Rituximab in Ulcerative Colitis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2004 by Royal Liverpool University Hospital.
Recruitment status was Recruiting
Information provided by:
Royal Liverpool University Hospital
First received: November 29, 2005
Last updated: February 1, 2006
Last verified: October 2004
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 circulation. These cells have the capacity to generate the auto-antibodies that typify auto-immune disease. Although Rituximab has been mainly used for treating B lymphocyte malignancies (lymphoma) it has also been used with promising results in Rheumatoid arthritis and has an excellent safety recortd. This is a small placebo-controlled trial to assess its efficacy and safety in patients with steroid-resistant active ulcerative colitis.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||Phase 3: Randomised Controlled Trial of Rituximab in Active Ulcerative Colitis
Primary Outcome Measures:
- Remission defined as a decrease in Mayo score to ≤ 2 points at week 4
Secondary Outcome Measures:
- Clinical response defined as a decrease in Mayo score by ≥ 3 points at weeks 4, 8 (partial Mayo score) and 12.
- Remission at weeks 8 and 12.
- Endoscopic mucosal healing at week 4 and 12
- Improvement in Inflammatory Bowel Disease specific Quality of Life Index  [Appendix 2] at weeks 4 and 12
- Histological improvement of disease activity at 4 and 12 weeks compared with baseline. Scored as follows:
- 0 = no polymorphs
- 1 = small numbers of polymorphs in the lamina propria with minimal infiltration of crypts
- 2 = prominent polymorphs in the lamina propria with infiltration of ³ 50% of crypts
- 3 = florid polymorph infiltrate with crypt abscesses
- 4 = florid acute inflammation with ulceration
- Treatment tolerability as defined by adverse events.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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  of 6-12 inclusive (see Appendix 1)
- 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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261118
|Royal Liverpool University Hospital
|Liverpool, Merseyside, United Kingdom, L7 8XP |
|Contact: Kate Martin, RGN 441517064194 firstname.lastname@example.org |
|Contact: Jonathan M Rhodes, MD 441517064073 email@example.com |
|Sub-Investigator: Keith Leiper, MB |
Royal Liverpool University Hospital
||Jonathan M Rhodes, MD
||University of Liverpool
No publications provided by Royal Liverpool University Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
History of Changes
|Other Study ID Numbers:
||RLBUHT R&D 2709, DDX exemption from MRHA ref:-, MF 8000/12794
|Study First Received:
||November 29, 2005
||February 1, 2006
||United Kingdom: Medicines and Healthcare Products Regulatory Agency
Keywords provided by Royal Liverpool University Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 09, 2014
Digestive System Diseases
Inflammatory Bowel Diseases
Physiological Effects of Drugs