Ravulizumab Treatment Outcomes in Patients With Generalized Myasthenia Gravis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-15

Study Completion Date

2029-12-31

Brief Summary

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

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Detailed Description

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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).

Conditions

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Myasthenia Gravis, Generalized

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ravulizumab

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

Ravulizumab

Intervention Type DRUG

Ravulizumab, concentrate for solution for infusion

Interventions

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Ravulizumab

Ravulizumab, concentrate for solution for infusion

Intervention Type DRUG

Other Intervention Names

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Ultomiris

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No