Myasthenia Gravis, GeneralizedMG-ARCADIANCT06909253
Ravulizumab Treatment Outcomes in Patients With Generalized Myasthenia Gravis
An observational study of Myasthenia Gravis, Generalized, run by AstraZeneca at 11 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis, Generalized
- What is being tested?
- Ravulizumab
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 11 sitesPoland
- Study dates
- 15 May 2025to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (aged ≥18 years) patients with gMG, naive to complement inhibitors, receiving ravulizumab treatment within the frames of NDP in Poland.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
11 sites in 1 country
Poland11 sites, 10 recruiting
- Recruiting
Research Site
Bydgoszcz
- Recruiting
Research Site
Gdansk
- Recruiting
Research Site
Katowice
- Recruiting
Research Site
Krakow
- Recruiting
Research Site
L DZ
- Recruiting
Research Site
Lublin
- Recruiting
Research Site
Poznan
- Recruiting
Research Site
Szczecin
- Withdrawn
Research Site
Szczecin
- Recruiting
Research Site
Warsaw
- Recruiting
Research Site
Wroclaw
About this study
Official title: 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.
Read the 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).
- Conditions
- Myasthenia Gravis, Generalized
- Being tested
- Ravulizumab
- Keywords
- Ravulizumab, Generalized Myasthenia Gravis, gMG, observational
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RavulizumabDrug
Also called Ultomiris
Ravulizumab, concentrate for solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Ravulizumab | Open-lable arm with gMG patients who received ravulizumab treatment in the frames of NDP in Poland. Receives: Drug: Ravulizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score
Measured: at 6 month
Secondary outcomes (9)
Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score
Measured: at month 12, 24, 36
Change from baseline in MG-ADL subcomponent scores
Subcomponent scores - bulbar, limbs, respiratory, and ocular
Measured: at month 6, 12, 24, 36
Change from baseline in Myasthenia Gravis (MG) composite scale
Measured: 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)
Measured: at month 6, 12, 24, 36
Change in the Revised 15-Component Myasthenia Gravis Quality of Life (MG-QOL15r) score
Measured: at month 6, 12, 24, 36
Change from baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP)
Measured: at month 6, 12, 24, 36
Change from baseline in Patient Global Impression of Change (PGI-C)
Measured: at month 6, 12, 24, 36
Change from baseline in Neuro-Qol Short Form v1.0 - Fatigue
Measured: at month 6, 12, 24, 36
Change from baseline in Patient Health Questionnaire - 9 (PHQ-9)
Measured: at month 6, 12, 24, 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start15 May 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia Gravis, GeneralizedStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909253
- Sponsor's protocol ID
- D9281R00004
- Acronym
- MG-ARCADIA
- Status last verified
- Sep 2026
- First submitted
- 27 Mar 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ravulizumab Treatment Outcomes in Patients With Generalized Myasthenia Gravis (gMG) Naive to Complement Inhibitors. Prospective, Multicenter, Non-interventional Study (MG-ARCADIA).
- ClinicalTrials.gov ID
- NCT06909253
- Acronym / sponsor ID
- MG-ARCADIA / D9281R00004
- Conditions
- Myasthenia Gravis, Generalized
- Keywords
- Ravulizumab, Generalized Myasthenia Gravis, gMG, observational
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 May 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Polish multicentre observational (non-interventional) study aiming to collect data on the management and clinical outcomes of patients with gMG that received ravulizumab.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ravulizumab | – | Drug: RavulizumabOpen-lable arm with gMG patients who received ravulizumab treatment in the frames of NDP in Poland. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (aged ≥18 years) patients with gMG, naive to complement inhibitors, receiving ravulizumab treatment within the frames of NDP in Poland.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RavulizumabAlso: UltomirisRavulizumab, concentrate for solution for infusion | Drug | Ravulizumab |
Primary outcome
Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score
Time frame: at 6 month
9 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, Generalized, run by AstraZeneca at 11 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score (time frame: at 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.