NCT07761026

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
116mo left

Started Mar 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Mar 2026Mar 2036

Study Start

First participant enrolled

March 19, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2036

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2036

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

10 years

First QC Date

August 4, 2026

Last Update Submit

August 7, 2026

Conditions

Keywords

myasthenia gravisautoimmune diseases of the nervous systemneuromuscular junction diseasespatient registriesnatural historylongitudinal studiesobservational studypatient-reported outcome measuresquality of lifeactivities of daily livingtreatment patternsmedication adherencetreatment burdenhealthcare utilizationdisease progressionreal-world data

Outcome Measures

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.

    through study completion, up to 10 years

Secondary Outcomes (2)

  • MG-QOL15r

    through study completion, up to 10 years

  • MGFA Clinical Classification (patient-reported proxy)

    through study completion, up to 10 years

Study Arms (1)

Myasthenia Gravis (MG)

Adults with confirmed diagnosis of MG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • Physician-confirmed diagnosis of myasthenia gravis (MG)
  • Willing and legally able to provide consent
  • Lives in the United States

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alira Health - Virtual/Remote Site - Can Be Completed 100% Online - All US Residents Accepted

Framingham, Massachusetts, 01702, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Myasthenia GravisAutoimmune Diseases of the Nervous SystemNeuromuscular Junction DiseasesMedication AdherenceDisease Progression

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesNervous System DiseasesNeurodegenerative DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Richard J Nowak, MD, MS

    Yale University

    STUDY CHAIR
  • Gary R Cutter, PhD

    University of Alabama at Birmingham

    STUDY DIRECTOR
  • Neelam Goyal, MD

    Stanford University

    STUDY DIRECTOR
  • Srikanth Muppidi, MD

    Stanford University

    STUDY DIRECTOR
  • Jared R Adams, MD, PhD

    Alira Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AXIS Patient Registry Team

CONTACT

President, Board of Directors, Autoimmune Neurology Alliance

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2026

First Posted

August 12, 2026

Study Start

March 19, 2026

Primary Completion (Estimated)

March 1, 2036

Study Completion (Estimated)

March 1, 2036

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant data may be made available to qualified researchers for approved research projects. Requests will be reviewed by the AXIS Registry Scientific Committee and/or other applicable scientific or governance bodies. Access will be subject to an approved research proposal, applicable data-use agreements, participant consent, privacy protections, and any legal, ethical, or contractual requirements. A data dictionary describing the shared variables will be provided with approved datasets. Direct identifiers will not be shared.

Shared Documents
STUDY PROTOCOL, ICF

Locations