A Prospective Cohort Study of Myasthenia Gravis in China

Myasthenia Gravis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06006832
• Other study ID #: K2009
• Status: Recruiting
• Start date: August 20, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: August 2023
• Source: Peking Union Medical College Hospital
• Contact: Yuzhou Guan
• Phone: 8610-69155817
• Email: guanyz001[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis

Intervention

Drug:
• Steroid Drug
Maintaining low-dose oral steroids

Other:
• Withdraw all immunosuppresants
Withdraw all immunosuppresants

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse of myasthenia gravis	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	Time of relapse	The time between recruitment and relapse of MG.	Within two years after recruitment
Secondary	Change of MG assessment scales at relapse	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
Secondary	Adverse events of steroids	Using CTCAE (Common Terminology Criteria for Adverse Events) to assess Adverse events.	Within two years after recruitment