Actively Recruiting
Ravulizumab Treatment Outcomes in Patients With Generalized Myasthenia Gravis (gMG) Naive to Complement Inhibitors Prospective Multicenter Non-interventional Study
Led by AstraZeneca · Updated on 2026-05-15
50
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to collect detailed information about how patients with generalized myasthenia gravis (gMG) who have not previously received complement inhibitors respond to ravulizumab treatment. The study is observational and takes place in multiple centers in Poland, focusing on patients treated within the National Drug Program (NDP). The study will follow patients for about 42 months, including a 6-month baseline period and a 36-month follow-up. Patients in this study are those who have started ravulizumab treatment as part of routine care under the NDP. This is an open-label study, meaning all participants receive ravulizumab and no placebo or comparison treatment is used. The treatment involves infusions of ravulizumab, a drug given by intravenous infusion, and the study will document how patients are managed and respond over time. Participants will be regularly assessed using various tools to measure their symptoms, daily living activities, quality of life, fatigue, mood, and work productivity. Key measurements include changes in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) score at 6, 12, 24, and 36 months. The study also monitors patient impressions of improvement and quality of life changes. Data collection includes questionnaires and clinical evaluations during the 42-month period to understand long-term outcomes and treatment effects.
CONDITIONS
Brief Title
Ravulizumab Treatment Outcomes in Patients With Generalized Myasthenia Gravis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (aged 65 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
You will not qualify if you...
- Planning to participate in a gMG clinical trial on or after the first ravulizumab infusion through NDP.
- Cognitive incapacity, unwillingness, or language barriers that prevent adequate understanding or cooperation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 42 months (~6 months baseline and ~36 months follow-up)
Participants receiving ravulizumab treatment in routine clinical practice are observed for management and clinical outcomes of generalized myasthenia gravis.
Regular visits according to routine clinical practice for up to 42 months
Trial Site Locations
Total: 13 locations
1
Research Site
Bydgoszcz, Poland
Actively Recruiting
2
Research Site
Gdansk, Poland
Actively Recruiting
3
Research Site
Katowice, Poland
Actively Recruiting
4
Research Site
Katowice, Poland
Not Yet Recruiting
5
Research Site
Krakow, Poland
Actively Recruiting
6
Research Site
Lodz, Poland
Actively Recruiting
7
Research Site
Lublin, Poland
Actively Recruiting
8
Research Site
Poznan, Poland
Withdrawn
9
Research Site
Poznan, Poland
Not Yet Recruiting
10
Research Site
Szczecin, Poland
Actively Recruiting
11
Research Site
Szczecin, Poland
Not Yet Recruiting
12
Research Site
Warsaw, Poland
Actively Recruiting
13
Research Site
Wroclaw, Poland
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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