TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL )
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00368264|
Recruitment Status : Terminated (Failure to recruit patients with membranous lupus nephritis not previously treated with azathioprine .)
First Posted : August 24, 2006
Last Update Posted : October 5, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Lupus Erythematosus, Systemic Lupus Nephritis||Drug: infliximab Drug: placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
U.S. FDA Resources
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
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|