Status:
COMPLETED
Rituximab in Active Ulcerative Colitis
Lead Sponsor:
Royal Liverpool University Hospital
Collaborating Sponsors:
Hoffmann-La Roche
University of Liverpool
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
There is broad support for the hypothesis that Ulcerative colitis is an auto-immune disease. Rituximab is an antibody protein that removes a subgroup of white blood cells (B lymphocytes) from the circ...
Detailed Description
WHAT IS THE PROBLEM TO BE ADDRESSED ? Lack of effective cure for Ulcerative colitis. WHAT IS THE HYPOTHESIS TO BE TESTED? That rituximab may be effective in active ulcerative colitis. WHY IS A TRI...
Eligibility Criteria
Inclusion
- Patients over age of 18 years who are capable of providing written informed consent.
- Confirmed diagnosis of ulcerative colitis by conventional clinical, endoscopic and histological criteria.
- Failure of response to at least two weeks of oral prednisolone 40mg/day.
- Active colitis as assessed by a Mayo score \[21\] of 6-12 inclusive (see Appendix 1)
Exclusion
- Patients under 18 or unable to give informed consent.
- Patients in their first attack of ulcerative colitis.
- Patients with severe ulcerative colitis as defined by presence of any of: temperature \>37.5oC, pulse rate \>100, focal severe or rebound abdominal tenderness, haemoglobin \< 10.0g/dl, serum albumin \<3.5 g/dl, transverse colon diameter greater than 5.0cms on plain abdominal X ray.
- Patients who are pregnant, post partum (\<3months) or breast feeding
- Patients who are at risk of pregnancy and not using a reliable form of contraception (oral contraceptive and barrier or barrier plus spermicide).
- Patients with a stoma
- Positive stool culture for pathogens or test for C difficile at screening within 7 days prior to trial entry
- Patients for whom a baseline Mayo score can not be reliably calculated: frequent use of laxatives (for proximal constipation) or antimotility agents (for control of diarrhoea)
- Any change to maintenance medication for ulcerative colitis: azathioprine or 6-mercaptopurine within previous 3 months or 5-aminosalicylates within previous one month
- Any change to rectal therapy for colitis within the previous two weeks.
- Participation in other trials in the last 3 months.
- Serious intercurrent infection or other clinically important active disease (including renal and hepatic disease)
- \-
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00261118
Start Date
April 1 2004
End Date
October 1 2009
Last Update
November 6 2014
Active Locations (1)
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1
Royal Liverpool University Hospital
Liverpool, Merseyside, United Kingdom, L7 8XP