Adherence of a 1.600 mg single tablet 5-ASA treatment of Ulcerative colitis (EASI-trial)

Copenhagen University Hospital Hvidovre0 个研究点目标入组 200 人开始时间: 2019年6月24日最近更新: 2020年7月27日

适应症

试验速览

暂无简介。

•Signed informed consent
•Age between 18 and 60
•Diagnosed with UC according to the Copenhagen Diagnostic Criteria
•Length of disease of max. 10 years
•Stable remission on 5-ASA (defined as partial Mayo score =1) for at least 2 months without need for oral corticosteroids.
•Endoscopic remission defined as Mayo Clinic Endoscopic Score < 2
•Have had a relapse within the last 2 years
•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 200
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Evidence of infectious diarrhoea (i.e. pathogenic viruses, bacteria or Clostridium difficile toxin in stool culture) within the last month
•On immunomodulators, including methotrexate
•On any biological therapy
•Any previous abdominal surgery related to UC
•Any chronic infections (e.g. HBV, HCV, HIV)
•Any severe concomitant cardiovascular, autoimmune, hematologic, hepatic, renal, endocrine, oncologic or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient’s compliance or the interpretation of the results
•Well-founded doubt about the patient’s cooperation, e.g., because of addiction to alcohol or drugs
•Participation in another clinical trial within the last 30 days, or simultaneous participation in another clinical trial.

发起方

Copenhagen University Hospital Hvidovre