Actively Recruiting
A Multicenter, Prospective, Observational Study to Evaluate Corticosteroid Reduction in Elderly Patients with Generalized Anti-AChR Myasthenia Gravis Treated with IV or SC Efgartigimod
Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-09-24
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Generalized Myasthenia Gravis (gMG) is a rare autoimmune disorder that causes muscle weakness and fatigue due to antibodies that affect nerve-muscle connections. This condition mainly affects elderly patients who often face persistent symptoms and side effects from treatments like corticosteroids, which can increase risks such as infections, heart problems, and other chronic diseases. Researchers are evaluating efgartigimod, a new drug that targets harmful antibodies, to see if it can help reduce corticosteroid use and improve symptoms and quality of life in elderly gMG patients. Participants in this study will receive efgartigimod either through intravenous (IV) infusion or subcutaneous (SC) injection. This observational study will monitor patients who are already using high or intermediate doses of corticosteroids and have developed related health issues. The study aims to assess how efgartigimod affects corticosteroid dosage and patient health over a 12-month period. During the study, participants will attend scheduled visits for assessments including physical exams, laboratory tests, and monitoring of corticosteroid doses and side effects. Researchers will measure changes in corticosteroid use, muscle strength, comorbidities, and overall health. The study will also track quality of life and safety outcomes. Participation will last at least 12 months, with evaluations focusing on corticosteroid dose reduction and health improvements.
CONDITIONS
Brief Title
Evaluate the Benefit of Corticoid Sparing in Elderly With Generalized AntiRAch Myasthenia Gravis Treated With IV or SC Efgartigimod
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 65 years or older
- Diagnosed with generalized Myasthenia Gravis confirmed by physical exam and positive Anti-AChR antibodies
- Meets clinical criteria for generalized MG class IIa, IIb, IIIa, or IIIb
- Suitable for efgartigimod treatment
- MG-ADL score of 2 or higher
- Treated with high (>50mg daily) or intermediate (20-50mg daily) dose oral corticosteroids and stable on other treatments for at least 3 months
- Developed at least one corticosteroid-related comorbidity such as type 2 diabetes, hypertension, overweight, sleep disorders, or irritability
- Able to understand and provide written informed consent
- Willing and able to comply with study visits, treatment, tests, contraceptive guidance, and procedures
- Affiliated with a European social security system
You will not qualify if you...
- Current mental health condition or cognitive impairment affecting study compliance or understanding (MMSE score below 28)
- Any illness or condition that might affect study results or increase risk with study drug
- Ongoing cancer except fully treated skin or cervical carcinoma
- Active uncontrolled bacterial, viral, or fungal infection
- Recent vaccination with live or live-attenuated vaccines within 6 weeks
- Previous treatment with anti-complement, anti-FcRN, anti-CD20 therapies, or plasma exchange within specified wash-out periods
- End-stage disease or other conditions preventing evaluation or treatment
- Legal protection status preventing study participation according to French Public Health Code
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants receive efgartigimod, administered either intravenously or subcutaneously, to manage generalized Anti-AChR Myasthenia Gravis while reducing corticosteroid use.
Trial Site Locations
Total: 1 location
1
CHU de Nice
Nice, Alpes-Maritimes, France, 06000
Actively Recruiting
Research Team
S
Sabrina SACCONI, pu-ph
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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