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| 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 |
| 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 |
Inclusion Criteria:
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| Contact: Kate Martin, RGN | 441517064194 | kate.martin@rlbuht.nhs.uk |
| Contact: Jonathan M Rhodes, MD | 441517064073 | rhodesjm@liverpool.ac.uk |
| 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 | |
| Principal Investigator: | Jonathan M Rhodes, MD | University of Liverpool |
More Information
| 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 |
|
colitis rituximab |
|
Digestive System Diseases Immunologic Factors Rituximab Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Antirheumatic Agents Intestinal Diseases Gastroenteritis Colitis |
|
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 |