Ravulizumab Treatment Outcomes in Patients With Generalized Myasthenia Gravis (MG-ARCADIA)

May 14, 2026 updated by: AstraZeneca

Ravulizumab Treatment Outcomes in Patients With Generalized Myasthenia Gravis (gMG) Naive to Complement Inhibitors. Prospective, Multicenter, Non-interventional Study (MG-ARCADIA).

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Bydgoszcz, Poland
        • Recruiting
        • Research Site
      • Gdansk, Poland
        • Recruiting
        • Research Site
      • Katowice, Poland
        • Not yet recruiting
        • Research Site
      • Katowice, Poland
        • Recruiting
        • Research Site
      • Krakow, Poland
        • Recruiting
        • Research Site
      • Lodz, Poland
        • Recruiting
        • Research Site
      • Lublin, Poland
        • Recruiting
        • Research Site
      • Poznan, Poland
        • Not yet recruiting
        • Research Site
      • Poznan, Poland
        • Withdrawn
        • Research Site
      • Szczecin, Poland
        • Not yet recruiting
        • Research Site
      • Szczecin, Poland
        • Recruiting
        • Research Site
      • Warsaw, Poland
        • Recruiting
        • Research Site
      • Wroclaw, Poland
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult (aged ≥18 years) patients with gMG, naive to complement inhibitors, receiving ravulizumab treatment within the frames of NDP in Poland.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ravulizumab
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
Other Names:
  • Ultomiris

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score
Time Frame: at 6 month
at 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score
Time Frame: at month 12, 24, 36
at month 12, 24, 36
Change from baseline in MG-ADL subcomponent scores
Time Frame: at month 6, 12, 24, 36
Subcomponent scores - bulbar, limbs, respiratory, and ocular
at month 6, 12, 24, 36
Change from baseline in Myasthenia Gravis (MG) composite scale
Time Frame: at month 6, 12, 24, 36
at month 6, 12, 24, 36
Proportion of patients who achieved response
Time Frame: at month 6, 12, 24, 36
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
Time Frame: at month 6, 12, 24, 36
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
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
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
at month 6, 12, 24, 36
Change from baseline in Patient Health Questionnaire - 9 (PHQ-9)
Time Frame: at month 6, 12, 24, 36
at month 6, 12, 24, 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

April 3, 2025

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9281R00004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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