EUCTR2010-022383-12-NL进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects achieving clinical response (CDAI decrease = 100points) and/or remission (CDAI <150) upon completion of treatment in Study CCX114151 or Study CCX114643
- •2. Written informed consent prior to any CCX114157 specific study procedures.
- •3.Females of child-bearing potential (FCBP) must be sexually inactive or commit to use of contraceptive methods with a failure rate of < 1% per year when used consistently and correctly and, when applicable, in accordance with the product label, for the duration of this study as defined by the following:
- •Contraceptive Methods with a Failure Rate of < 1%
- •Abstinence from penile-vaginal intercourse, when this is the female’s preferred and usual lifestyle
- •Oral contraceptive, either combined or progestogen alone
- •Injectable progestogen
- •Implants of etonogestrel or 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 sterilization prior to the female subject's entry into the study,
- •and this male is the sole partner for that subject. The information on the male
- •sterility can come from the site personnel’s: review of subject’s medical
- •records; medical examination of the subject and/or semen analysis; or interview with the subject on his medical history.
- •Male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository)
- •Male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or 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. This list does not apply to FCBP with same sex partners, when this is their preferred and usual lifestyle.
- •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 child-bearing potential, a urine pregnancy test will be performed at repeated intervals throughout the study and at the Early Withdrawal or Follow-up visits if applicable.
- •4. Any medications being currently received for Crohn’s disease must remain stable throughout the study period with the exception of tapering of corticosteroids and dose
- •reductions of immunosuppressants for the management of drug toxicity. See Study Procedures Manual.
- •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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 800
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •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 (anti-tTG) antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tTG antibodies and excluded or withdrawn from study upon positive result
- •3 Fixed symptomatic stenoses of small bowel or colon.
- •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. Use of prohibited medications at baseline and throughout the study (Section 5.5.3 of the protocol).
- •7. The subject exhibits evidence of hepatic dysfunction, viral hepatitis, or exhibits serum ALT (SGPT) and/or AST (SGOT) values =2 times the upper limit of normal; has a total bilirubin value >1.5 times the upper limit of normal (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%); has alkaline phosphatase >1.5 times the upper limit of normal; has current or chronic history of liver disease including non-alcoholic steatohepatitis (NASH); has known hepatic or biliary abnormalities with the exception of Gilbert’s syndrome or asymptomatic gallstones
- •Note: At randomisation into the study, liver function tests results from the final visit in the preceding induction study will not be available . Subjects who have abnormalities as per the exclusion above will need to be withdrawn.
研究者
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