Trial Information
Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional Therapy
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 -
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
1. Clinical remission at 6 or 12 months
Principal Investigator
Ken Smith
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cambridge Institute for Medical Research, Addenbrooke's Hospital
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
Pilot study of Rituximab
NCT ID:
NCT00293072
Start Date:
March 2002
Completion Date:
May 2005
Related Keywords:
- Systemic Lupus Erythematosus
- ANCA Associated Vasculitis
- Rituximab, ANCA, vasculitis, lupus,
- Lupus Erythematosus, Systemic
- Vasculitis
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis