Ciclosporin and azathioprine treatment in severe ulcerative colitis: a double-blind controlled trial to evaluate short and long-term outcome
| ISRCTN | ISRCTN56331683 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56331683 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/05/2005
- Registration date
- 20/07/2005
- Last edited
- 30/07/2014
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Christopher J Hawkey
Scientific
Scientific
Wolfson Digestive Diseases Centre
University Hospital
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 9709353 |
|---|---|
| cj.hawkey@nottingham.ac.uk |
Study information
| Study design | Randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | UC CAT |
| Study objectives | Does use of oral microemulsion ciclosporin, followed by azathioprine, in patients admitted to hospital with acute severe ulcerative colitis reduce the need for colectomy in the short term (at six months), and long term (two years)? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Severe ulcerative colitis |
| Intervention | Oral microemulsion of ciclosporin (5.5 to 6.5 mg/kg/day twice a day [bd]) or matched placebo. All patients continue to receive intravenous hydrocortisone and other standard medical therapy. At discharge, patients will start treatment with azathioprine (50 mg daily, increasing to 2 mg/kg after two weeks) and a tapering dose of prednisolone. Updated 30/07/2014: the trial was stopped due to poor recruitment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ciclosporin, azathioprine, hydrocortisone, prednisolone |
| Primary outcome measure | All Patients Treated disease status at six months, defined as: Treatment success = no colectomy and remission off steroid therapy Partial treatment success = symptoms of active disease, or treatment with steroids (oral or enema) Treatment failure = colectomy |
| Secondary outcome measures | 1. Treatment outcome at two years (All Patients Treated disease status as defined for primary end-point above) 2. Treatment outcome at three months (All Patients Treated disease status as defined for primary outcome above) 3. Treatment response at 7 days (three or fewer non-bloody stools) 4. Time to remission and time to subsequent relapse measured by life table analysis 5. Quality of life at 6 months assessed using the McMaster inflammatory bowel disease questionnaire and EQ-5D scores 6. Overall incidence of adverse events 7. Employment status and amount of sick leave during follow-up 8. Patients valuation of outcome expressed in terms of time trade-off |
| Overall study start date | 01/06/2005 |
| Completion date | 31/05/2011 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 280 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 31/05/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Wolfson Digestive Diseases Centre
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
Research Support & Commercialisation Office
University Park
Nottingham
NG7 2RD
England
United Kingdom
"ROR" |
https://ror.org/01ee9ar58 |
|---|
Funders
Funder type
Industry
Novartis Pharmaceuticals UK Ltd (UK) - unconditional block grant (ref: COLO400A 2423)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
