia, 48159

  • GSK Investigational Site

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Japan15 sites

  • GSK Investigational Site

    Aichi, 460-0012

  • GSK Investigational Site

    Aichi, 466-8560

  • GSK Investigational Site

    Chiba, 285-8741

  • GSK Investigational Site

    Fukuoka, 812-8582

  • GSK Investigational Site

    Fukuoka, 818-8502

  • 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, 113-8519

  • GSK Investigational Site

    Tokyo, 160-8582

  • GSK Investigational Site

    Tokyo, 169-0073

Other trials in Japan

France9 sites

  • GSK Investigational Site

    Amiens, 80054

  • 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

United Kingdom9 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

    Nottingham, NG7 2UH

  • GSK Investigational Site

    Oxford, OX3 9DU

  • GSK Investigational Site

    Salford, M6 8HD

Other trials in United Kingdom

Belgium8 sites

  • GSK Investigational Site

    Bonheiden, 2820

  • GSK Investigational Site

    Brussels, 1000

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Edegem, 2650

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Kortrijk, 8500

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Roeselare, 8800

Other trials in Belgium

Czechia8 sites

  • GSK Investigational Site

    Brno, 625 00

  • 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

Australia7 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Bankstown, New South Wales, 2200

  • 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

Israel7 sites

  • 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

    Tel Aviv, 64239

Other trials in Israel

Poland7 sites

  • GSK Investigational Site

    Bydgoszcz, 85-168

  • GSK Investigational Site

    Bydgoszcz, 85-681

  • GSK Investigational Site

    Elblag, 82-300

  • 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

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

Netherlands6 sites

  • GSK Investigational Site

    Almere Stad, 1315 RA

  • GSK Investigational Site

    Amsterdam, 1091 AC

  • GSK Investigational Site

    Amsterdam, 1105 AZ

  • GSK Investigational Site

    Ede, 6716 RP

  • GSK Investigational Site

    Heerlen, 6419 PC

  • GSK Investigational Site

    Rotterdam, 3015 CE

Other trials in Netherlands

New Zealand6 sites

  • GSK Investigational Site

    Auckland, 1148

  • GSK Investigational Site

    Dunedin, 9054

  • GSK Investigational Site

    Hamilton, 3204

  • GSK Investigational Site

    Lower Hutt, 6007

  • GSK Investigational Site

    Otahuhu, 1640

  • GSK Investigational Site

    Tauranga, 3143

Other trials in New Zealand

Norway6 sites

  • GSK Investigational Site

    Ålesund, 6017

  • GSK Investigational Site

    Bodø, 8005

  • GSK Investigational Site

    Oslo, N-0456

  • GSK Investigational Site

    Tønsberg, 3116

  • GSK Investigational Site

    Tromsø, 9038

  • GSK Investigational Site

    Trondheim, 7030

Other trials in Norway

South Korea6 sites

  • GSK Investigational Site

    Daegu, 705-717

  • GSK Investigational Site

    Pusan, 602-739

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul, 130-702

  • GSK Investigational Site

    Seoul, 135-230

  • GSK Investigational Site

    Wŏnju, 220701

Other trials in South Korea

Denmark5 sites

  • GSK Investigational Site

    Aalborg, 9000

  • GSK Investigational Site

    Aarhus, 8000

  • GSK Investigational Site

    Herlev, 2730

  • GSK Investigational Site

    Hvidovre, 2650

  • GSK Investigational Site

    Odense, 5000

Other trials in Denmark

Italy5 sites

  • GSK Investigational Site

    Genova, 16132

  • GSK Investigational Site

    Modena, 41100

  • GSK Investigational Site

    Palermo, Sicily, 90127

  • GSK Investigational Site

    Roma, 00152

  • GSK Investigational Site

    Roma, 00168

Other trials in Italy

Spain5 sites

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Elche, 03293

  • GSK Investigational Site

    Galdakao/Vizcaya, 48960

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Sabadell (Barcelona), 08208

Other trials in Spain

Sweden5 sites

  • GSK Investigational Site

    Gothenburg, SE-416 85

  • GSK Investigational Site

    Lund, SE-221 85

  • GSK Investigational Site

    Stockholm, SE-171 76

  • GSK Investigational Site

    Stockholm, SE-182 88

  • GSK Investigational Site

    Umeå, SE-901 85

Other trials in Sweden

Austria4 sites

  • GSK Investigational Site

    Hall in Tirol, 6060

  • GSK Investigational Site

    Linz, A-4021

  • GSK Investigational Site

    Vienna, 1050

  • GSK Investigational Site

    Vienna, 1090

Other trials in Austria

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

Hungary3 sites

  • GSK Investigational Site

    Békéscsaba, 5600

  • GSK Investigational Site

    Budapest, 1088

  • GSK Investigational Site

    Szekszárd, 7100

Other trials in Hungary

About this study

Official title: A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease

This is 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 as compared to placebo over 12 weeks in adult subjects with moderately-to-severely active Crohn's disease. Efficacy will be assessed by proportion of subjects achieving response, defined as a decrease in Crohn's Disease Activity Index (CDAI) score of at least 100 points (clinical response). Clinical remission (CDAI score less than 150 points) will be evaluated as a key secondary endpoint. Safety will be assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram (ECG). Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form-36 version 2 (SF-36v2), EQ-5D and Work Productivity and Activity Impairment-CD (WPAI-CD) and receipt of disability.

Read the detailed description

This is a multi-centre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the efficacy of two oral doses of GSK1605786A (500 mg once daily, 500 mg twice daily) as compared to placebo in the induction of clinical response over a 12-week treatment period in subjects with moderately-to-severely active Crohn's disease. Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of remission.

The study is planned to randomise approximately 600 subjects (200 subjects/group) with active Crohn's disease, diagnosed for at least 4 months with a documented history of disease in the small and/or large intestine, and characterised by a Crohn's Disease Activity Index (CDAI) score between 220 to and 450, inclusive. Subjects must have reported an inadequate response or intolerance to Crohn's disease treatment with corticosteroids or immunosuppressants. Inclusion of subjects who received prior treatment with a biologic anti-tumour necrosis factor (TNF) agent will be limited to approximately 50% of the study population. All subjects are required to have a diagnosis with identification of anatomic location of Crohn's disease, which has been established by visualisation of the gastrointestinal tract within 12 months of screening. Subjects who have not had a visualisation of the gastrointestinal tract within 12 months are required to undergo an endoscopic assessment during the screening period. Subjects will be required to have evidence of current active inflammation at the time of randomisation either by endoscopy or by inflammatory biomarkers [elevated C-reactive protein (CRP) greater than the upper limit of normal (ULN) plus a positive faecal calprotectin test]. Subjects who do not meet the requirements based on inflammatory biomarker test results will be required to qualify based on endoscopic assessment during screening. Subjects will be allowed to participate in the study while continuing on stable doses of agents typically used to treat Crohn's disease. Following the screening period, subjects will be randomised at baseline to receive blinded treatment with one of two doses of GSK1605786A (500 mg once daily or twice daily) or placebo for 12 weeks. Response and remission endpoints, using the CDAI, will be evaluated at Weeks 4, 8 and 12.

Conditions
Crohn's Disease
Being tested
GSK1605786A, Placebo
Keywords
Crohn's disease, capsule, GSK1605786A, quality of life, inflammatory bowel disease, oral therapy
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 mg twice daily, administered orally for 12 weeks

  • GSK1605786ADrug

    500 mg once daily, administered orally for 12 weeks

  • PlaceboDrug

    Placebo capsules, administered orally for 12 weeks

Study groups in NCT01277666
Study groupRoleWhat they receive
PlaceboPlacebo comparatororally administered
Receives: Drug: Placebo
GSK1605786A 500mg once dailyExperimentalorally administered
Receives: Drug: GSK1605786A
GSK1605786A 500mg twice dailyExperimentalorally administered
Receives: Drug: GSK1605786A

What is being measured

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

  1. Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 12

    CDAI is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. The score was algorithmically derived from the sum of participant reported Crohn's disease symptoms recorded over 7 days and investigator recorded assessments of the participant's condition, laboratory parameters and use of anti-diarrhoeal medication. CDAI score was calculated based on the data collected in the diary card. The total CDAI score ranged from 0 to approximately 600, where higher scores indicate more severe disease. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of participants with CDAI response at Week 12 was presented.

    Measured: Week 12

Secondary outcomes (7)

  1. Percentage of Participants With CDAI Remission at Week 12

    CDAI is a recognized scoring system to categorize disease severity with scores of >= 220 to <= 450 describing the moderately-to-severely active population. Clinical remission is defined as a CDAI score < 150 points if baseline CDAI is >= 150. If baseline CDAI is <150, the participant was not considered in remission. Participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants in clinical remission at Week 12 was presented.

    Measured: Week 12

  2. Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >= 100 Points) at Both Week 8 and Week 12

    Responders were defined as participants with CDAI decrease from baseline of >= 100 points. CDAI is a recognized scoring system to categorize disease severity with scores of >= 220 to <= 450 describing the moderately-to-severely active population. The score was algorithmically derived from the sum of participant reported Crohn's disease symptoms recorded over 7 days and investigator recorded assessments of the participant's condition, laboratory parameters and use of anti-diarrhoeal medication. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of participants with CDAI decrease from baseline of >=100 points was presented.

    Measured: At Week 8 and 12

  3. Percentage of Participants Achieving Clinical Remission (CDAI <150 Points) at Both Week 8 and Week 12

    Clinical remission is defined as a CDAI score < 150 points if baseline CDAI is >= 150. If baseline CDAI is <150, the participant was not considered in remission. participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants in clinical remission defined as a CDAI score of less than 150 points at other time points was presented.

    Measured: Week 8 and 12

  4. Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >=100 Points) at Week 8

    CDAI is a recognized scoring system to categorize disease severity with scores of >= 220 to <= 450 describing the moderately-to-severely active population. The score was algorithmically derived from the sum of participant reported Crohn's disease symptoms recorded over 7 days and investigator recorded assessments of the participant's condition, laboratory parameters and use of anti-diarrhoeal medication. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of Participants with a clinical response CDAI decrease from baseline of >=100 points at Week 8 was presented.

    Measured: Week 8

  5. Percentage of Participant Achieving Clinical Remission (CDAI <150 Points) at Week 8

    Clinical remission is defined as a CDAI score < 150 points if baseline CDAI is >= 150. If baseline CDAI is <150, the participant was not considered in remission. participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants achieving clinical remission with CDAI <150 points at Week 8 was presented.

    Measured: Week 8

  6. Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Both Weeks 8 and 12

    The IBDQ is a 32-item IBD-specific health related quality of life instrument evaluating general activities of daily living, intestinal function, social performance, personal interactions, and emotional status. Each item response was graded from 1 to 7 for each area evaluated. A higher score indicated better function in that area. Total IBDQ score was obtained by summing up scores for all 32 questions. Total IBDQ score ranged from 32 to 224. A higher score indicated better quality of life and lower score indicated worse quality of life. Day 1 assessment was considered as Baseline. Change from Baseline was calculated by subtracting value at Baseline from value at Weeks 8 and 12.

    Measured: Baseline (Week 0), Week 8 and Week 12

  7. Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)

    Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.

    Measured: Up to Week 12

Timeline

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

  1. First posted17 Jan 2011 (estimated)
  2. Study start20 Dec 2010
  3. Primary completion11 Jul 2013
  4. Study completion11 Jul 2013

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
608 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01277666
Sponsor's protocol ID
114151
Acronym
SHIELD-1
Status last verified
Jul 2017
First submitted
13 Jan 2011
Last updated
19 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 219 sites in 23 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 10 inclusion and 34 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: finished, as of the sponsor's last update on 19 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 219 sites in United States, Canada, Germany, Japan, France and 18 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. Some participants in this study may receive a placebo. 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 19 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?

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 12 (time frame: Week 12). 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 NCT01277666.

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 19 Sep 2017.

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