Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-24 @ 7:17 PM
NCT ID:
NCT05095103
Eligibility Criteria:
Inclusion Criteria:
* All participants:
* 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 for all participants:
* Are unable to give valid consent
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05095103
Study Brief:
Protocol Section:
NCT05095103