NCT00368264

TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL )

A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNF-alpha Chimeric Monoclonal Antibody (Infliximab) and Azathioprine in Patients Suffering From Systemic Lupus Erythematosus (SLE) With WHO Class V Glomerulonephritis

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: Standard therapy is ill-defined for patients with systemic lupus erythematosus (SLE) suffering from the membraneous form of Lupus nephritis (WHO class V). Therapeutic options used at present include azathioprine. In a small, open label safety study, patients with lupus nephritis, including patients with membraneous lupus nephritis, have experienced a long-lasting therapeutic response, with sustained reduction in proteinuria, following a 10 weeks course of 4 infusions of infliximab in combination with azathioprine. This short course appeared safe with regard to SLE activity, despite increases in autoantibody levels. Study hypothesis: 1. The combination of four infusions of infliximab (5 mg/kg of body weight)administered at weeks 0, 2,6, and 10, with azathioprine will be faster than azathioprine alone in reducing proteinuria to less than 1.5 g/day in patients with active lupus nephritis WHO class V (proteinuria \> 3g/day). 2. This combination therapy will show a tolerable safety profile with regard to SLE activity and infections.

Conditions

• Lupus Erythematosus, Systemic
• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	infliximab	azathioprine (2 mg/lkg) plus four infusions of infliximab (5mg/kg)
DRUG	placebo	azathioprine (2 mg/kg) plus four placebo infusions

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2006-08-24
• Last updated: 2009-10-05

Locations

9 sites across 3 countries: Austria, Germany, Netherlands