A Cluster Randomized Controlled Trial of an Enhanced Treatment Algorithm for the Management of Crohn's Disease - REACT2

Robarts Clinical Trials0 个研究点目标入组 1,200 人开始时间: 2014年12月15日最近更新: 2020年8月31日

适应症

试验速览

暂无简介。

•(1) Male or female patients 18 years or older.
•(2) Documented diagnosis of CD.
•(3) Written informed consent must be obtained and documented.
•(4) Willing to utilize study supply of adalimumab, if indicated according to treatment algorithm.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 900
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 300

•(1) Any conditions (e.g., history of alcohol or substance abuse, or lack of compliance) which, in the opinion of the investigator, may interfere with the patient's ability to comply with study procedures.
•(2) Latex allergy or other conditions in which adalimumab syringes are contraindicated, or any conditions in which adalimumab/TNF antagonist treatment is contraindicated.
•(3) Currently participating, or planning to participate in a study involving investigational product within 24 months that may interfere with the patient's ability to comply with study procedures.
•(4) Previously failed all classes of TNF antagonists for the treatment of CD.
•(5) Diagnosis of short bowel syndrome.
•(6) Current diagnosis of tuberculosis (TB) (active or latent), active or chronic hepatitis B.

发起方

Robarts Clinical Trials