Real world treatment satisfaction of MG patients with complement-inhibitors in Germany - a multicenter non-interventional trial

Real world treatment satisfaction of MG patients with complement-inhibitors in Germany - a multicenter non-interventional trial - RWE RavEcu

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030410

Enrollment

Registered

2022-11-09

Start date

2022-11-24

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G70.0

Interventions

Group 1: Patients with generalized myasthenia gravis who are newly treated with a complement-inihibtor (either eculizumab or ravulizumab) within routine clinical practice, will be monitored for 6 mont

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - patients with a AchR-Ab+ generalized myasthenia gravis who are planned to start treatment with either eculizumab or ravulizumab according to approval criteria and within clinical routine - patients can be either complement-inhibitor-treatment naïve or switch from one substance to the other - written informed consent - minimum age 18 years

Exclusion criteria

Exclusion criteria: - participation in another interventional trial (participation in a non-interventional trial is allowed)

Design outcomes

Primary

Measure	Time frame
absolute change in TSQM-9 score subscale "global satisfaction" at visit 10 compared to baseline	—

Secondary

Measure	Time frame
- absolute change in TSQM-9 score subscale "global satisfaction" during visits 2-8 compared to baseline - absolute change in TSQM-9 score subscales for effectiveness and convenience comparing all visits to baseline - change in MG-ADL (Myasthenia gravis Activities of Daily Living) comparing visit 9 and baseline - change in PASS (Patient Acceptable Symptom State) comparing visit 9 and baseline - change in SSQ (single simple question) comparing visit 9 and baseline - change in MG-QoLr (Myasthenia gravis Quality of life revised) comparing visit 9 and baseline - change in QMG (Quantitative Myasthenia gravis Score) comparing visit 9 and baseline - change in MGFA-Score (Myasthenia Gravis Foundation of America) comparing visit 9 and baseline - change in myasthenia specific comedication compared to baseline - adherence for Complement-Inhibitor-doses during study period - medication side effects will be monitored at each study visit	—

Measure

Time frame

- absolute change in TSQM-9 score subscale "global satisfaction" during visits 2-8 compared to baseline - absolute change in TSQM-9 score subscales for effectiveness and convenience comparing all visits to baseline - change in MG-ADL (Myasthenia gravis Activities of Daily Living) comparing visit 9 and baseline - change in PASS (Patient Acceptable Symptom State) comparing visit 9 and baseline - change in SSQ (single simple question) comparing visit 9 and baseline - change in MG-QoLr (Myasthenia gravis Quality of life revised) comparing visit 9 and baseline - change in QMG (Quantitative Myasthenia gravis Score) comparing visit 9 and baseline - change in MGFA-Score (Myasthenia Gravis Foundation of America) comparing visit 9 and baseline - change in myasthenia specific comedication compared to baseline - adherence for Complement-Inhibitor-doses during study period - medication side effects will be monitored at each study visit

—

Countries

Germany

Contacts

Public Contactintegriertes Myastheniezentrum der Charité

Klinik für NeurologieNeuroCure Clinical Research Center (NCRC)Charité Universitätsmedizin Berlin Campus Mitte

myasthenie@charite.de+4930450639778

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026