The medical condition is Ulcerative Colitis.
Conditions
Interventions
Product Name: products containing azathioprine or 6-mercaptopurine
Pharmaceutical Form: Tablet
INN or Proposed INN: azathioprine
Concentration unit: mg
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study will help define the medical management for patients with difficult ulcerative colitis who have achieved remission on azathioprine (or 6-mercaptopurine) and on an aminosalicylate. It is important to determine whether, after the introduction of azathioprine with remission established, there is any extra benefit in continuing the aminosalicylate treatment;Secondary Objective: To identify factors predictive of the success of the different maintenance treatment regimes;Primary end point(s): Relapse of colitis, defined by symptoms and sigmoidoscopy findings. | — |
Countries
United Kingdom
Outcome results
None listed