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NCT Number: NCT06006832

A Prospective Cohort Study of Myasthenia Gravis in China

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Bin Peng

CONTACT

[email protected]

8610-69155817

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Steroid Drug

Drug

Maintaining low-dose oral steroids

Withdraw all immunosuppresants

Other

Withdraw all immunosuppresants

Primary outcomes

  1. Relapse of myasthenia gravis

    Time frame: 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 outcomes

  1. Time of relapse

    Time frame: Within two years after recruitment

    The time between recruitment and relapse of MG.

  2. Change of MG assessment scales at relapse

    Time frame: 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).

  3. Adverse events of steroids

    Time frame: Within two years after recruitment

    Using CTCAE (Common Terminology Criteria for Adverse Events) to assess Adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuzhou Guan

CONTACT

[email protected]

8610-69155817

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 23, 2023
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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