An observational study in Myasthenia Gravis, Generalized, sponsored by AstraZeneca. Recruiting at 11 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by AstraZeneca · Observational
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).
324 studies on the registry are indexed under Myasthenia Gravis; 146 are open to participants now.
This study's planned enrollment of 50 is below the median of 140 across 104 observational studies indexed under Myasthenia Gravis.
Browse Myasthenia Gravis studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult (aged ≥18 years) patients with gMG, naive to complement inhibitors, receiving ravulizumab treatment within the frames of NDP in Poland.
Exclusion Criteria:
Open-lable arm with gMG patients who received ravulizumab treatment in the frames of NDP in Poland.
Drug: Ravulizumab
Ravulizumab, concentrate for solution for infusion
Also known as: Ultomiris
Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score
Time frame: at 6 month
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
Time frame: at month 6, 12, 24, 36
Change from baseline in Myasthenia Gravis (MG) composite scale
Time frame: at month 6, 12, 24, 36
Proportion of patients who achieved response
Response - an improvement of ≥ 2 points in MG-ADL total score (proportion of patients with ≥ 3 improvement will be also presented)
Time frame: at month 6, 12, 24, 36
Change in the Revised 15-Component Myasthenia Gravis Quality of Life (MG-QOL15r) score
Time frame: at month 6, 12, 24, 36
Change from baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP)
Time frame: at month 6, 12, 24, 36
Change from baseline in Patient Global Impression of Change (PGI-C)
Time frame: at month 6, 12, 24, 36
Change from baseline in Neuro-Qol Short Form v1.0 - Fatigue
Time frame: at month 6, 12, 24, 36
Change from baseline in Patient Health Questionnaire - 9 (PHQ-9)
Time frame: at month 6, 12, 24, 36
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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