An observational study in Myasthenia Gravis, sponsored by University of Manchester. Status unknown. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-27.
Sponsored by University of Manchester · Observational
The investigators aim to better describe the immune profile in myasthenia gravis (MG), including lymphocyte subset, cytokine and complement profiles; how they differ between patients of different severity, at times of disease exacerbation, and with different immunosuppressive treatments. The investigators hope to build a clearer picture of how different immune measures vary in MG, contributing to the understanding of the patho[physiology of the disease, and working towards a biomarker that might help clinicians optimise an individual's treatment.
the investigators aim to take into account the heterogeneity of MG by taking into account age of onset of MG (early vs late onset) and focussing on acetylcholine receptor antibody (AChR) positive, non-thymomatous MG aged 18-80.
This study is designed to confirm and refine the knowledge around these changes in the immune profile, including lymphocyte subsets, and complement analysis, between different subgroups of patients with MG of different severity, different levels of immunosuppressive treatment, and at different time points in the disease course, ensuring these are put into the context of the patient's disease subtype (late-onset (LOMG) vs early-onset (EOMG)). This should enable us to understand more about the underlying immune changes in MG, how they relate to disease activity or severity, how this is impacted upon by immunosuppression, and guide us towards a markers for disease severity and effective immunosuppression that could be used in clinical practice, and help guide treatment decisions. One of the challenges in studying patients with MG with the relatively low prevalence of the condition, meaning it can be difficult to recruit large enough numbers of patients; the investigators will work with other tertiary neurology centres throughout England in order to meet recruitment targets.
The research project will consist of three work streams:
324 studies on the registry are indexed under Myasthenia Gravis; 146 are open to participants now.
This study's planned enrollment of 163 is above the median of 140 across 104 observational studies indexed under Myasthenia Gravis.
Browse Myasthenia Gravis studies →University of Manchester is the lead sponsor of 194 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Acetylcholine receptor antibody positive myasthenia gravis
Stable Immunosuppressed
Stable Non-Immunosuppressed
Refractory
Exclusion Criteria for all participants:
Acetylcholine repector antibody positvie myasthenia gravis, stable for two years on prednsiolone \<5mg/day and azathioprine or mycophenolate.
Acetylcholine repector antibody positvie myasthenia gravis, stable for two years on ≤120mg pyridostigmine/day and no immunosuppression.
Acetylcholine repector antibody positvie myasthenia gravis, meeting the NHS England criteria for Rituximab
No autoimmune disease or current solid organ or haematological malignancy.
Primary outcome work stream 1
Difference in CD19 count between cohorts
Time frame: Baseline
Primary outcome work stream 2
● CD27 frequency (% of peripheral blood mononuclear cells) at clinical exacerbation of MG compared to when that patient was clinically stable.
Time frame: Relapse within 18 months of recrutiment
Primary outcome work stream 3
● CD27+ frequency (% of peripheral blood mononuclear cells) in MG patients who are symptomatic compared to those who are asymptomatic 12 months following B cell depletion.
Time frame: 12 months after B cell depletion
MG Composite Score
Time frame: Baseline, at any clinical relapse within 18 months, 3,6 months after relapse in stable groups or 4 weeks, 6 and 12 months post rituximab in refractory groups,
MGFA - Post Intervention status
Time frame: Baseline, at any clinical relapse within 18 months, 3,6 months after relapse in stable groups or 4 weeks, 6 and 12 months post rituximab in refractory groups
MG QOL-15r
Time frame: Baseline, at any clinical relapse within 18 months, 3,6 months after relapse in stable groups or 4 weeks, 6 and 12 months post rituximab in refractory groups
Acetylcholine receptor antibody titre
Time frame: Baseline, at any clinical relapse within 18 months, 3,6 months after relapse in stable groups or 4 weeks, 6 and 12 months post rituximab in refractory groups
Lymphocyte Count
Time frame: Baseline, at any clinical relapse within 18 months, 3,6 months after relapse in stable groups or 4 weeks, 6 and 12 months post rituximab in refractory groups
Number of relapses requiring hospital admission or rescue therapy
Time frame: Baseline, at any clinical relapse within 18 months, 3,6 months after relapse in stable groups or 4 weeks, 6 and 12 months post rituximab in refractory groups
Average daily dose of prednisolone over the three months prior to review
Time frame: Baseline, at any clinical relapse within 18 months, 3,6 months after relapse in stable groups or 4 weeks, 6 and 12 months post rituximab in refractory groups
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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University of Manchester