No registrations found.
ID
Source
Brief title
Health condition
Systemic Lupus Erythematosus, SLE
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary goal is to investigate the possibility of generating fully human monoclonal antibodies against type I interferons (IFNs) from B cells of SLE patients.
Secondary outcome
N/A
Background summary
Blood will be collected from patients with a diagnosis of SLE. The initial study is aimed at generating fully human monoclonal antibodies against type I IFNs from B cells of SLE patients. For this purpose, 50 mL blood from three SLE patients, whose serum contains autoantibodies against type I IFNs, is required.
Study objective
Interferons (IFNs) are a family of cytokines which have important antiviral and antiproliferative properties. They also play an important role in immunomodulation. Type I IFNs have been implicated in autoimmune diseases, including systemic lupus erythematosus (SLE), where progressive loss of tolerance to nuclear antigens leads to a heterogenous, multisystem disease course characterized by flares and remissions.
The natural occurrence of autoantibodies against type I IFNs has already been described in the early 1980s in patients with SLE, acute viral infections, and malignancies. These findings imply the presence and activation of B cells, which are specific for the indicated cytokine, and it is possible that monoclonal anti-IFN antibodies derived from B cells of SLE patients have clinical value.
Study design
N/A
Intervention
No intervention, observational study with invasive measurements.
P.O. Box 22660
P.P. Tak
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
p.p.tak@amc.nl
P.O. Box 22660
P.P. Tak
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
p.p.tak@amc.nl
Inclusion criteria
Male and female patients with a diagnosis of SLE and whose serum contains autoantibodies against type I IFNs.
Exclusion criteria
1. Use of or history of use of B cell-directed therapies;
2. Pregnancy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2772 |
| NTR-old | NTR2912 |
| Other | METC AMC : 2011-085 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |