Observational study on ravulizumab for generalized myasthenia gravis
Ravulizumab Treatment Outcomes in Patients With Generalized Myasthenia Gravis (gMG) Naive to Complement Inhibitors. Prospective, Multicenter, Non-interventional Study (MG-ARCADIA).
This study is looking at how well ravulizumab works for people with generalized myasthenia gravis over three years to see how it helps their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | ravulizumab |
| Locations | 14 sites (Bydgoszcz and 13 other locations) |
| Trial ID | NCT06909253 on ClinicalTrials.gov |
What this trial studies
This Polish multicenter observational study aims to collect data on the management and clinical outcomes of patients with generalized myasthenia gravis (gMG) who are receiving ravulizumab treatment. The study will follow patients for up to 42 months, including a 6-month baseline period and 36 months of follow-up, to gather longitudinal data on their health outcomes. It focuses on patients who are naive to complement inhibitors and are treated under the National Drug Program in Poland.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with generalized myasthenia gravis who have not previously received complement inhibitors.
Not a fit: Patients who are currently participating in other clinical trials for generalized myasthenia gravis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of ravulizumab for patients with generalized myasthenia gravis.
How similar studies have performed: Other studies have shown promising results with similar treatments for generalized myasthenia gravis, indicating potential for success in this observational study.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bydgoszcz and 13 other locations
- Research Site — Bydgoszcz, Poland (Recruiting)
- Research Site — Gdansk, Poland (Recruiting)
- Research Site — Katowice, Poland (Recruiting)
- Research Site — Katowice, Poland (Not_yet_recruiting)
- Research Site — Krakow, Poland (Recruiting)
- Research Site — Lodz, Poland (Recruiting)
- Research Site — Lublin, Poland (Recruiting)
- Research Site — Poznan, Poland (Withdrawn)
- Research Site — Poznan, Poland (Not_yet_recruiting)
- Research Site — Szczecin, Poland (Recruiting)
- Research Site — Szczecin, Poland (Not_yet_recruiting)
- Research Site — Warsaw, Poland (Recruiting)
- Research Site — Warsaw, Poland (Not_yet_recruiting)
- Research Site — Wroclaw, Poland (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.