Indicators of Sub-Optimal Response to Anti-Tumor Necrosis Factor (TNF) Therapy in Patients With Crohn's Disease (CD) and Ulcerative Colitis (UC): A Retrospective Chart Review in the Emerging Market (EM) Region (EXPLORE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,731
- 试验地点
- 76
- 主要终点
- Number of Participants With Each Type of Anti-TNF Therapy
研究概览
简要总结
The purpose of this study is to establish the incidence of sub-optimal response to anti-TNF therapy in UC and CD participants.
详细描述
Participants with historical diagnosis of CD and UC who were naïve to anti-TNF therapy were observed in this retrospective study. The study will look to identify the local barriers in prescribing anti-TNF therapy, treatment patterns and indicators of sub-optimal response to anti-TNF therapy in UC and CD participants in real-world clinical practice in the EM countries, along with the associated incidence of sub-optimal response and impact on health care resource utilization (HCRU). The will enroll approximately 2000 participants.
The study consists of two periods, eligibility period followed by a data abstraction period. During the eligibility period participants who had initiated first anti-TNF therapy during 01 March 2010 up to 01 March 2015 will be recruited and observed. Participants will be followed up for a period of minimum 2 years (other than death) and a maximum of 5 years from the date of first treatment of anti-TNF therapy for CD and UC (Index date). During the data abstraction period participants who have eligible medical charts will be identified and all retrospective data will be collected.
This multi-center trial will be conducted in Argentina, China, Colombia, Mexico, Russia, Saudi Arabia, Singapore, South Korea, Taiwan and Turkey. The overall time to abstract data during the data extraction period from the web-based electronic data capture (EDC) system will be approximately 1 year from March 2017 to February 2018.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Who are 18 years or older at Index Date and diagnosed with UC or CD.
- •Who were naive to anti-TNF therapy and received their first dose of any anti-TNF therapy (index date) for UC or CD within the Eligibility Period from 01 March 2010 through 01 March 2015.
排除标准
- •Diagnosed with indeterminate/unspecified type of IBD.
- •Were part of an IBD-related clinical trial during the observational period should be excluded (that is, index date up to the date of chart abstraction).
- •Who received an anti-TNF therapy for any non-UC or non-CD conditions (example, rheumatoid arthritis, ankylosing spondylitis, psoriasis, or cancer).
- •Who received an anti-TNF/biologic therapy at any point that was administered outside of the labelled dosing regimen (example, episodic use of anti-TNF therapy).
- •With UC who had a total colectomy prior to their first anti-TNF therapy.
- •Charts not available.
研究组 & 干预措施
All Participants
All participants with diagnosis of UC and CD, who initiated treatment with anti-TNF therapy from 01 March 2010 up to 01 March 2015 will be observed. Retrospective data extraction will be done for eligible participants from March 2017 up to approximately February 2018.
干预措施: Anti-TNF Therapy (Drug)
结局指标
主要结局
Number of Participants With Each Type of Anti-TNF Therapy
时间窗: 5 years
Number of Participants With Response to Treatment
时间窗: 5 years
Number of participants with response to treatment will be assessed.
Treatment Pattern Results Stratified by Anti-TNF Response Group and by UC or CD Diagnosis
时间窗: 5 years
Treatment patterns results were as per the Anti-TNF therapy response from UC and CD participants.
Time-to-switch
时间窗: 5 years
The time to switch at which the participant switched to another anti-TNF therapy will be evaluated.
Time-to-first Indicator of Sub-optimal Therapy
时间窗: 5 years
Time-to-first indicator of sub-optimal therapy was defined as the occurrence of dose escalation, therapy augmentation, therapy switch, therapy discontinuation, hospitalization, or surgery of participant, which ever occurred first.
Treatment Patterns in UC and CD Participants
时间窗: 5 years
Duration of Treatment
时间窗: 5 years
Incidence Rate of Sub-optimal Response in UC and CD Participants
时间窗: 5 years
Incidence rate will be calculated as the number of events divided by the total person time at risk, for participants under anti-TNF therapy.
次要结局
- Number of Participants With UC Achieving Clinical Response Based on Mayo Scores(Baseline up to 5 years)
- Number of Participants with Predictors of Sub-optimal Therapy in UC or CD Participants(Baseline up to 5 years)
- Number of Participants With CD Achieving Clinical Response Based on Harvey Bradshaw Index (HBI)(Baseline up to 5 years)
- Number of Participants with Inflammatory Bowel Disease (IBD) Related Surgeries and Hospitalisation(2 years prior to index anti-TNF therapy)
- Number of Participants with Co-morbidities(Baseline)
- Health Care Resources Utilisation (HCRU)(Baseline up to 7 years)
- Physician Survey Questionnaire(Baseline)