A Prospective Cohort Study of Myasthenia Gravis in China

NCT ID: NCT06006832

Last Updated: 2024-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-20

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myasthenia Gravis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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maintenance steroid therapy group

Maintaining low-dose oral steroids

Steroid Drug

Intervention Type DRUG

Maintaining low-dose oral steroids

immunosuppresants withdrawal group

Withdraw all immunosuppresants

Withdraw all immunosuppresants

Intervention Type OTHER

Withdraw all immunosuppresants

Interventions

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Steroid Drug

Maintaining low-dose oral steroids

Intervention Type DRUG

Withdraw all immunosuppresants

Withdraw all immunosuppresants

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuzhou Guan

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuzhou Guan

Role: CONTACT

8610-69155817

Facility Contacts

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Bin Peng

Role: primary

8610-69155817

Other Identifiers

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K2009

Identifier Type: -

Identifier Source: org_study_id

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