This was a multicenter, prospective, open-label, non-controlled study to assess the efficacy and safety of an IV dose of 2 g/kg of IGIV-C in subjects with MG exacerbations.
The study consisted of a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments. The total duration of study participation for each subject was up to 28 ± 2 days. Approximately 50 subjects, ages 18 or greater, were planned to be enrolled in the study and receive a single, total dose of 2 g/kg of IGIV-C over 2 consecutive days (dose of 1 g/kg per day) across multiple centers in Argentina, Canada, Europe, and South Africa.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
An IV dose of 2 g/kg of IGIV-C was administered over 2 consecutive days at a dose of 1 g/kg per day.
Change in Quantitative Myasthenia Gravis (QMG) Scale Score
Mean Change in Quantitative Myasthenia Gravis (QMG) Scale Score from Baseline (Day 0) to Day 14. The minimum and maximum scores of the QMG Scale are 0 and 39, respectively, and a higher score means a worse outcome.
Time frame: From Baseline (Day 0) to Day 14
Percentage of Subjects With Clinical Improvement Assessed by QMG
The percentage of subjects with clinical improvement at Day 14 as assessed by the Quantitative Myasthenia Gravis (QMG) scale in the Evaluable population is presented, in which clinical improvement is defined as at least 3-point decrease in QMG score from Baseline (Day 0) to Day 14. The minimum and maximum scores of the QMG scale are 0 and 39, respectively, and a higher score means a worse outcome.
Time frame: Baseline (Day 0) to Day 14
Percentage of Subjects With Clinical Improvement Assessed by MG-Activities of Daily Living (MG-ADL) Scale
The percentage of subjects with clinical improvement at Day 14 as assessed by the MG-ADL Scale in the Evaluable population is presented, in which clinical improvement is defined as at least 2-point decrease in the MG-ADL score. The minimum and maximum scores of the MG-DAL scale are 0 and 24, respectively, and a higher score means a worse outcome.
Time frame: Baseline (Day 0) to Day 14
Percentage of Subjects With Clinical Improvement Assessed by the MG Composite
The percentage of subjects with clinical improvement at Day 14 as assessed by the MG Composite scale in the Evaluable population is presented in which clinical improvement is defined as at least 3-point decrease in the MG Composite score. The minimum and maximum scores of the MG Composite scale are 0 and 50, respectively, with a higher score meaning a worse outcome.
Time frame: Baseline (Day 0) to Day 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital Italiano
Buenos Aires, Argentina
Hospital General de Agudos Dr. J. M.
Buenos Aires, Argentina
Hospital Cordoba
Córdoba, Argentina
AZ St Lucas Gent
Ghent, East Flanders, Belgium
UZ Leuven
Leuven, Belgium
University of Alberta Hospital
Edmonton, Alberta, Canada
London Health Sciences Centre
London, Ontario, Canada
University Health Network (UHN) - Toronto General Hospital
Toronto, Ontario, Canada
Fakultni nemocnice Brno, Neurologicka klinika
Brno, Czechia
Fakultni nemocnice Ostrava, Neurologická klinika
Ostrava, Czechia
...and 21 more locations