TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL )
Status:
Terminated
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Medical University of Vienna
Collaborators:
Charite University, Berlin, Germany Heinrich-Heine University, Duesseldorf Hospital Hietzing Leiden University Medical Center Medical University of Graz Radboud University University Medical Center Groningen University of Erlangen-Nürnberg