MYASTEN: Ocular Mysathenia Gravis Generalization

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Completed

CT.gov ID

NCT04667650

Collaborator

(none)

151

Enrollment

Location

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Secondary ocular myasthenia gravis (OMG) generalization represents a pejorative evolution and no validated generalization prevention strategy exists. The aim of this observational study was to determine the percentage of patients with OMG generalization and identify factors predictive of that pejorative evolution. Data from patients with OMG registered in the Fondation Hospital A. de Rothschild database between January 1990 and January 2017 were collected. Among the 183 patients registered in this database, 151 patients with available informations were analyzed.

Condition or Disease	Intervention/Treatment	Phase
Ocular Myasthenia Gravis	Other: Use of nomogram for predictions of Ocular Mysathenia Gravis generalization

Study Design

Study Type:

Observational

Actual Enrollment :

151 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Use of Nomogram for Predictions of Ocular Mysathenia Gravis Generalization

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jan 1, 2020

Outcome Measures

Primary Outcome Measures

Time to myasthenia gravis generalization [1 year]
Kaplan-meier survival estimations, descriptive and multivariate Cox model analyses were computed (age at onset, first year anti-acetylcholine receptor antibody positivity, electromyogram decrement, steroid use).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with OMG diagnosis and its generalization who consulted between January 1990 to January 2017 at Fondation Hospital Adolphe de Rothschild and registered in the database

Exclusion Criteria:

OMG differential diagnoses

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Antoine GUEGUEN	Paris		France

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amélie Yavchitz, Dr Amélie Yavchitz, Fondation Ophtalmologique Adolphe de Rothschild

ClinicalTrials.gov Identifier:

NCT04667650

Other Study ID Numbers:

CE_20161027_22_AGN

First Posted:

Dec 16, 2020

Last Update Posted:

Dec 16, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myasthenia Gravis

Study Results

No Results Posted as of Dec 16, 2020