Actively Recruiting
Efgartigimod in IVIG Dependent Myasthenia Gravis Patients
Led by Clinique Neuro-Outaouais · Updated on 2025-07-29
30
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
C
Clinique Neuro-Outaouais
Lead Sponsor
A
argenx
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is an open label, single center, prospective, 26 weeks study with descriptive analysis where IVIG is replaced by efgartigimod therapy. MG-ADL and MGQOL evaluations will occur weekly throughout the study to week 26.
CONDITIONS
Official Title
Efgartigimod in IVIG Dependent Myasthenia Gravis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age between 18 and 80 years
- Acetylcholine receptor antibody positive myasthenia gravis patients with stable disease for at least four months
- No change in IVIG dosage or frequency during stable disease
- No changes or additions to non-steroidal immunosuppressive therapies in the past six months
- No changes or additions to corticosteroid therapy in the past three months
- Myasthenia gravis diagnosis supported by abnormal neurotransmission test or improvement with acetylcholinesterase inhibitors
- Receiving regular chronic IVIG treatments for myasthenia gravis for one year or more
You will not qualify if you...
- Previous rituxan, eculizumab treatment, or plasma exchange within the past six months
- Thymectomy within the past three months
- Active hepatitis B, seropositive for hepatitis C or HIV, latent untreated or active tuberculosis, or other significant active infections
- Serum IgG less than 6.0 gm/L at screening or history of chronic hypogammaglobulinemia
- Pregnant or planning to become pregnant within six months
- Severe renal impairment (eGFR less than 30 ml/min)
- Investigator's judgment that participation is not appropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinique Neuro-Outaouais
Gatineau, Quebec, Canada, J8Y1W2
Actively Recruiting
Research Team
F
François Jacques, Doctor
CONTACT
V
Victorine Sikati Foko, Nurse
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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