Status:
COMPLETED
Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Systemic Lupus Erythematosus
ANCA Associated Vasculitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 standar...
Eligibility Criteria
Inclusion
- 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)
- Age 18-70
Exclusion
- HbeAg or HCV Ab positive or known HIV positivity ( HIV testing not necessary for this study)
- Pregnancy, inadequate contraception or lactation
- Malignancy
- Current enrolment in pother clinicla trials -
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00293072
Start Date
March 1 2002
End Date
May 1 2005
Last Update
February 17 2006
Active Locations (1)
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1
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ