Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
163 participants
OBSERVATIONAL
2021-10-31
2024-04-30
Brief Summary
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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.
Detailed Description
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The research project will consist of three work streams:
1. A one-off observational comparison of the immune profile of patients with different MG severity and in comparison to healthy controls.
2. A prospective observational study examining changes in lymphocyte subset, cytokine and complement profiles associated with clinical exacerbation of myasthenia gravis.
3. A prospective cohort study comparing lymphocyte subset, cytokine and complement profile with disease activity following B cell depletion for refractory myasthenia gravis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Stable Immunosuppressed
Acetylcholine repector antibody positvie myasthenia gravis, stable for two years on prednsiolone \<5mg/day and azathioprine or mycophenolate.
No interventions assigned to this group
Stable Non-immunosuppressed
Acetylcholine repector antibody positvie myasthenia gravis, stable for two years on ≤120mg pyridostigmine/day and no immunosuppression.
No interventions assigned to this group
Refractory
Acetylcholine repector antibody positvie myasthenia gravis, meeting the NHS England criteria for Rituximab
No interventions assigned to this group
Healthy Controls
No autoimmune disease or current solid organ or haematological malignancy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Are able to give valid written consent
* are aged between the ages of 18 and 80
Stable Immunosuppressed
* Have a diagnosis of AChR positive myasthenia gravis (can be ocular, bulbar or generalised)
* MGFA Post-intervention Status MM or better with no clinical relapse for 2 years
* On either azathioprine or MMF along with ≤5mg/day of prednisolone
* No prednisolone dose increase or decrease in past 12 months
* No increase in azathioprine or MMF dose for 2 years (allowing for cessation for up to 1 month)
Stable Non-Immunosuppressed
* have a diagnosis of AChR positive myasthenia gravis (can be ocular, bulbar or generalised)
* MGFA Post-intervention Status MM or better on only low-dose cholinesterase inhibitors (≤\<120 mg pyridostigmine/day) for over two years and ≤5mg/day of prednisolone for over two years.
* No prednisolone dose increase or decrease in past 12 months
Refractory
* have a diagnosis of AChR positive myasthenia gravis (can be ocular, bulbar or generalised)
* have been deemed eligible to be refractory to standard treatment and eligible for rituximab as per the NHS England criteria.
Exclusion Criteria
* Co-existing autoimmune condition for which azathioprine or mycophenolate mofetil are treatments (e.g. inflammatory bowel disease, rheumatoid arthritis, neuromyotonia)
* Currently undergoing treatment for solid organ or haematological malignancy, or previous thymoma
* Clinical frailty scale ≥6
18 Years
80 Years
ALL
Yes
Sponsors
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Northern Care Alliance NHS Foundation Trust
OTHER
Walton Centre NHS Foundation Trust
OTHER
Oxford University Hospitals NHS Trust
OTHER
University College London Hospitals
OTHER
University Hospital Birmingham NHS Foundation Trust
OTHER
Imperial College Healthcare NHS Trust
OTHER
Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
King's College Hospital NHS Trust
OTHER
Nottingham University Hospitals NHS Trust
OTHER
University Hospital Southampton NHS Foundation Trust
OTHER
Cardiff University
OTHER
University of Manchester
OTHER
Responsible Party
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Katherine Dodd
Neurology Clinical Research Fellow and PhD Student
Principal Investigators
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Katherine Dodd, MBChB MRCP
Role: PRINCIPAL_INVESTIGATOR
University of Manchester
Central Contacts
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Other Identifiers
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NHS001843
Identifier Type: -
Identifier Source: org_study_id