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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ravulizumab | Open-lable arm with gMG patients who received ravulizumab treatment in the frames of NDP in Poland. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ravulizumab | Drug | Ravulizumab, concentrate for solution for infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score | at 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score | at month 12, 24, 36 | |
| Change from baseline in MG-ADL subcomponent scores | Subcomponent scores - bulbar, limbs, respiratory, and ocular |
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Inclusion Criteria:
Exclusion Criteria:
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Adult (aged ≥18 years) patients with gMG, naive to complement inhibitors, receiving ravulizumab treatment within the frames of NDP in Poland.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Bydgoszcz | Poland | |||
| Research Site |
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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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
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| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000629409 | ravulizumab |
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| at month 6, 12, 24, 36 |
| Change from baseline in Myasthenia Gravis (MG) composite scale | 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) | at month 6, 12, 24, 36 |
| Change in the Revised 15-Component Myasthenia Gravis Quality of Life (MG-QOL15r) score | at month 6, 12, 24, 36 |
| Change from baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) | at month 6, 12, 24, 36 |
| Change from baseline in Patient Global Impression of Change (PGI-C) | at month 6, 12, 24, 36 |
| Change from baseline in Neuro-Qol Short Form v1.0 - Fatigue | at month 6, 12, 24, 36 |
| Change from baseline in Patient Health Questionnaire - 9 (PHQ-9) | at month 6, 12, 24, 36 |
| Recruiting |
| Gdansk |
| Poland |
| Research Site | Recruiting | Katowice | Poland |
| Research Site | Recruiting | Krakow | Poland |
| Research Site | Recruiting | Lodz | Poland |
| Research Site | Recruiting | Lublin | Poland |
| Research Site | Withdrawn | Poznan | Poland |
| Research Site | Not yet recruiting | Poznan | Poland |
| Research Site | Recruiting | Szczecin | Poland |
| Research Site | Not yet recruiting | Szczecin | Poland |
| Research Site | Recruiting | Warsaw | Poland |
| Research Site | Recruiting | Wroclaw | Poland |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |