Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional Therapy
Overview
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 1. Clinical remission at 6 or 12 months
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of SLE or ANCA associated vasculitis
- •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)
Exclusion Criteria
- •HbeAg or HCV Ab positive or known HIV positivity ( HIV testing not necessary for this study)
- •Pregnancy, inadequate contraception or lactation
- •Current enrolment in pother clinicla trials -
Outcomes
Primary Outcomes
1. Clinical remission at 6 or 12 months
2. Absence of a severe life threatening adverse event
Secondary Outcomes
No secondary outcomes reported