Ciclosporin and azathioprine treatment in severe ulcerative colitis: a double-blind controlled trial to evaluate short and long-term outcome

Completed

Conditions: Severe ulcerative colitis
Digestive System
Ulcerative colitis

Registration Number: ISRCTN56331683

Lead Sponsor: niversity of Nottingham (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 280

Inclusion Criteria

Patients admitted to hospital with severe ulcerative colitis, who have been treated with intravenous corticosteroids for between 48 hours and 5 days, and still fulfil Truelove and Witts criteria for severe colitis.

Exclusion Criteria

1. Positive stool culture for enteric pathogens or Clostridium difficile
2. Cholesterol level below 3 mM
3. Greater than 5 days treatment with intravenous corticosteroids
4. Crohn's disease
5. Bowel perforation, or obstructive symptoms not due substantially to active inflammation
6. Pregnancy or lactation, or inability to take contraception during the trial
7. Treatment with ciclosporin tacrolimus or infliximab in the three months prior to study entry
8. Serious intercurrent infection or other active disease within three months prior to treatment
9. History of concurrent malignancy, or evidence of colonic dysplasia
10. Known human immunodeficiency virus (HIV) infection
11. Toxic dilation of the colon or clinical condition where colectomy is highly likely
12. Significant renal impairment (serum creatinine above 130 uM)
13. Uncontrolled hypertension

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All Patients Treated disease status at six months, defined as:<br>Treatment success = no colectomy and remission off steroid therapy<br>Partial treatment success = symptoms of active disease, or treatment with steroids (oral or enema)<br>Treatment failure = colectomy

Secondary Outcome Measures

Name	Time	Method
1. Treatment outcome at two years (All Patients Treated disease status as defined for primary end-point above)<br>2. Treatment outcome at three months (All Patients Treated disease status as defined for primary outcome above)<br>3. Treatment response at 7 days (three or fewer non-bloody stools)<br>4. Time to remission and time to subsequent relapse measured by life table analysis<br>5. Quality of life at 6 months assessed using the McMaster inflammatory bowel disease questionnaire and EQ-5D scores<br>6. Overall incidence of adverse events<br>7. Employment status and amount of sick leave during follow-up<br>8. Patients valuation of outcome expressed in terms of time trade-off