Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis
Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis
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.
Inclusion Criteria:

 1. Diagnosis of SLE or ANCA associated vasculitis

 2. Active disease refractory to 6 months conventional therapy with cyclophosphamide,
 prednisolone and at least one other immunosupressive agent ( or a lesser period if
 this therapy cannot be tolerated)

 3. Age 18-70

 Exclusion Criteria:

 1. HbeAg or HCV Ab positive or known HIV positivity ( HIV testing not necessary for this
 study)

 2. Pregnancy, inadequate contraception or lactation

 3. Malignancy

 4. Current enrolment in pother clinicla trials -