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AXIS MG Patient Registry

ConditionsMyasthenia Gravis (MG)Myasthenia Gravis, GeneralizedMyasthenia Gravis, OcularMyasthenia Gravis CrisisMyasthenia Gravis Associated With ThymomaMyasthenia Gravis ExacerbationsMyasthenia Gravis GeneralisedMyasthenia Gravis GeneralizedMyasthenia Gravis, ThymectomyMyasthenia GravisMyasthenia Gravis, MuSKAChR Myasthenia GravisAChR-Ab Seropositive Generalized Myasthenia GravisMGMG - Myasthenia Gravis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAutoimmune Neurology Alliance

About this trial

The goal of the AXIS Autoimmune Neurology Registry is to learn about the experiences of adults living with autoimmune neurological disorders, starting with myasthenia gravis (MG), over time.

The main questions the registry aims to answer are:

* How do symptoms, daily functioning, and quality of life change over time? * What treatments do participants use, and how are these treatments related to their symptoms and health? * What challenges do participants experience with treatment, including side effects, treatment burden, missed doses, and access to care?

Participants will:

* Join the registry and complete an enrollment survey (online or through a mobile app) * Complete a brief online survey about their MG approximately once a month * Provide information that can help confirm their MG diagnosis * Optionally, share their medical records with the research team

This is an observational study. The registry will not assign treatments or ask participants to change their medical care. Information collected through the registry may help researchers better understand MG and improve future research and care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Physician-confirmed diagnosis of myasthenia gravis (MG)

Willing and legally able to provide consent

Lives in the United States

Disqualifiers

Unwilling or unable to provide consent or comprehend and complete questionnaires

Cognitively impaired adults/unable to comprehend or understand the consent or overall study information

Trial population

Adults in the United States with a healthcare provider diagnosis of myasthenia gravis will be recruited from the community. Participants may be identified through healthcare providers, patient advocacy and research organizations, existing patient communities or registries, digital and social media outreach, and direct communications. The registry is decentralized, so participants may enroll and complete study activities remotely from locations across the United States.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Myasthenia Gravis (MG)

Trial outcomes

Primary outcomes

1

MG-ADL

The Myasthenia Gravis Activities of Daily Living (MG-ADL) profile assesses the severity of myasthenia gravis symptoms during the previous week. Participants rate 8 activities: talking, chewing, swallowing, breathing, brushing teeth or combing hair, rising from a chair, double vision, and eyelid droop. Each item is scored from 0 to 3. Item scores are summed for a total score ranging from 0 to 24. A score of 0 indicates no reported impairment, and higher scores indicate greater symptom severity and functional impairment.

Time frame
through study completion, up to 10 years

Secondary outcomes

1

MG-QOL15r

The revised 15-item Myasthenia Gravis Quality of Life (MG-QOL15r) questionnaire assesses how myasthenia gravis affected the participant's life during the previous 4 weeks. Participants rate 15 items covering physical functioning, social activities, work, family responsibilities, mobility, personal care, emotional well-being, and enjoyment of activities. Each item is scored from 0 to 2. Item scores are summed for a total score ranging from 0 to 30. A score of 0 indicates no reported effect on quality of life, and higher scores indicate a greater negative effect of myasthenia gravis on quality of life.

Time frame
through study completion, up to 10 years
2

MGFA Clinical Classification (patient-reported proxy)

A patient-reported proxy for the Myasthenia Gravis Foundation of America Clinical Classification, based on the participant's MG symptoms at their worst during the past month. Participants select 1 of 5 ordered categories: Class I, weakness limited to the eye or eyelid muscles; Class II, mild weakness affecting other muscles; Class III, moderate weakness affecting other muscles; Class IV, severe weakness affecting other muscles; or Class V, use of a breathing tube, except when planned for surgery. Eye or eyelid weakness may also occur in Classes II-IV. Higher classes indicate more severe MG. This proxy is not a clinician-assessed classification.

Time frame
through study completion, up to 10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Autoimmune Neurology Alliance

Lead sponsor

Alira Health

Collaborator

Source ClinicalTrials.gov
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