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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • efgartigimod administration

    Drug

    efgartigimod infusion

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

MG-ADL

The percentage of patients who do not experience, at any time during the study, a 2 or more-point deterioration from their averaged baseline MG-ADL score that is sustained for a period of 4 or more consecutive weeks. (stable or improved patients)

Time frame
a sustained decrease persistent for at least 4 consecutive weeks over the 26 week period

Secondary outcomes

1

QMG

The percentage of patients who do not experience, at any time during the study, a 3 or more-point deterioration from their baseline QMG score that is sustained for a period of 4 or more consecutive weeks. (stable or improved patients)

Time frame
those who experience a sustained decrease for 4 consecutive weeks during the 26 week period
2

MGQOL

The change in group, mean MGQOL score from the averaged baseline to the week 26 end of study visit.

Time frame
during the whole study period of 26 weeks
3

incidence of patients who are still receiving efgartigimod by the end of the 26 weeks

incidence of patients who are still receiving efgartigimod by the end of the 26 weeks

Time frame
for the duration of the 26 week study

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinique Neuro-Outaouais

Lead sponsor

argenx

Collaborator

Source ClinicalTrials.gov
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