Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis
Status:
Completed
Trial end date:
2005-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust