Ravulizumab Treatment Outcomes in Patients With Generalized Myasthenia Gravis

AstraZeneca50 enrolled

Overview

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

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Myasthenia Gravis, Generalized

Interventions

RavulizumabDRUG

Ravulizumab, concentrate for solution for infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (14)

Research Site

Bydgoszcz, Poland

RECRUITING

Research Site

Gdansk, Poland

RECRUITING

Outcomes

Primary Outcomes

Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score

Time frame: at 6 month

Secondary Outcomes

Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score

Time frame: at month 12, 24, 36

Change from baseline in MG-ADL subcomponent scores

Subcomponent scores - bulbar, limbs, respiratory, and ocular