Ravulizumab Treatment Outcomes in Patients With Generalized Myasthenia Gravis (MG-ARCADIA)

AstraZeneca

Status: Enrolling

Conditions: Myasthenia Gravis, Generalized

Treatments: Drug: Ravulizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06909253

D9281R00004

Details and patient eligibility

About

The Polish multicentre observational (non-interventional) study aiming to collect data on the management and clinical outcomes of patients with gMG that received ravulizumab.

Full description

The Polish, prospective, multicenter, observational, cohort study designed to collect longitudinal data on the management and clinical outcomes of patients with gMG naive to complement inhibitors who received ravulizumab in the scope of routine clinical practice within the frames of National Drug Program (NDP) for up to 42 months (~ 6 months baseline and ~36 months follow-up).

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (aged ≥18 years) patients with gMG, naive to complement inhibitors, receiving ravulizumab treatment in the frames of NDP in Poland.
• Patients willing to participate in the study and signed Informed Consent Form (ICF).
• Vaccination against N. meningitidis

Exclusion criteria

• Those who plan to participate in gMG clinical trial on/after the date of first ravulizumab infusion through NDP.
• Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Trial design

50 participants in 1 patient group

Ravulizumab

Description:

Open-lable arm with gMG patients who received ravulizumab treatment in the frames of NDP in Poland.

Treatment:

Drug: Ravulizumab