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Auto-antibody sequencing in patients with autoimmune myasthenia gravis and pemphigus

Recruiting
Conditions
MG
Myasthenia gravis
Pemphigus
10003816
Registration Number
NL-OMON50392
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
80
Inclusion Criteria

For myasthenia gravis:
1. Males and females aged between 18 years and older at the time of the
blood donation.
2. Patient with ocular or generalized AChR MG, MuSK MG or LEMS; and
3. A positive serologic test for AChR antibodies > 0.5 nmol/l or MuSK
antibodies >0.1 nmol/l or VGCC antibodies >20 fmol/l. , For Pemphigus:
1. Males and females aged between 18 years and older at the time of the blood
donation.
2. Patient with pemphigus subtypes and
3. A positive serologic test for Dsg1 antibodies > 0.5 nmol/l or Dsg3
antibodies >0.1 nmol/l.

Exclusion Criteria

For myasthenia gravis and pemphigus:
1. Any confirmed or suspected immunosuppressive or immunodeficient condition
not related to the treatment of MG, including human immunodeficiency virus
(HIV) infection, or a family history of congenital or hereditary
immunodeficiency.
2. History or evidence of administration of immunoglobulins within 1 month
prior to the blood withdrawal.
3. The investigator can exclude patients for this trial which are deemed not
suitable for any reason.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary Objective:<br /><br>- To isolate PBMC from patients with AChR MG, MuSK MG, LEMS or pemphigus to<br /><br>determine the pathogenic B cell receptor sequences.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary Objective(s):<br /><br>- To generate recombinant antibodies derived from pathogenic auto-antibodies<br /><br>from AChR MG, MuSK MG, LEMS or pemphigus patients.<br /><br>- To determine the phenotype of pathogenic antibody producing B cells.<br /><br>- To correlate disease severity and other patient characteristics with<br /><br>pathogenic antibody producing B cell numbers and B cell receptor sequences.</p><br>
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