Clinical Trial: Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional Therapy
Brief Summary: 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.
Detailed Summary:
Sponsor: Cambridge University Hospitals NHS Foundation Trust
Current Primary Outcome:
- 1. Clinical remission at 6 or 12 months
- 2. Absence of a severe life threatening adverse event
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Cambridge University Hospitals NHS Foundation Trust
Dates:
Date Received: February 16, 2006
Date Started: March 2002
Date Completion: May 2005
Last Updated: February 16, 2006
Last Verified: October 2005
