Open-Label Extension Study of GSK1605786A



Status:Completed
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:10/2/2013
Start Date:April 2011
End Date:July 2015
Contact:US GSK Clinical Call Center
Email:GSKClinicalSupportHD@gsk.com
Phone:877-379-3718

Use our guide to learn which trials are right for you!

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.


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.

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.
We found this trial at
26
sites
Bethesda, Maryland 20892
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
Anaheim, California 92807
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Aurora, Colorado 80010
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Baton Rouge, Louisiana 70809
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials
Chesterfield, Missouri 63017
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Durham, North Carolina 27705
?
mi
from
Durham, NC
Click here to add this to my saved trials
Glendale, Arizona 85304
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
Grand Rapids, Michigan 49546
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida 32207
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Joliet, Illinois 60435
?
mi
from
Joliet, IL
Click here to add this to my saved trials
Kennewick, Washington 99336
?
mi
from
Kennewick, WA
Click here to add this to my saved trials
Klamath Falls, Oregon 97601
?
mi
from
Klamath Falls, OR
Click here to add this to my saved trials
Knoxville, Tennessee 37916
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
La Crosse, Wisconsin 54601
?
mi
from
La Crosse, WI
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
New Haven, Connecticut 06520
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New York, New York 10032
?
mi
from
New York, NY
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Richmond, Virginia 23298
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Roswell, Georgia 30076
?
mi
from
Roswell, GA
Click here to add this to my saved trials
Salt Lake City, Utah 84132
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Weatherford, Oklahoma 73096
?
mi
from
Weatherford, OK
Click here to add this to my saved trials