Ravulizumab Treatment Outcomes in Patients With Generalized Myasthenia Gravis
MG-ARCADIA
1 other identifier
observational
50
1 country
14
Brief Summary
The Polish multicentre observational (non-interventional) study aiming to collect data on the management and clinical outcomes of patients with gMG that received ravulizumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2025
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2025
CompletedFirst Posted
Study publicly available on registry
April 3, 2025
CompletedStudy Start
First participant enrolled
May 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
April 17, 2026
April 1, 2026
4.6 years
March 27, 2025
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score
at 6 month
Secondary Outcomes (9)
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
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
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
- +4 more secondary outcomes
Study Arms (1)
Ravulizumab
Open-lable arm with gMG patients who received ravulizumab treatment in the frames of NDP in Poland.
Interventions
Ravulizumab, concentrate for solution for infusion
Eligibility Criteria
Adult (aged ≥18 years) patients with gMG, naive to complement inhibitors, receiving ravulizumab treatment within the frames of NDP in Poland.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (14)
Research Site
Bydgoszcz, Poland
Research Site
Gdansk, Poland
Research Site
Katowice, Poland
Research Site
Katowice, Poland
Research Site
Krakow, Poland
Research Site
Lodz, Poland
Research Site
Lublin, Poland
Research Site
Poznan, Poland
Research Site
Poznan, Poland
Research Site
Szczecin, Poland
Research Site
Szczecin, Poland
Research Site
Warsaw, Poland
Research Site
Warsaw, Poland
Research Site
Wroclaw, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2025
First Posted
April 3, 2025
Study Start
May 15, 2025
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 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.
- Access Criteria
- 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
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.