TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL )
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.
- 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).
- This combination therapy will show a tolerable safety profile with regard to SLE activity and infections.
|Lupus Erythematosus, Systemic Lupus Nephritis||Drug: infliximab Drug: placebo||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Comparison of time needed to reduce proteinuria to 1.5 g/day or less between the infliximab plus azathioprine and the azathioprine only group.
- Percentage of patients reaching reduction in proteinuria to ≤ 1.5 g/day, at week 12 and week 52.
- Percent reduction in proteinuria at 6 weeks, 12 weeks, 20 weeks, 36 weeks, and 52 weeks after the first infusion.
- Absolute reduction in proteinuria at 6 weeks, 12 weeks, 20 weeks, 36 weeks, and 52 weeks after the first infusion.
- Percent reduction in protein/ creatinine ratio.
- Percent reduction in SLE disease activity (measured by SIS and SLEDAI).
- Absolute reduction in SLE disease activity (measured by SIS and SLEDAI).
- Changes in Quality of life as determined by the SF36 questionnaire.
- Changes in Fatigue as determined by the FSS (Fatigue Severity Scale).
|Study Start Date:||September 2006|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
azathioprine plus 4 infusions of infliximab (5 mg/kg)
azathioprine (2 mg/lkg) plus four infusions of infliximab (5mg/kg)
Placebo Comparator: 2
azathioprine plus 4 placebo infusions
azathioprine (2 mg/kg) plus four placebo infusions
Please refer to this study by its ClinicalTrials.gov identifier: NCT00368264
|Departments of Rheumatology, Internal Medicine, Medical University of Graz|
|Graz, Austria, A-8036|
|Rheumatology, Internal Medicine III, Medical University of Vienna|
|Vienna, Austria, A-1090|
|Internal Medicine II, Hietzing Hospital|
|Vienna, Austria, A-1130|
|Berlin, Germany, D-10117|
|Rheumatology, University of Düsseldorf|
|Düsseldorf, Germany, D-40225|
|Internal Medicine III, University of Erlangen|
|Erlangen, Germany, D-91023|
|Clinical Immunology, Groningen University Hospital|
|Groningen, Netherlands, 9713 GZ|
|Leiden University Medical Center, Netherlands|
|Leiden, Netherlands, 2300 RC|
|Nephrology, University of Nymegen, Netherlands|
|Nijmegen, Netherlands, G6525 GA|
|Study Chair:||Josef S Smolen, MD||Head, Department of Rheumatology, Internal Medicine III, Medical University of Vienna, Austria|
|Principal Investigator:||Martin Aringer, MD||Department of Rheumatology, Internal Medicine III, Medical University of Vienna, Austria|
|Principal Investigator:||Falk Hiepe, MD||Rheumatology, Charite, Berlin, Germany|
|Principal Investigator:||Marc Bijl, MD||Clinical Immunology, Groningen University Hospital, Netherlands|