Myasthenia Gravis Foundation of America Global MG Patient... | NCT06617741

Studies
Myasthenia Gravis Foundation of America Global MG Patient Registry

NCT06617741

Sponsor

Myasthenia Gravis Foundation of America

Status

Recruiting

Last Update Posted

Sep 27, 2024Actual

Enrollment

3,800Estimated

Phase

Not provided

Conditions

Myasthaenia Gravis
Myasthenia
Myasthenia Gravis Associated with Thymoma
Myasthenia Gravis Crisis
Myasthenia Gravis Exacerbations
Myasthenia Gravis Generalised
Myasthenia Gravis with Exacerbation (Disorder)
Myasthenia Gravis, Adult Form
Myasthenia Gravis, Generalized
Myasthenia Gravis, Ocular
Myasthenia Gravis, Thymectomy
Myasthenia Gravis
Myasthenia Gravis, MuSK

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 12, 2013Actual

Primary Completion Date

Sep 19, 2029Estimated

Completion Date

Sep 19, 2029Estimated

First Submitted Date

Sep 26, 2024

First Submission Date that Met QC Criteria

Sep 26, 2024

First Posted Date

Sep 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2024

Last Update Posted Date

Sep 27, 2024Actual

Name	Class
Alira Health	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to learn about the experiences of people living with Myasthenia Gravis (MG) in the United States. The main questions it aims to answer are:

How and when are people with MG diagnosed?
What are the most common symptoms associated with MG?
What treatments are being used to treat MG?
What are the impacts of MG on activities of daily living, employment and quality of life?
What are the experiences with exacerbation, hospitalization and healthcare access for people with MG? Participants will answer a survey to enroll in the study, and be invited to fill out an update survey twice a year.

Detailed Description

This is a longitudinal, observational, patient reported registry.

Conditions Module

Conditions

Myasthaenia Gravis
Myasthenia
Myasthenia Gravis Associated with Thymoma
Myasthenia Gravis Crisis
Myasthenia Gravis Exacerbations
Myasthenia Gravis Generalised
Myasthenia Gravis with Exacerbation (Disorder)
Myasthenia Gravis, Adult Form
Myasthenia Gravis, Generalized
Myasthenia Gravis, Ocular
Myasthenia Gravis, Thymectomy
Myasthenia Gravis
Myasthenia Gravis, MuSK

Keywords

myasthenia
patient registry
MGFA
Myasthenia Gravis Foundation of America
myasthenia gravis

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

15 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,800Estimated

Label	Type	Description	Intervention Names
Participants		Those with Myasthenia Gravis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnosis of MG	Whether the patient has a confirmed MG diagnosis.	At enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age over 18
positive MG diagnosis

Exclusion Criteria:

age under 18
misdiagnosed with MG

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Participants with access to a mobile device or desktop computer with internet connection are eligible to participate in this study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
National Director, Patient Registry	Contact	8005415454		gmvalo@myasthenia.org

Overall Officials

Name	Affiliation	Role
Patient Registry PI	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Myasthenia Gravis Foundation of America	Recruiting	Westborough	Massachusetts	01581	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Direct access to IPD is not widely shared. However, analysis of the data can be facilitated through collaboration with Alira Health.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D009157	Myasthenia Gravis

Ancestor Terms

ID	Term
D020361	Paraneoplastic Syndromes, Nervous System
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010257	Paraneoplastic Syndromes
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D019636	Neurodegenerative Diseases
D020511	Neuromuscular Junction Diseases
D009468	Neuromuscular Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases