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Rituximab in Ulcerative Colitis
This study is currently recruiting participants.
Verified by Royal Liverpool University Hospital, October 2004
First Received: November 29, 2005   Last Updated: February 1, 2006   History of Changes
Sponsors and Collaborators: Royal Liverpool University Hospital
Hoffmann-La Roche
Information provided by: Royal Liverpool University Hospital
ClinicalTrials.gov Identifier: NCT00261118
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Drug: Rituximab
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Phase 3: Randomised Controlled Trial of Rituximab in Active Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Royal Liverpool University Hospital:

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 [22] [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: 24
Study Start Date: April 2004
Estimated Study Completion Date: December 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients over age of 18 years who are capable of providing written informed consent.
  2. Confirmed diagnosis of ulcerative colitis by conventional clinical, endoscopic and histological criteria.
  3. Failure of response to at least two weeks of oral prednisolone 40mg/day.
  4. Active colitis as assessed by a Mayo score [21] of 6-12 inclusive (see Appendix 1)

Exclusion Criteria:

1. Patients under 18 or unable to give informed consent. 2. Patients in their first attack of ulcerative colitis. 3. 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. 4. Patients who are pregnant, post partum (<3months) or breast feeding 5. Patients who are at risk of pregnancy and not using a reliable form of contraception (oral contraceptive and barrier or barrier plus spermicide). 6. Patients with a stoma 7. Positive stool culture for pathogens or test for C difficile at screening within 7 days prior to trial entry 8. 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) 9. Any change to maintenance medication for ulcerative colitis: azathioprine or 6-mercaptopurine within previous 3 months or 5-aminosalicylates within previous one month 10. Any change to rectal therapy for colitis within the previous two weeks. 11. Participation in other trials in the last 3 months. 12. Serious intercurrent infection or other clinically important active disease (including renal and hepatic disease)

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261118

Contacts
Contact: Kate Martin, RGN 441517064194 kate.martin@rlbuht.nhs.uk
Contact: Jonathan M Rhodes, MD 441517064073 rhodesjm@liverpool.ac.uk

Locations
United Kingdom, Merseyside
Royal Liverpool University Hospital Recruiting
Liverpool, Merseyside, United Kingdom, L7 8XP
Contact: Kate Martin, RGN     441517064194     kate.martin@rlbuht.nhs.uk    
Contact: Jonathan M Rhodes, MD     441517064073     rhodesjm@liverpool.ac.uk    
Sub-Investigator: Keith Leiper, MB            
Sponsors and Collaborators
Royal Liverpool University Hospital
Hoffmann-La Roche
Investigators
Principal Investigator: Jonathan M Rhodes, MD University of Liverpool
  More Information

No publications provided

Study ID Numbers: RLBUHT R&D 2709, DDX exemption from MRHA ref:-, MF 8000/12794
Study First Received: November 29, 2005
Last Updated: February 1, 2006
ClinicalTrials.gov Identifier: NCT00261118     History of Changes
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Royal Liverpool University Hospital:
colitis
rituximab

Study placed in the following topic categories:
Digestive System Diseases
Immunologic Factors
Rituximab
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Antirheumatic Agents
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:
Immunologic Factors
Antineoplastic Agents
Gastrointestinal Diseases
Rituximab
Ulcer
Colonic Diseases
Physiological Effects of Drugs
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Pharmacologic Actions
Digestive System Diseases
Pathologic Processes
Therapeutic Uses
Antirheumatic Agents
Gastroenteritis
Colitis

ClinicalTrials.gov processed this record on July 06, 2009