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Ravulizumab Treatment Outcomes in Patients With Generalized Myasthenia Gravis

ConditionMyasthenia Gravis, Generalized
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ravulizumab

    Drug

    Ravulizumab, concentrate for solution for infusion

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Ravulizumab1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score

Time frame
at 6 month

Secondary outcomes

1

Change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score

Time frame
at month 12, 24, 36
2

Change from baseline in MG-ADL subcomponent scores

Subcomponent scores - bulbar, limbs, respiratory, and ocular

Time frame
at month 6, 12, 24, 36
3

Change from baseline in Myasthenia Gravis (MG) composite scale

Time frame
at month 6, 12, 24, 36
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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