generalized Myasthenia Gravis
Conditions
Interventions
None listed
Sponsors
Ng Pauline
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >=18 years at the time of obtaining eConsent and residing in Japan. 2. Patients who are diagnosed with generalized Myasthenia Gravis by neurologists and have certification of designated intractable disease for Myasthenia Gravis in Japan. 3. Patients and/or their legally-acceptable representative where applicable must sign a participation agreement/eConsent allowing source data verification in accordance with local requirements. 4. Patients who are receiving the Fast-acting treatment or cyclical Neonatal Fc receptor inhibitor (intravenous or subcutaneous efgartigimod and rozanolixizumab) according to the package insert to maintain generalized Myasthenia Gravis symptoms in outpatient care in Japan. The Fast-acting treatment includes Intravenous Immunoglobulin G, Plasma Exchange, Plasmapheresis, Immune-Absorption Plasmapheresis, and pulse dose of Intravenous Methyl Prednisolone therapy or these combinations. 5. Patients who have a MG-ADL score of 4 or greater at the time of study initiation 6. Patients who are able and willing to answer the ePRO App. 7. Patients who have a personal smartphone which can download the required Apps.
Exclusion criteria
Exclusion criteria: 1. Patients working at night-time or on night-time shifts. 2. Patients with the Myasthenia Gravis Foundation of America (MGFA) classification status I or V. 3. Patients currently enrolled or plan to be enrolled (during this study period) in another Janssen-sponsored investigational study or an observational study. 4. Patients who are maintaining with nipocalimab or complement inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in MG-ADL score from previous observation | — |
Secondary
| Measure | Time frame |
|---|---|
| Observed score and change from previous observation in the following measures; - PASS - FSS score - MG-QOL-15r score - WPAI-GH score - HADS score To examine relationships between changes in MG-ADL and following outcomes in the same time frame; - Change in PASS - Change in QOL (PASS, FSS and MG-QOL-15r) - Change in work productivity (PASS, FSS and WPAI-GH) | — |
Contacts
Public ContactTeita Asano
Janssen Pharmaceutical K.K.
Outcome results
None listed