Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368264
Status:
TERMINATED
Last Update Posted:
2009-10-05
First Post:
2006-08-23
Brief Title:
TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V TRIAL
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Failure to recruit patients with membranous lupus nephritis not previously treated with azathioprine
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgkg of body weightadministered at weeks 0 26 and 10 with azathioprine will be faster than azathioprine alone in reducing proteinuria to less than 15 gday in patients with active lupus nephritis WHO class V proteinuria 3gday
2 This combination therapy will show a tolerable safety profile with regard to SLE activity and infections
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 mgkg of body weightadministered at weeks 0 26 and 10 with azathioprine will be faster than azathioprine alone in reducing proteinuria to less than 15 gday in patients with active lupus nephritis WHO class V proteinuria 3gday
2 This combination therapy will show a tolerable safety profile with regard to SLE activity and infections
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EK Nr1102006 | None | None | None |
| Eudract-Nr 2005-004067-30 | None | None | None |
| Protocol EU-116 | None | None | None |