Open-Label Extension Study of GSK1605786A

Crohn's Disease Clinical Trial

— SHIELD-3  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01318993
• Other study ID #: 114644
• Secondary ID: 2010-022384-35
• Status: Terminated
• Phase: Phase 3
• First received: March 3, 2011
• Last updated: March 13, 2014
• Start date: April 2011
• Est. completion date: September 2013

Study information

• Verified date: March 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines AgencyAustralia: Human Research Ethics CommitteeBelgium: Federal Agency for Medicines and Health Products, FAMHPUnited States: Food and Drug AdministrationCanada: Health CanadaDenmark: Danish Medicines AgencyJapan: Pharmaceuticals and Medical Devices AgencySweden: Medical Products Agency
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• GSK1605786A
500 milligrams twice daily

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Adelaide	South Australia
Australia	GSK Investigational Site	Bankstown	New South Wales
Australia	GSK Investigational Site	Box Hill	Victoria
Australia	GSK Investigational Site	Fitzroy	Victoria
Australia	GSK Investigational Site	Fremantle	Western Australia
Australia	GSK Investigational Site	Hersten	Queensland
Australia	GSK Investigational Site	Kurralta Park	South Australia
Australia	GSK Investigational Site	Prahran	Victoria
Austria	GSK Investigational Site	Hall in Tirol
Austria	GSK Investigational Site	Linz
Austria	GSK Investigational Site	Oberpullendorf
Austria	GSK Investigational Site	St.Veit/Glan
Austria	GSK Investigational Site	Wien
Austria	GSK Investigational Site	Wien
Austria	GSK Investigational Site	Wien
Belgium	GSK Investigational Site	Bonheiden
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Kortrijk
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Roeselare
Bulgaria	GSK Investigational Site	Plovdiv
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Varna
Canada	GSK Investigational Site	Abbotsford	British Columbia
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	Kingston	Ontario
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Winnipeg	Manitoba
Chile	GSK Investigational Site	Vina del Mar
Czech Republic	GSK Investigational Site	Hradec Králové
Czech Republic	GSK Investigational Site	Olomouc
Czech Republic	GSK Investigational Site	Ostrava - Vitkovice
Czech Republic	GSK Investigational Site	Praha 10
Czech Republic	GSK Investigational Site	Praha 4
Czech Republic	GSK Investigational Site	Praha 7
Czech Republic	GSK Investigational Site	Praha 9
Denmark	GSK Investigational Site	Aalborg
Denmark	GSK Investigational Site	Aarhus
Denmark	GSK Investigational Site	Herlev
Denmark	GSK Investigational Site	Hvidovre
Denmark	GSK Investigational Site	Odense
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
France	GSK Investigational Site	Clichy cedex
France	GSK Investigational Site	Lille cedex
France	GSK Investigational Site	Nantes cedex 1
France	GSK Investigational Site	Nice cedex 3
France	GSK Investigational Site	Paris cedex 10
France	GSK Investigational Site	Pessac cedex
France	GSK Investigational Site	Saint-Priest en Jarez
France	GSK Investigational Site	Vandoeuvre Les Nancy
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Frankfurt am Main	Hessen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Minden	Nordrhein-Westfalen
Germany	GSK Investigational Site	Ulm	Baden-Wuerttemberg
Hong Kong	GSK Investigational Site	Hong Kong
Hong Kong	GSK Investigational Site	Shatin, New Territories
Hungary	GSK Investigational Site	Bekescsaba
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Debrecen
Hungary	GSK Investigational Site	Mosonmagyaróvár
Hungary	GSK Investigational Site	Szekszárd
Hungary	GSK Investigational Site	Vác
Israel	GSK Investigational Site	Afula
Israel	GSK Investigational Site	Beer Sheva
Israel	GSK Investigational Site	Haifa
Israel	GSK Investigational Site	Holon
Israel	GSK Investigational Site	Jerusalem
Israel	GSK Investigational Site	Jerusalem
Israel	GSK Investigational Site	Kfar Saba
Israel	GSK Investigational Site	Petah Tikva
Israel	GSK Investigational Site	Ramat-Gan
Israel	GSK Investigational Site	Tel Aviv
Israel	GSK Investigational Site	Zerifin
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Modena
Italy	GSK Investigational Site	Palermo	Sicilia
Italy	GSK Investigational Site	Roma
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Chiba
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Hiroshima
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hyogo
Japan	GSK Investigational Site	Kagoshima
Japan	GSK Investigational Site	Kagoshima
Japan	GSK Investigational Site	Miyagi
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Korea, Republic of	GSK Investigational Site	Busan
Korea, Republic of	GSK Investigational Site	Daegu
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Wonju
New Zealand	GSK Investigational Site	Dunedin
New Zealand	GSK Investigational Site	Lower Hutt
New Zealand	GSK Investigational Site	Otahuhu, Auckland
New Zealand	GSK Investigational Site	Tauranga.
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Sopot
Poland	GSK Investigational Site	Torun
Poland	GSK Investigational Site	Wroclaw
Portugal	GSK Investigational Site	Lisboa
Portugal	GSK Investigational Site	Lisboa
Portugal	GSK Investigational Site	Porto
Portugal	GSK Investigational Site	Viseu
Russian Federation	GSK Investigational Site	Kazan
Russian Federation	GSK Investigational Site	Lipetsk
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Nizhniy Novgorod
Russian Federation	GSK Investigational Site	Rostov-on-Don
Russian Federation	GSK Investigational Site	Samara
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	Tomsk
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Nitra
Slovakia	GSK Investigational Site	Nove Mesto nad Vahom
Slovakia	GSK Investigational Site	Presov
Slovakia	GSK Investigational Site	Trnava
South Africa	GSK Investigational Site	Bellville
South Africa	GSK Investigational Site	Claremont
South Africa	GSK Investigational Site	Observatory
South Africa	GSK Investigational Site	Parktown
Spain	GSK Investigational Site	Badalona
Spain	GSK Investigational Site	Elche
Spain	GSK Investigational Site	Fuenlabrada (Madrid)
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Marbella
Spain	GSK Investigational Site	Sabadell (Barcelona)
Spain	GSK Investigational Site	Santander
Sweden	GSK Investigational Site	Lund
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Stockholm
Switzerland	GSK Investigational Site	Bern
Switzerland	GSK Investigational Site	Zürich
Taiwan	GSK Investigational Site	Taichung
Turkey	GSK Investigational Site	Ankara
Ukraine	GSK Investigational Site	Chernivtsi
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Donetsk
Ukraine	GSK Investigational Site	Donetsk
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Odesa
Ukraine	GSK Investigational Site	Simferopol
Ukraine	GSK Investigational Site	Vinnytsya
United Kingdom	GSK Investigational Site	Birmingham
United Kingdom	GSK Investigational Site	Bristol
United Kingdom	GSK Investigational Site	Edinburgh
United Kingdom	GSK Investigational Site	Harrow	Middlesex
United Kingdom	GSK Investigational Site	Manchester
United Kingdom	GSK Investigational Site	Newcastle-upon-Tyne
United Kingdom	GSK Investigational Site	Oxford
United Kingdom	GSK Investigational Site	Salford
United States	GSK Investigational Site	Anaheim	California
United States	GSK Investigational Site	Ann Arbor	Michigan
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Aurora	Colorado
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Brooklyn	New York
United States	GSK Investigational Site	Chapel Hill	North Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Chesterfield	Michigan
United States	GSK Investigational Site	Chevy Chase	Maryland
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Christiansburg	Virginia
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Danville	Virginia
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	East Setauket	New York
United States	GSK Investigational Site	Germantown	Tennessee
United States	GSK Investigational Site	Great Neck	New York
United States	GSK Investigational Site	Hamden	Connecticut
United States	GSK Investigational Site	Hammond	Louisiana
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	La Jolla	California
United States	GSK Investigational Site	Lake Success	New York
United States	GSK Investigational Site	Lakewood	Colorado
United States	GSK Investigational Site	Lee's Summit	Missouri
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Little Rock	Arizona
United States	GSK Investigational Site	Littleton	Colorado
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Mexico	Missouri
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Monroe	Louisiana
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New Haven	Connecticut
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Ogden	Utah
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Port Orange	Florida
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Rochester	Minnesota
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	South Towson	Maryland
United States	GSK Investigational Site	Suwanee	Georgia
United States	GSK Investigational Site	Towson	Maryland
United States	GSK Investigational Site	Troy	Michigan
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tulsa	Oklahoma
United States	GSK Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Chile,  Czech Republic,  Denmark,  Estonia,  France,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  New Zealand,  Poland,  Portugal,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events and serious adverse events	Incidence of adverse events and serious adverse events	Over 112 weeks	No
Secondary	Change from baseline in vital signs, haematology and clinical chemistry parameters, electrocardiogram measurements	Change from baseline in vital signs, haematology and clinical chemistry, electrocardiogram measurements	Over 112 weeks	No
Secondary	Change from baseline in CDAI score	Change from baseline in CDAI score	Over 112 weeks	No
Secondary	Proportion of subjects in clinicalremission	Proportion of subjects in clinical remission (CDAI score less than 150) for all subjects, for subjects in remission at baseline and for subjects not in remission at baseline	Over 112 weeks	No
Secondary	Proportion of subjects achieving clinical response	Proportion of subjects achieving response (CDAI decrease of at least 100 points from baseline of prior induction study) in the sub-population of non-responders at study entry	Over 112 weeks	No
Secondary	Change from baseline in health outcome measures (IBDQ, SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's disease and disability)	Change from baseline in IBDQ, SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and disability	Over 112 weeks	No