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Sponsors and Collaborators: |
Cambridge University Hospitals NHS Foundation Trust Hoffmann-La Roche |
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Information provided by: | Cambridge University Hospitals NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT00293072 |
Lupus and vasculitis are autoimmune conditions which can be life threatening. In order to treat these conditions toxic therapies such as cyclophosphamide and steroids are often required. These standard treatments are associated with significant side effects. Furthermore a proportion of patient do not respond to these conventional therapies. Newer safer therapies are being sought. Rituximab is a drug that eliminates B cell from the blood. B cells are one part of the human immune system that helps prevent infections. Abnormal activity of the immune system is responsible for autoimmune disease although the exact mechanisms in lupus and vasculitis are not yet established. Rituximab is liscenced as a treatment for a form of B cell cancer called non-Hodgkins Lymphoma and has a good safety track record when used in this context. It has recently been used to treat some autoimmune conditions with positive results. In this pilot study we wish to assess the effectiveness and safety of rituximab in patients with lupus and vascultis that are resistant to conventional therpies.
Condition | Intervention | Phase |
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Systemic Lupus Erythematosus ANCA Associated Vasculitis |
Drug: Rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional Therapy |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom, Cambridgeshire | |
Addenbrooke's Hospital | |
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ |
Principal Investigator: | Ken Smith | Cambridge Institute for Medical Research, Addenbrooke's Hospital |
Principal Investigator: | David Jayne | Lupus and Vasculitis Service, Addenbrooke's Hospital |
Study ID Numbers: | Pilot study of Rituximab |
Study First Received: | February 16, 2006 |
Last Updated: | February 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00293072 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Rituximab, ANCA, vasculitis, lupus, |
Autoimmune Diseases Vasculitis Immunologic Factors Lupus Erythematosus, Systemic Rituximab |
Lupus Vascular Diseases Connective Tissue Diseases Antirheumatic Agents |
Vasculitis Autoimmune Diseases Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs |
Vascular Diseases Pharmacologic Actions Lupus Erythematosus, Systemic Therapeutic Uses Connective Tissue Diseases Cardiovascular Diseases Antirheumatic Agents |