Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy on Systemic Lupus Erythematosus

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This prospective randomized control trial is undertaken to evaluate the safety and efficacy of anti-CD20 monoclonal antibody, rituximab, used as 1. monotherapy, 2. in combination with cyclophosphamide, in the treatment of proliferative lupus nephritis, as compared with standard immunosuppressive therapy with cyclophosphamide and azathioprine.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Cyclophosphamide; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rituximab

Criteria

Inclusion Criteria:

• Age > 18 years

• Active proliferative lupus nephrites

• Biopsy confirmed active proliferative lupus nephritis within 3 months prior to enrollment

• Proteinuria >= 2g/day

• Active urinary sediments

• Activity index of >= 6

• Elevated anti-double-stranded(anti-dsDNA) level at baseline

• Agreement to practice birth control

• SLE according to the American College of Rheumatology Criteria

• Informed consent was obtained

Exclusion Criteria:

• Pre-existing renal failure

• History of cancer

• Human immunodeficiency virus infection

• Active hepatitis B or C infection

• Active tuberculosis

• Diabetes mellitus

• A ny other chronic disease

• Unwillingness to comply with the protocol