An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects With Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 399
- 试验地点
- 1
- 主要终点
- Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE)
研究概览
简要总结
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.
详细描述
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:
- 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
- completion of maintenance study CCX114157 at Week 52
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
GSK1605786A
500 milligrams twice daily
干预措施: GSK1605786A (Drug)
结局指标
主要结局
Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE)
时间窗: Up to Week 112
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. The Safety population consisted of all participants who enrolled in the study except those who did not take \>=1 dose of investigational product.
次要结局
- Change From Baseline (Week 0) in Systolic and Diastolic Blood Pressure (SBP and DBP) Over Period(Baseline (Week 0) and up to Week 112)
- Change From Baseline (Week 0) in Heart Rate (HR) Over Period(Baseline (week 0) and up to Week 112)
- Number of Participants With Shifts From Baseline (Week 0) for the Indicated Hematology Parameters(Baseline (Week 0) and up to Week 112)
- Number of Participants With Shifts From Baseline (Week 0) for the Indicated Clinical Chemistry Parameters(Baseline (Week 0) and up to Week 112)
- Change From Baseline (Week 0) in ALT, AST, ALP, and GGT as a Function of Liver Function Test (LFT)(Baseline (Week 0) and up to Week 112)
- Change From Baseline (Week 0) in Total Bilirubin(Baseline (Week 0) and up to Week 112)
- Change From Baseline (Week 0) in Albumin(Baseline (Week 0) and up to Week 112)
- Number of Participants With the Indicated Change From Baseline (Week 0) in Corrected QT Interval (QTc) Value(Baseline (week 0) and Weeks 24, 48, 72, 108, and 112 (4 weeks post treatment))
- Change From Baseline (Week 0) in Crohn's Disease Activity Index (CDAI) Score Over 108 Weeks(Baseline (Week 0) and up to 108 weeks)
- Percentage of Participants in Clinical Remission (CDAI Score Less Than 150) for All Participants, for Participants in Remission at Baseline (Week 0), and for Participants Not in Remission at Baseline Over 108 Weeks(Baseline (Week 0) and up to 108 weeks)
- Percentage of Participants Achieving Response (CDAI Decrease of at Least 100 Points From Baseline ([Week 0] of Prior Induction Study) in the Sub-population of Non-responders at Study Entry Over 112 Weeks(Baseline (Week 0) and up to 112 weeks)
- Change From Baseline (Week 0) in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form Health Survey (SF-36) Version 2, EuroQol 5 Dimensional (EQ-5D), Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and Disability Over 112 Weeks(Baseline (Week 0) and up to 112 weeks)