Myasthenia GravisNCT05301153
Interleukin and Autoantibodies in Myasthenia Gravis.
An observational study of Myasthenia Gravis, run by Assiut University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- real time PCR , ELISA
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The estimated minimum required sample size is 84 cases (42 case in each group). sample size was calculated using G*power software 3.1.9.7. As this study aims to detect the large difference between the the group of Myasthenia Gravis patients relative to the healthy controls, so the calculation based on determining the large effect size. Main statistical test is two tailed t-test to detect difference between two groups . Effect size = 0.8 Alpha = 0.05 Power = 0.95 Allocation ratio = 1
Who may be able to join
- Clinical Diagnosis of Myasthenia Gravis.
- Willingness to sample collection.
Who cannot join
- History of chronic psychiatric or neurological disorder other than Myasthenia Gravis that can produce weakness or fatigue.
- Severe systemic illness affecting life-expectancy ( chronic liver or kidney diseases).
- History of autoimmune diseases, connective tissue diseases, , or genetic diseases.
- Patients on large dosage of immune-suppressive treatment or Intravenous immunoglobulin in the recent 3 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Expression Levels of Interleukin 37 and Its Correlation With Autoantibodies and Disease Severity in Myasthenia Gravis Patients
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.
Read the detailed description
Follicular T cells play a vital role during autoimmune disorders. The enhanced number or activation of these cells results in hyperproliferation of autoreactive B cells and overproduction of antibodies. Interleukin-37 is a newly identified immune-suppressive factor. It acts as an inhibitor of inflammation and plays an important regulatory role in both innate and adaptive immune responses. In Myasthenia Gravis, Cluster of differentiation 4+ T cell is the dominant cellular source for Interleukin-37 production directed to T follicular helper and B cells .It represses cell proliferation and secretion of autoantibody indicating that Interleukin-37 is a critical regulatory factor. The immunosuppressive features of Interleukin 37 contributing to autoimmune diseases are important and still poorly investigated. For this reason, the present study is designed to detect the level of expression of Interleukin 37 in Myasthenia Gravis patients and its correlation with autoantibodies serum levels and disease severity.
- Conditions
- Myasthenia Gravis
- Being tested
- real time PCR , ELISA
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real time PCR , ELISADiagnostic test
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. Detection of autoantibodies to muscle specific kinase (MuSK) and low-density lipoprotein receptor-related protein 4 (LRP4) serum levels by ELISA
| Study group | Role | What they receive |
|---|---|---|
| Myasthenia Gravis cases | 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. Receives: Diagnostic Test: real time PCR , ELISA | |
| Healthy Control | 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. Receives: Diagnostic Test: real time PCR , ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression levels of Interleukin 37
change in the expression levels of Interleukin 37 gene in the Myasthenia Gravis patients relative to the healthy control.
Measured: a year
Secondary outcomes (1)
Autoantibodies detection
Correlation of the gene expression levels with muscle specific kinase (MuSK) and low-density lipoprotein receptor-related protein (LRP4) autoantibodies serum level.
Measured: a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Medhat Ahmed El Galaly, Assiut University
- Investigators
- Radwa Medhat, Dem, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301153
- Sponsor's protocol ID
- myasthenia1932022
- Status last verified
- Apr 2022
- First submitted
- 19 Mar 2022
- Last updated
- 3 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fichtner 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.
PubMed 32547535Lazaridis 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.
PubMed 32117321Crotty S. Follicular helper CD4 T cells (TFH). Annu Rev Immunol. 2011;29:621-63. doi: 10.1146/annurev-immunol-031210-101400.
PubMed 21314428King 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.
PubMed 18173374Liu 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.
PubMed 32111731
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression Levels of Interleukin 37 and Its Correlation With Autoantibodies and Disease Severity in Myasthenia Gravis Patients
- ClinicalTrials.gov ID
- NCT05301153
- Acronym / sponsor ID
- myasthenia1932022
- Conditions
- Myasthenia Gravis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Follicular T cells play a vital role during autoimmune disorders. The enhanced number or activation of these cells results in hyperproliferation of autoreactive B cells and overproduction of antibodies. Interleukin-37 is a newly identified immune-suppressive factor. It acts as an inhibitor of inflammation and plays an important regulatory role in both innate and adaptive immune responses. In Myasthenia Gravis, Cluster of differentiation 4+ T cell is the dominant cellular source for Interleukin-37 production directed to T follicular helper and B cells .It represses cell proliferation and secretion of autoantibody indicating that Interleukin-37 is a critical regulatory factor. The immunosuppressive features of Interleukin 37 contributing to autoimmune diseases are important and still poorly investigated. For this reason, the present study is designed to detect the level of expression of Interleukin 37 in Myasthenia Gravis patients and its correlation with autoantibodies serum levels and disease severity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myasthenia Gravis cases | – | Diagnostic Test: real time PCR , ELISA1. 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. |
| Healthy Control | – | Diagnostic Test: real time PCR , ELISA1. 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The estimated minimum required sample size is 84 cases (42 case in each group). sample size was calculated using G*power software 3.1.9.7. As this study aims to detect the large difference between the the group of Myasthenia Gravis patients relative to the healthy controls, so the calculation based on determining the large effect size. Main statistical test is two tailed t-test to detect difference between two groups . Effect size = 0.8 Alpha = 0.05 Power = 0.95 Allocation ratio = 1
Key inclusion criteria (2 listed)
- Clinical Diagnosis of Myasthenia Gravis.
- Willingness to sample collection.
Key exclusion criteria (4 listed)
- History of chronic psychiatric or neurological disorder other than Myasthenia Gravis that can produce weakness or fatigue.
- Severe systemic illness affecting life-expectancy ( chronic liver or kidney diseases).
- History of autoimmune diseases, connective tissue diseases, , or genetic diseases.
- Patients on large dosage of immune-suppressive treatment or Intravenous immunoglobulin in the recent 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real time PCR , ELISAReal-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. Detection of autoantibodies to muscle specific kinase (MuSK) and low-density lipoprotein receptor-related protein 4 (LRP4) serum levels by ELISA | Diagnostic test | Healthy Control, Myasthenia Gravis cases |
Primary outcome
Expression levels of Interleukin 37
Time frame: a year
change in the expression levels of Interleukin 37 gene in the Myasthenia Gravis patients relative to the healthy control.
1 secondary outcome
Autoantibodies detection
Time frame: a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Results publication: PubMed 32547535Fichtner 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.
- Results publication: PubMed 32117321Lazaridis 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.
- Results publication: PubMed 21314428Crotty S. Follicular helper CD4 T cells (TFH). Annu Rev Immunol. 2011;29:621-63. doi: 10.1146/annurev-immunol-031210-101400.
- Results publication: PubMed 18173374King 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.
- Results publication: PubMed 32111731Liu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radwa Medhat, Dem principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha Afifi, Prof (01006261108, nohaafifi2015@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression levels of Interleukin 37 (time frame: a year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05301153, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.