A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNF alfa Chimeric Monoclonal Antibody (Infliximab, Remicade) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis.
Phase 3
Not yet recruiting
- Conditions
- Lupus1000381610029149
- Registration Number
- NL-OMON30091
- Lead Sponsor
- Medical University of Vienna AKH, Department of Rheumatology, Internal Medicine III, Josef Smolen, MD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
-SLE with biopsy-proven membranous glomerulonephritis (WHO class V)
-Proteinuria >3g/day despite adequate therapy with ACE inhibitors
-Individuals (>18 years) who have the capacity to understand and sign an informed consent
-No evidence of current active TB or old inactive TB
Exclusion Criteria
-Active WHO class IV SLE nephritis
-Treatment with azathioprine / cyclophosphamide within the previous 12 months, or with cyclosporine within the previous 6 weeks
-Active cerebral SLE
-Active infection, malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Comparison of time needed to reduce proteinuria 1.5 g/day or less between the<br /><br>infliximab plus azathioprine and the azathioprine only group.</p><br>
- Secondary Outcome Measures
Name Time Method <p>-Percentage of patients reaching reduction in proteinuria to <= 1.5 g/day, at<br /><br>week 12 and week 52.<br /><br>-Percent reduction in proteinuria at 6 weeks, 12 weeks, 20 weeks, 36 weeks, and<br /><br>52 weeks after the first infusion.<br /><br>-Absolute reduction in proteinuria at 6 weeks, 12 weeks, 20 weeks, 36 weeks,<br /><br>and 52 weeks after the first infusion.<br /><br>-Percent reduction in SLE disease activity<br /><br>-Absolute reduction in SLE disease activity<br /><br>-Changes in Quality of life<br /><br>-Changes in Fatigue</p><br>