Crohn Disease Clinical Trial
Official title:
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)
The purpose of this study is to establish the incidence of sub-optimal response to anti-TNF therapy in UC and CD participants.
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.
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