Generalized Myasthenia Gravis (gMG)
Conditions
Brief summary
Mean of the average MG-ADL total score change from baseline during the visit of week (W)1 through W21 by regimen arm
Detailed description
Incidence and severity of AEs, incidence of serious adverse events (SAEs), incidence of AESIs, and changes in laboratory test results, vital sign measurements, and electrocardiogram results, Change from baseline in the MG-ADL total score over time, Normalized area under the effect curve (AUEC) of MG-ADL total score improvement from baseline during the following intervals: day 1 through W7; W7 through W14; W14 through W21; W7 through W21, Characterization of MG-ADL total score change from baseline during the following 5 intervals using mean and standard deviation: W1 through W7; W8 through W14; W15 through W21; W8 through W21; W1 through W21, Number and percentage of participants who have a ≥ 2, 3, 4, or 5 points improvement in MG-ADL total score from baseline during the following 5 intervals: W1 through W7; W8 through W14; W15 through W21; W8 through W21; W1 through W21, Percentage of time participants have a reduction in MG-ADL total score of at least 2 points from baseline during W4 through W21, Number and percentage of participants who achieve minimal symptom expression (MSE), defined as a MG-ADL total score of 0 or 1, in the following 5 intervals: W1 through W7; W8 through W14; W15 through W21; W8 through W21; W1 through W21
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean of the average MG-ADL total score change from baseline during the visit of week (W)1 through W21 by regimen arm | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of AEs, incidence of serious adverse events (SAEs), incidence of AESIs, and changes in laboratory test results, vital sign measurements, and electrocardiogram results, Change from baseline in the MG-ADL total score over time, Normalized area under the effect curve (AUEC) of MG-ADL total score improvement from baseline during the following intervals: day 1 through W7; W7 through W14; W14 through W21; W7 through W21, Characterization of MG-ADL total score change from baseline during the following 5 intervals using mean and standard deviation: W1 through W7; W8 through W14; W15 through W21; W8 through W21; W1 through W21, Number and percentage of participants who have a ≥ 2, 3, 4, or 5 points improvement in MG-ADL total score from baseline during the following 5 intervals: W1 through W7; W8 through W14; W15 through W21; W8 through W21; W1 through W21, Percentage of time participants have a reduction in MG-ADL total score of at least 2 points from baseline during W4 | — |
Countries
Austria, Belgium, France, Germany, Italy, Poland, Spain