Efgartigimod in IVIG Dependent Myasthenia Gravis Patients
ConditionMyasthaenia Gravis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorClinique Neuro-Outaouais
About this trial
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.
Eligibility criteria
Qualifiers
1. Signed informed consent. 2. Age 18-80 years 3. Acetylcholine receptor antibody positive, myasthenia gravis patients, with stable disease for the past four or more months. Stable disease is defined as no change in dosage or interval in IVIG treatments and without any significant change in clinical status.
Disqualifiers
1. Patients with previous rituxan or eculizumab treatment or plasma exchange within the past six months 2. Patients with previous thymectomy within the past 3months 3. Patients that have active Hepatitis B, are seropositive for Hepatitis C or HIV or have latent, untreated or active TB or any other significant active infection 4. Patients that have at screening a serum IgG less than 6.0gm/L or a history of chronic hypogammaglobulinemia from any cause.
Trial design
Treatments tested in this trial
- efgartigimod administration
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Clinique Neuro-Outaouais
Lead sponsor
argenx
Collaborator
Source ClinicalTrials.gov