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Ocular Mysathenia Gravis Generalization (MYASTEN)

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ClinicalTrials.gov Identifier: NCT04667650
Recruitment Status : Completed
First Posted : December 16, 2020
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Amélie Yavchitz, Fondation Ophtalmologique Adolphe de Rothschild

Study Description
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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
Ocular Myasthenia Gravis Other: Use of nomogram for predictions of Ocular Mysathenia Gravis generalization

Study Design
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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 : January 2017
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Use of nomogram for predictions of Ocular Mysathenia Gravis generalization
    The outcome measure was time to Myasthenia gravis generalization. The explanatory variables were age at onset, sex, first-year anti-acetylcholinereceptor antibody positivity, repetiting nerve stimulation showing electromyogram decrement and steroid use. Kaplan-Meier survival estimations, descriptive and multivariate Cox model analyses were computed. A nomogram combining explanatory vraiables was used to establish a score to predict the probability of OMG generalization.

Outcome Measures
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Primary Outcome Measures :
  1. Time to myasthenia gravis generalization [ Time Frame: 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
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04667650


Locations
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France
Antoine GUEGUEN
Paris, France
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
More Information
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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: December 16, 2020    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myasthenia Gravis
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases