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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 |
| Genetics Home Reference related topics: | Crohn disease |
| MedlinePlus related topics: | Ulcerative Colitis |
| ChemIDplus related topics: | Rituximab |
| 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 |
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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:
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 | |||||
| Royal Liverpool University Hospital |
| Hoffmann-La Roche |
| 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 |
| First Received: | November 29, 2005 |
| Last Updated: | February 1, 2006 |
| ClinicalTrials.gov Identifier: | NCT00261118 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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