A Prospective Cohort Study of Myasthenia Gravis in China

Recruiting

• Conditions: Myasthenia Gravis
• Interventions: Drug: Steroid Drug; Other: Withdraw all immunosuppresants

• Registration Number: NCT06006832
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-17
• Study Start: 2023-08-20
• Study First Posted: 2023-08-23
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 202

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
maintenance steroid therapy group	Steroid Drug	Maintaining low-dose oral steroids
immunosuppresants withdrawal group	Withdraw all immunosuppresants	Withdraw all immunosuppresants

Primary Outcome Measures

Name	Time	Method
Relapse of myasthenia gravis	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.

Secondary Outcome Measures

Name	Time	Method
Adverse events of steroids	Within two years after recruitment	Using CTCAE (Common Terminology Criteria for Adverse Events) to assess Adverse events.
Time of relapse	Within two years after recruitment	The time between recruitment and relapse of MG.
Change of MG assessment scales at relapse	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).

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China