A Prospective Cohort Study of Myasthenia Gravis in China

January 10, 2024 updated by: Peking Union Medical College Hospital

Clinical Characteristics, Prognosis and Biomarkers of Myasthenia Gravis: a Prospective Cohort Study in China

The goal of this prospective cohort study is to investigate long-term therapeutic strategies for myasthenia gravis (MG) and identify potential biomarkers. The main questions it aims to answer are:

  1. Whether low-dose oral steroids may lead to a reduction in the recurrence rate among patients with MG.
  2. To identify potential biomarkers that can predict disease progression and prognosis.

This study recruits well-controlled patients with MG. Based on patient preferences and considerations such as coexisting conditions (e.g., uncontrolled hypertension, diabetes, severe osteoporosis, obesity), the participants will be non-randomly divided into two groups: a maintenance steroid therapy group and a withdrawal group (withdraw all immunosuppresants). Subsequently, these groups of patients will undergo long-term follow-up assessments.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with myasthenia gravis who can completed long-term follow-up at PUMCH.

Description

Inclusion Criteria:

  • 1: Attended the outpatient department of neurology of PUMCH from 9/30/2022 to 9/30/2024.
  • 2: Diagnosed as myasthenia gravis.
  • 3: Follow-up time at PUMCH>6 months.
  • 4: The patient understood and signed the informed consent form.

Exclusion Criteria:

  • 1: Comorbidities with other conditions that cause skeletal muscle weakness make the clinical symptoms difficult to assess
  • 2: Records related to comorbidities and medications were not available at baseline and during follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
maintenance steroid therapy group
Maintaining low-dose oral steroids
Drug: Steroid Drug
Maintaining low-dose oral steroids
immunosuppresants withdrawal group
Withdraw all immunosuppresants
Other: Withdraw all immunosuppresants
Withdraw all immunosuppresants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse of myasthenia gravis
Time Frame: Within two years after recruitment
One of the following three is met: (1) MGFA Postintervention Status: failure to maintain MMS (minimal manifestations status) or better. (2) Myasthenia gravis activities of daily living (MG-ADL) score ≥ 3; (3) Re-administration of cholinesterase inhibitors was required after achieving Complete Stable Remission (CSR) on the MGFA Postintervention Status.
Within two years after recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of relapse
Time Frame: Within two years after recruitment
The time between recruitment and relapse of MG.
Within two years after recruitment
Change of MG assessment scales at relapse
Time Frame: Within two years after recruitment
Change of MG assessment scales at relapse, including MGFA PIS (Postintervention Status), MG-ADL (myasthenia gravis activities of daily living), QMG (Quantitative Myasthenia gravis) and MGC (Myasthenia gravis composite).
Within two years after recruitment
Adverse events of steroids
Time Frame: Within two years after recruitment
Using CTCAE (Common Terminology Criteria for Adverse Events) to assess Adverse events.
Within two years after recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Yuzhou Guan, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K2009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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