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Recruiting NCT06909253

Ravulizumab Treatment Outcomes in Patients With Generalized Myasthenia Gravis

Conditions: Myasthenia Gravis, Generalized

Sponsor: AstraZeneca

trial.available_in: БГ
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.
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).
Who can participate
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.
Interventions
Ravulizumab
DRUG
Locations 14
Poland (14)
Research Site
Bydgoszcz
Research Site
Gdansk
Research Site
Katowice
Research Site
Katowice
NOT_YET_RECRUITING
Research Site
Krakow
Research Site
Lodz
Research Site
Lublin
Research Site
Poznan
WITHDRAWN
Research Site
Poznan
NOT_YET_RECRUITING
Research Site
Szczecin
Research Site
Szczecin
NOT_YET_RECRUITING
Research Site
Warsaw
Research Site
Warsaw
NOT_YET_RECRUITING
Research Site
Wroclaw
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
15.05.2025
Completion date
31.12.2029
Registry ID
NCT06909253
Source
clinicaltrials.gov
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