A Randomized Evaluation of Health Costs and Resource Utilization Comparing Testing-Based Therapy to Empiric Dose Intensification for the Management of Inflammatory Bowel Disease.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- the mean difference in cumulative costs (Visit I to Week 3 1) between the two treatment arms
研究概览
简要总结
Utilization of health resources in a testing based strategy versus an empiric dose escalation strategy to manage Crohn's disease and Ulcerative Colitis in subjects with loss of response to infliximab or adalimumab.
详细描述
The purpose of this study is to evaluate the utilization of health resources in a testing based strategy versus an empiric dose escalation strategy to manage Crohn's disease and Ulcerative Colitis in subjects with loss of response to infliximab or adalimumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
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
- •Males 18 years of age or older who are not receiving azathioprine or 6 mercaptopurine.
- •Non-pregnant, non-lactating females, 18 years of age or older.
- •Females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. [defined as a minimum of one year since the last menstrual period]).
- •Documented diagnosis of CD or UC.
- •Active disease symptoms at visit 1 defined by: a. CD subjects: HBS ~ 6 UC subjects: PMCS ~
- •Current infliximab therapy (naive to adalimumab) or current adalimumab therapy (naive to infliximab ).
- •A minimum of 13 weeks of infliximab or adalimumab treatment prior to visit 1 at the following dose:
- •Stable dose of azathioprine, 6 mercaptopurine, methotrexate, and/or 5-aminosalicylates in the 4 weeks prior to visit 1.
排除标准
- •Contraindication to the use of either infliximab or adalimumab.
- •Current infliximab treatment but not naive to adalimumab or
- •Current adalimumab treatment but not naive to infliximab.
- •Infliximab dosing prior to visit 1 was not 5 mg/kg at weeks 0, 2 and 6 and then q8w.
- •Adalimumab dosing prior to visit 1 was not 160 mg at week 0, 80 mg at week 2, and then 40 mg q2w.
- •Received any investigational drug within 30 days prior to visit
- •Serious underlying disease other than CD or UC which in the opinion of the investigator may interfere with the subject's ability to participate fully in the study.
- •History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures.
- •Stools positive for clostridium difficile.
- •Pregnant or lactating women.
- •Change in dose of azathioprine, 6 mercaptopurine, methotrexate, and/or 5-aminosalicylates in the 4 weeks prior to visit
- •Males 22 years of age or less who are receiving azathioprine or 6 mercaptopurine.
研究组 & 干预措施
Empiric Dose Intensification
Intensify treatment with the existing drug
干预措施: Intensify treatment with the existing drug (Other)
Testing based strategy
Measurement of drug (Adalimumab/Infliximab) Testing-based strategy for the management of secondary loss of response that is based on drug/ ADA measurement
干预措施: Measurement of drug (Adalimumab/Infliximab) (Other)
结局指标
主要结局
the mean difference in cumulative costs (Visit I to Week 3 1) between the two treatment arms
时间窗: 31 weeks
Analysis of costs and outcomes will be made on an intention-to-treat basis
次要结局
- The efficacy of the testing-based strategy compared to empiric dose intensification(31 weeks)