Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of IGIV-C in Patients With Myasthenia Gravis Exacerbations (NCT NCT02413580)
NCT ID: NCT02413580
Last Updated: 2020-04-24
Results Overview
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.
COMPLETED
PHASE3
49 participants
From Baseline (Day 0) to Day 14
2020-04-24
Participant Flow
Participant milestones
| Measure |
IGIV-C Treatment
An IV dose of 2 g/kg of IGIV-C was administered in subjects with myasthenia gravis exacerbations.
IGIV-C: an IV dose of 2 g/kg of IGIV-C was administered as 2 doses of 1 g/kg on two consecutive days
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Efficacy and Safety of IGIV-C in Patients With Myasthenia Gravis Exacerbations
Baseline characteristics by cohort
| Measure |
IGIV-C Treatment
n=49 Participants
An IV dose of 2 g/kg of IGIV-C was administered in subjects with myasthenia gravis exacerbations.
IGIV-C: an IV dose of 2 g/kg of IGIV-C was administered as 2 doses of 1 g/kg on two consecutive days
|
|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
47.3 year
STANDARD_DEVIATION 15.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Latvia
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
4 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
2 participants
n=5 Participants
|
|
Region of Enrollment
France
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 0) to Day 14Population: The primary efficacy analysis of change in the score of MG symptoms as measured by the change in QMG score from Baseline (Day 0) to Day 14 in the Evaluable population which consisted of all subjects who received the entire dose of Investigational Product (2 g/kg over 2 consecutive days) and had valid baseline and Day 14 QMG Score measurements.
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.
Outcome measures
| Measure |
IGIV-C Treatment
n=43 Participants
An IV dose of 2 g/kg of IGIV-C was administered in subjects with myasthenia gravis exacerbations.
IGIV-C: an IV dose of 2 g/kg of IGIV-C was administered as 2 doses of 1 g/kg on two consecutive days
|
|---|---|
|
Change in Quantitative Myasthenia Gravis (QMG) Scale Score
|
-6.4 score on a scale
Standard Deviation 5.15
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 14Population: The percentage of subjects with clinical improvement at Day 14 as assessed by the QMG scale in the Evaluable population is presented.
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.
Outcome measures
| Measure |
IGIV-C Treatment
n=43 Participants
An IV dose of 2 g/kg of IGIV-C was administered in subjects with myasthenia gravis exacerbations.
IGIV-C: an IV dose of 2 g/kg of IGIV-C was administered as 2 doses of 1 g/kg on two consecutive days
|
|---|---|
|
Percentage of Subjects With Clinical Improvement Assessed by QMG
|
33 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 14Population: The percentage of subjects with clinical improvement at Day 14 as assessed by the MG-ADL in the Evaluable population is presented.
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.
Outcome measures
| Measure |
IGIV-C Treatment
n=43 Participants
An IV dose of 2 g/kg of IGIV-C was administered in subjects with myasthenia gravis exacerbations.
IGIV-C: an IV dose of 2 g/kg of IGIV-C was administered as 2 doses of 1 g/kg on two consecutive days
|
|---|---|
|
Percentage of Subjects With Clinical Improvement Assessed by MG-Activities of Daily Living (MG-ADL) Scale
|
38 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Day 14Population: The percentage of subjects with clinical improvement at Day 14 as assessed by the MG Composite scale in the Evaluable population is presented.
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.
Outcome measures
| Measure |
IGIV-C Treatment
n=43 Participants
An IV dose of 2 g/kg of IGIV-C was administered in subjects with myasthenia gravis exacerbations.
IGIV-C: an IV dose of 2 g/kg of IGIV-C was administered as 2 doses of 1 g/kg on two consecutive days
|
|---|---|
|
Percentage of Subjects With Clinical Improvement Assessed by the MG Composite
|
37 Participants
|
Adverse Events
IGIV-C Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IGIV-C Treatment
n=49 participants at risk
An IV dose of 2 g/kg of IGIV-C was administered in subjects with myasthenia gravis exacerbations.
IGIV-C: an IV dose of 2 g/kg of IGIV-C was administered as 2 doses of 1 g/kg on two consecutive days
|
|---|---|
|
Nervous system disorders
Headache
|
38.8%
19/49 • Number of events 21 • Subjects with MG exacerbations not attributable to an infection or change in medication were planned to receive 2 g/kg of IGIV-C on Day 0 (Baseline) and on Day 1 (dosed as 1 g/kg per day), followed by 28 days of post-infusion assessments. During this 30-day period, the adverse event data were collected.
|
|
General disorders
Influenza like illness
|
6.1%
3/49 • Number of events 3 • Subjects with MG exacerbations not attributable to an infection or change in medication were planned to receive 2 g/kg of IGIV-C on Day 0 (Baseline) and on Day 1 (dosed as 1 g/kg per day), followed by 28 days of post-infusion assessments. During this 30-day period, the adverse event data were collected.
|
|
General disorders
Pyrexia
|
16.3%
8/49 • Number of events 9 • Subjects with MG exacerbations not attributable to an infection or change in medication were planned to receive 2 g/kg of IGIV-C on Day 0 (Baseline) and on Day 1 (dosed as 1 g/kg per day), followed by 28 days of post-infusion assessments. During this 30-day period, the adverse event data were collected.
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
3/49 • Number of events 3 • Subjects with MG exacerbations not attributable to an infection or change in medication were planned to receive 2 g/kg of IGIV-C on Day 0 (Baseline) and on Day 1 (dosed as 1 g/kg per day), followed by 28 days of post-infusion assessments. During this 30-day period, the adverse event data were collected.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.2%
4/49 • Number of events 4 • Subjects with MG exacerbations not attributable to an infection or change in medication were planned to receive 2 g/kg of IGIV-C on Day 0 (Baseline) and on Day 1 (dosed as 1 g/kg per day), followed by 28 days of post-infusion assessments. During this 30-day period, the adverse event data were collected.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.1%
3/49 • Number of events 4 • Subjects with MG exacerbations not attributable to an infection or change in medication were planned to receive 2 g/kg of IGIV-C on Day 0 (Baseline) and on Day 1 (dosed as 1 g/kg per day), followed by 28 days of post-infusion assessments. During this 30-day period, the adverse event data were collected.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site may publish results from the Study, after providing Sponsor thirty days' notice prior to submitting a manuscript or other materials related to the Study to any outside party. At Sponsors' request, Site will remove any Confidential Information (other than Study results), and Site will upon Sponsors' request, delay publication or presentation for a period of up to one hundred twenty days to allow Sponsor to protect its interests in any Sponsor Inventions.
- Publication restrictions are in place
Restriction type: OTHER