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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50392
Enrollment
80
Registered
2017-02-28
Start date
2017-03-23
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MG Myasthenia gravis Pemphigus

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Primary Objective: - To isolate PBMC from patients with AChR MG, MuSK MG, LEMS or pemphigus to determine the pathogenic B cell receptor sequences.

Secondary

MeasureTime frame
Secondary Objective(s): - To generate recombinant antibodies derived from pathogenic auto-antibodies from AChR MG, MuSK MG, LEMS or pemphigus patients. - To determine the phenotype of pathogenic antibody producing B cells. - To correlate disease severity and other patient characteristics with pathogenic antibody producing B cell numbers and B cell receptor sequences.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)