Clinical trial · Observational

Interleukin and Autoantibodies in Myasthenia Gravis.

Expression Levels of Interleukin 37 and Its Correlation With Autoantibodies and Disease Severity in Myasthenia Gravis Patients

NCT05301153CI-TRIAL-00058219unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Myasthenia gravis is a B-cell-mediated autoimmune disorders causing muscle weakness due to defective synaptic transmission at the neuromuscular junction caused by autoantibodies to acetylcholine receptors in (∼85%), muscle specific kinase in 6% and low-density lipoprotein receptor-related protein 4.The detection of these autoantibodies is very important not only in the diagnosis, but also for the stratification of Myasthenia Gravis patients into respective subgroups. These groups can differ in clinical manifestations, prognosis and response to therapies which become relevant for the development of antigen-specific therapies, targeting only the specific autoantibodies involved in the autoimmune response.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Myasthenia Gravis	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
real time PCR , ELISA	Diagnostic Test	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
Myasthenia Gravis cases
description
1. Collection of Peripheral Blood Peripheral blood mononuclear cells (PBMCs) will be isolated from freshly drawn heparinized blood by ficoll density gradient centrifugation according to the manufacturer's protocol. 2. Real-Time Reverse Transcription -PCR (RT-PCR) Real-time RT PCR will be performed on complementary DNA produced from 250 ng total RNA using the following primers Interleukin 37, F: 59-CAGTGAGGTCAGCGATTAGGAA-39 R: 59-TTAGTGAGCAGGTTTGGTGTTTT-39 b-actin, F: 59-CACCATTGGCAATGAGCGGTTC-39 R 59-AGGTCTTTGCGGATGTCCACGT-39. 3. Autoantibodies detection: Detection of autoantibodies to muscle specific kinase (MuSK) and low-density lipoprotein receptor-related protein 4 (LRP4) serum levels by ELISA according to the manufacturer's protocol.
interventionNames
1. Diagnostic Test: real time PCR , ELISA
label
Healthy Control
description
1. Collection of Peripheral Blood Peripheral blood mononuclear cells (PBMCs) will be isolated from freshly drawn heparinized blood by ficoll density gradient centrifugation according to the manufacturer's protocol. 2. Real-Time Reverse Transcription -PCR (RT-PCR) Real-time RT PCR will be performed on complementary DNA produced from 250 ng total RNA using the following primers Interleukin 37, F: 59-CAGTGAGGTCAGCGATTAGGAA-39 R: 59-TTAGTGAGCAGGTTTGGTGTTTT-39 b-actin, F: 59-CACCATTGGCAATGAGCGGTTC-39 R 59-AGGTCTTTGCGGATGTCCACGT-39.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 60 Years

Show eligibility criteria text

Inclusion Criteria:

1. Clinical Diagnosis of Myasthenia Gravis.
2. Willingness to sample collection.

Exclusion Criteria:

1. History of chronic psychiatric or neurological disorder other than Myasthenia Gravis that can produce weakness or fatigue.
2. Severe systemic illness affecting life-expectancy ( chronic liver or kidney diseases).
3. History of autoimmune diseases, connective tissue diseases, , or genetic diseases.
4. Patients on large dosage of immune-suppressive treatment or Intravenous immunoglobulin in the recent 3 months.

References

Publications (5)

RESULTFichtner ML, Jiang R, Bourke A, Nowak RJ, O'Connor KC. Autoimmune Pathology in Myasthenia Gravis Disease Subtypes Is Governed by Divergent Mechanisms of Immunopathology. Front Immunol. 2020 May 27;11:776. doi: 10.3389/fimmu.2020.00776. eCollection 2020. PMID 32547535
RESULTLazaridis K, Tzartos SJ. Autoantibody Specificities in Myasthenia Gravis; Implications for Improved Diagnostics and Therapeutics. Front Immunol. 2020 Feb 14;11:212. doi: 10.3389/fimmu.2020.00212. eCollection 2020. PMID 32117321
RESULTCrotty S. Follicular helper CD4 T cells (TFH). Annu Rev Immunol. 2011;29:621-63. doi: 10.1146/annurev-immunol-031210-101400. PMID 21314428
RESULTKing C, Tangye SG, Mackay CR. T follicular helper (TFH) cells in normal and dysregulated immune responses. Annu Rev Immunol. 2008;26:741-66. doi: 10.1146/annurev.immunol.26.021607.090344. PMID 18173374
RESULTLiu Z, Zhu L, Lu Z, Chen H, Fan L, Xue Q, Shi J, Li M, Li H, Gong J, Shi J, Wang T, Jiang ML, Cao R, Meng H, Wang C, Xu Y, Zhang CJ. IL-37 Represses the Autoimmunity in Myasthenia Gravis via Directly Targeting Follicular Th and B Cells. J Immunol. 2020 Apr 1;204(7):1736-1745. doi: 10.4049/jimmunol.1901176. Epub 2020 Feb 28. PMID 32111731