A randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate - CASA trial

niversity of Nottingham0 个研究点目标入组 420 人开始时间: 2005年8月17日最近更新: 2019年6月30日

适应症

试验速览

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•1) Male and female patients aged between 18 and 75 years with ulcerative colitis.
•2) Patients whose ulcerative colitis has been in clinical remission, defined as, being off steroids for 3 months or longer.
•3) Patients taking both azathioprine (or 6 mercaptopurine) and an aminosalicylate.
•4) Patients taking azathioprine (>50mg/day) OR 6-mercaptopurine (>25mg/day) at a stable dose for at least 8 weeks.
•5) Patients taking an aminosalicylate at a stable dose (specified below) for at least 4 weeks: sulphasalazine >1.5g/day, Pentasa (slow release mesalazine) >750mg/day, Asacol (mesalazine)or generic equivalents >800mg/day, Colazide (balsalazide) >2.25g/day, Dipentum (olsalazine) >750mg/day
•6) Patients on combined treatment with azathioprine (or 6-MP) and an aminosalicylate for a minimum of 6 months but no more than 4 years. Patients may enter if they have briefly been off either treatment during this time (eg because of abnormal blood test results) but prescription of each drug should cover at least 85% of the period of time for continuous drug treatment to be declared. NB Duration of aminosalicylate may be longer.
•7) Patients who have given written informed consent.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1) Patients with Crohn’s disease.
•2) Patients with a baseline Walmsley Simple Activity Index >2.
•3) Patients with a baseline sigmoidoscopy grade of >2 (Baron Scale).
•4) Patients requiring long term treatment with oral steroids for any medical condition.
•5) Women who are pregnant or lactating.
•6) Patients with known HIV infection.
•7) Other serious medical or psychiatric illness currently ongoing, or experienced within the past three months, that in the opinion of the investigator would compromise the study.
•8) Patients unable to comply with the protocol requirements, including severe alcohol and drug misuse or abuse

发起方

niversity of Nottingham