A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 229

Inclusion Criteria

1. Subjects achieving clinical response (CDAI decrease = 100points) and/or remission
(CDAI <150) upon completion of treatment in Study CCX114151 or another GSK
sponsored induction study
2. Written informed consent prior to any CCX114157 specific study procedures
3. Females of child-bearing potential must be sexually inactive or commit to use of
consistent and correct use of contraceptive methods with a failure rate of < 1%, for
the duration of this 52 week study as defined by the following:
Abstinence
Sexual inactivity by abstinence must be consistent with the preferred and usual
lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Contraceptive Methods with a Failure Rate of < 1%
• Oral contraceptive, either combined or progestogen alone
• Injectable progestogen
• Implants of levonorgestrel
• Estrogenic vaginal ring
• Percutaneous contraceptive patches
• Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1%
failure rate as stated in the product label
• Male partner sterilisation (vasectomy with documentation of azoospermia)
prior to the female subject's entry into the study, and this male is the sole
partner for that subject. For this definition, documented” refers to the
outcome of the investigator's/designee’s medical examination of the subject
or review of the subject's medical history for study eligibility, as obtained via
a verbal interview with the subject or from the subject’s medical records.
• Double barrier method: condom and occlusive cap (diaphragm or
cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository)
These allowed methods of contraception are only effective when used consistently,
correctly and in accordance with the product label. The investigator is responsible for
ensuring subjects understand how to properly use these methods of contraception.
Female subjects should not be enrolled if they are pregnant or lactating or if they plan to become pregnant during the time of study participation. For women of childbearing potential, a urine pregnancy test will be performed on the morning of the randomisation visit and at repeated intervals throughout the study.
4. Any medications being currently received for Crohn’s disease must remain stable
throughout the study period with the exception of tapering of corticosteroids
5. Subjects on corticosteroids at entry must be willing to undergo corticosteroid dose
tapering
Note: Country-specific requirement for French subjects: In France, a subject will be
eligible for inclusion in this study only if either affiliated to or a beneficiary of a social
security category.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1

Exclusion Criteria

1. If female, is pregnant, has a positive pregnancy test or is breast-feeding
2. Subjects with known or suspected coeliac disease or a positive screening test (antitissue
transglutaminase antibodies) should have been excluded from enrolment into
the induction studies. Subjects in whom a diagnosis of coeliac disease is
subsequently suspected should have this excluded with testing for anti- tissue
transglutaminase antibodies prior to enrolment into the maintenance study.
3. Known or suspected small bowel stricture
4. Enterocutaneous , abdominal or pelvic fistulae likely to require surgery during the
study period
5. Current sepsis or infections requiring intravenous antibiotic therapy >2 weeks
6. Evidence of hepatic dysfunction, viral hepatitis, or liver function abnormalities:
Exhibits serum ALT (SGPT) and/or AST (SGOT) values =2 times the upper limit of
normal, or has a total bilirubin value =1.5 times the upper limit of normal: has
alkaline phosphatase = 1.5 times the upper limit of normal; has current or chronic
history of liver disease including non-alcoholic steatohepatitis (NASH) or known
hepatic or biliary abnormalities with the exception of Gilbert’s syndrome or
asymptomatic gallstones.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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