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Trial Title:
A Prospective Cohort Study of Myasthenia Gravis in China
NCT ID:
NCT06006832
Condition:
Myasthenia Gravis
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Steroid Drug
Description:
Maintaining low-dose oral steroids
Arm group label:
maintenance steroid therapy group
Intervention type:
Other
Intervention name:
Withdraw all immunosuppresants
Description:
Withdraw all immunosuppresants
Arm group label:
immunosuppresants withdrawal group
Summary:
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.
Criteria for eligibility:
Study pop:
Patients with myasthenia gravis who can completed long-term follow-up at PUMCH.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Bin Peng
Phone:
8610-69155817
Email:
pumchkyc@163.com
Start date:
August 20, 2023
Completion date:
September 30, 2026
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06006832
