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AMC SLE antibodies.


- candidate number9461
- NTR NumberNTR2912
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-mei-2011
- Secondary IDs2011-085 METC AMC
- Public TitleAMC SLE antibodies.
- Scientific TitleGeneration of Anti-Cytokine Antibodies from B Cells of Patients with Systemic Lupus Erythematosus.
- ACRONYMSLE antibodies
- hypothesisInterferons (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.
- Healt Condition(s) or Problem(s) studiedSystemic lupus erythematosus (SLE)
- Inclusion criteriaMale and female patients with a diagnosis of SLE and whose serum contains autoantibodies against type I IFNs.
- Exclusion criteria1. Use of or history of use of B cell-directed therapies;
2. Pregnancy.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mei-2011
- planned closingdate31-dec-2011
- Target number of participants10
- InterventionsNo intervention, observational study with invasive measurements.
- Primary outcomeThe 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 outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. P.P. Tak
- CONTACT for SCIENTIFIC QUERIESProf. Dr. P.P. Tak
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryBlood 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.
- Main changes (audit trail)
- RECORD23-mei-2011 - 5-jun-2011


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