A Prospective Cohort Study of Myasthenia Gravis in China

NCT06006832 | Recruiting

• 1 other identifier: K2009
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

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

Conditions

Myasthenia Gravis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time of relapse

  Within two years after recruitment

• Change of MG assessment scales at relapse

  Within two years after recruitment

• Adverse events of steroids

  Within two years after recruitment

Study Arms (2)

maintenance steroid therapy group

Maintaining low-dose oral steroids

Drug: Steroid Drug

immunosuppresants withdrawal group

Withdraw all immunosuppresants

Other: Withdraw all immunosuppresants

Interventions

Steroid Drug DRUG

Maintaining low-dose oral steroids

maintenance steroid therapy group

Withdraw all immunosuppresants OTHER

Withdraw all immunosuppresants

immunosuppresants withdrawal group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood of each participant at each visit.

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yuzhou Guan

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuzhou Guan

CONTACT

8610-69155817; guanyz001@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: August 20, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 12, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)