Trial Outcomes & Findings for A Cooperative Clinical Study of Abatacept in Multiple Sclerosis (NCT NCT01116427)
NCT ID: NCT01116427
Last Updated: 2016-09-15
Results Overview
The mean number of new inflammatory MRI lesions obtained on scans every 4 weeks from Week 8 to Week 24, adjusted for differences between subjects before treatment by subtracting the number of new inflammatory lesions observed from the week -1 MRI scan . An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Weeks 8-24
Results posted on
2016-09-15
Participant Flow
Participants with relapsing-remitting multiple sclerosis were recruited from 21 sites in the US and Canada between November 2010 and November 2013
Participant milestones
| Measure |
Abatacept First, Then Placebo
Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
Placebo First, Then Abatacept
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
|---|---|---|
|
Core Phase
STARTED
|
44
|
21
|
|
Core Phase
COMPLETED
|
39
|
20
|
|
Core Phase
NOT COMPLETED
|
5
|
1
|
|
Extension Phase
STARTED
|
38
|
20
|
|
Extension Phase
COMPLETED
|
29
|
18
|
|
Extension Phase
NOT COMPLETED
|
9
|
2
|
Reasons for withdrawal
| Measure |
Abatacept First, Then Placebo
Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
Placebo First, Then Abatacept
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
|---|---|---|
|
Core Phase
Adverse Event
|
0
|
1
|
|
Core Phase
Lost to Follow-up
|
1
|
0
|
|
Core Phase
Withdrawal by Subject
|
3
|
0
|
|
Core Phase
Worsening Multiple Sclerosis
|
1
|
0
|
|
Extension Phase
Adverse Event
|
1
|
1
|
|
Extension Phase
Lost to Follow-up
|
2
|
0
|
|
Extension Phase
Withdrawal by Subject
|
5
|
1
|
|
Extension Phase
Not using appropriate birth control
|
1
|
0
|
Baseline Characteristics
A Cooperative Clinical Study of Abatacept in Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Abatacept First, Then Placebo
n=44 Participants
Subjects received abatacept IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows: Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
Placebo First, Then Abatacept
n=21 Participants
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 9.7 • n=99 Participants
|
42.7 years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
41.2 years
STANDARD_DEVIATION 10.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
41 participants
n=99 Participants
|
19 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Baseline Expanded Disability Status Scale (EDSS) Score
|
2.0 units on a scale
STANDARD_DEVIATION 1.3 • n=99 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 1.2 • n=107 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 1.3 • n=206 Participants
|
|
Baseline Multiple Sclerosis Functional Composite (MSFC) Score
|
-0.01 Scores on a scale
STANDARD_DEVIATION 0.68 • n=99 Participants
|
0.03 Scores on a scale
STANDARD_DEVIATION 0.81 • n=107 Participants
|
0.00 Scores on a scale
STANDARD_DEVIATION 0.72 • n=206 Participants
|
|
Baseline Gd-enhanced Lesions
|
0.7 Lesions
STANDARD_DEVIATION 1.4 • n=99 Participants
|
3.8 Lesions
STANDARD_DEVIATION 10.7 • n=107 Participants
|
1.7 Lesions
STANDARD_DEVIATION 6.3 • n=206 Participants
|
|
Baseline T2 Lesion Volume
|
6.7 cm^3
STANDARD_DEVIATION 8.1 • n=99 Participants
|
9.6 cm^3
STANDARD_DEVIATION 9.0 • n=107 Participants
|
7.7 cm^3
STANDARD_DEVIATION 8.5 • n=206 Participants
|
PRIMARY outcome
Timeframe: Weeks 8-24Population: Intent-to-treat
The mean number of new inflammatory MRI lesions obtained on scans every 4 weeks from Week 8 to Week 24, adjusted for differences between subjects before treatment by subtracting the number of new inflammatory lesions observed from the week -1 MRI scan . An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.
Outcome measures
| Measure |
Abatacept First, Then Placebo
n=42 Participants
Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
Placebo First, Then Abatacept
n=20 Participants
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
|---|---|---|
|
Mean Number of New Inflammatory MRI Lesions Per Monthly Scans
|
0.4 New Lesions
Standard Deviation 0.9
|
1.7 New Lesions
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Weeks 4-24Population: Intent-to-treat
The absolute number of new inflammatory MRI lesions obtained on scans every 4 weeks from Week 8 to Week 24. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.
Outcome measures
| Measure |
Abatacept First, Then Placebo
n=42 Participants
Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
Placebo First, Then Abatacept
n=20 Participants
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
|---|---|---|
|
Absolute Number of New Inflammatory MRI Lesions on Monthly Scans
|
2.3 New Lesions
Standard Deviation 4.1
|
9.1 New Lesions
Standard Deviation 18.8
|
SECONDARY outcome
Timeframe: Week -1 to Week 24Population: Intent-to-treat population that did not terminate study prior to Week 24
Difference in total volume of all T2 lesions detected at Week 24 MRI scan compared to Week -1 MRI scan. A T2 lesion is defined as an abnormal, hyperintense white-matter area visible on T2 weighted images. A higher score indicates more severe multiple sclerosis.
Outcome measures
| Measure |
Abatacept First, Then Placebo
n=39 Participants
Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
Placebo First, Then Abatacept
n=19 Participants
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
|---|---|---|
|
Lesion Volume Accumulation on T2-weighted MRI Scans Over 24 Weeks
|
-0.05 cm^3
Standard Deviation 0.42
|
-0.18 cm^3
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: Week -1 to Week 24Population: Intent-to-treat population that did not terminate study prior to Week 24 and had MRI scans at both Week -1 and Week 24
Percent Brain Volume Change is a measure of brain atrophy. Brain volume was calculated from a MRI scan at Week -1 and a MRI scan at Week 24 then the percent change from Week -1 to Week 24 was calculated. A negative change score means volume decreased. A decrease in volume indicates progression of multiple sclerosis severity.
Outcome measures
| Measure |
Abatacept First, Then Placebo
n=39 Participants
Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
Placebo First, Then Abatacept
n=18 Participants
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
|---|---|---|
|
Percent Brain Volume Change
|
-0.09 percent change
Standard Deviation 0.54
|
-0.25 percent change
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Week 8 to Week 24Population: Intent-to-treat
The mean number of new inflammatory MRI lesions obtained on scans every 8 weeks from Week 8 to Week 24. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.
Outcome measures
| Measure |
Abatacept First, Then Placebo
n=42 Participants
Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
Placebo First, Then Abatacept
n=20 Participants
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
|---|---|---|
|
Mean Number of New Inflammatory Lesions in 8-week Intervals
|
0.5 New Lesions
Standard Deviation 1.2
|
2.2 New Lesions
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Week -1 to Week 24Population: Intent-to-treat
The Expanded Disability Status Scale (EDSS) is an assessment for severity of multiple sclerosis. The EDSS an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to multiple sclerosis) in half-point increments. Baseline EDSS score was the lowest score observed at either visit -2 (Wk -5) or visit -1 (Wk -1). EDSS progression is defined as an increase of at least 1 point on the EDSS compared to baseline if the baseline was greater than 1.0, or 1.5 points on EDSS if baseline was less than or equal to 1.0, which persisted for a minimum of 12 weeks or was found on three consecutive EDSS assessments starting at Visit 3 (Wk 8).
Outcome measures
| Measure |
Abatacept First, Then Placebo
n=42 Participants
Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
Placebo First, Then Abatacept
n=20 Participants
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
|---|---|---|
|
Number of Participants Progressing on the EDSS Scale by at Least 1 Point
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week -1 to Week 24Population: Intent-to-treat
The rate of multiple sclerosis relapse by year. Annualized relapse rate is calculated by dividing the total number of relapse events in the core phase in each treatment group by the total number of days participants participated in the study during the core phase. This number is then multiplied by 365.25 to get an annualized rate.
Outcome measures
| Measure |
Abatacept First, Then Placebo
n=42 Participants
Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
Placebo First, Then Abatacept
n=20 Participants
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
|---|---|---|
|
Annualized Relapse Rate
|
0.13 Relapse Rate by Year
|
0.09 Relapse Rate by Year
|
SECONDARY outcome
Timeframe: Week -1 to Week 24Population: Intent-to-treat
The Multiple Sclerosis Functional Composite (MSFC) is a three-part, standardized, quantitative assessment instrument to measure severity of multiple sclerosis. The MSFC combines three component measures to create a composite measure. The three component measures of the MSFC include the 1) Time 25-foot Walk (a measure of lower extremity function), 2) 9-hole Peg Test (a measure of upper extremity function), and 3) Paced Auditory Serial Addition Test (a measure of cognitive function). Mean change in MSFC scores from baseline to Week 24 were assessed. Scores from all three components are combined then are converted into a Z-score for analyses, with a range from -1 to 1. A positive score indicates improvement in the severity of multiple sclerosis symptoms while negative scores indicate decline in multiple sclerosis symptoms.
Outcome measures
| Measure |
Abatacept First, Then Placebo
n=42 Participants
Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
Placebo First, Then Abatacept
n=20 Participants
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
|---|---|---|
|
Mean Change in the MSFC Over 24 Weeks of Treatment
|
0.10 Scores on a scale
Standard Deviation 0.30
|
-0.04 Scores on a scale
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: Weeks 36 and 52Population: Intent-to-treat in Extension Phase
The mean number of new inflammatory MRI lesions obtained on scans at Weeks 36 and 52, adjusted for differences between subjects before treatment by subtracting the number of new inflammatory lesions observed from the week 24 MRI scan. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.
Outcome measures
| Measure |
Abatacept First, Then Placebo
n=34 Participants
Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
Placebo First, Then Abatacept
n=19 Participants
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
|---|---|---|
|
Mean Number of New Inflammatory MRI Lesions Per Scan During the Extension Phase
|
1.3 New Lesions
Standard Deviation 2.7
|
0.6 New Lesions
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Week 24 to Week 52Population: Intent-to-treat in Extension Phase who had an MRI at Week 52
Difference in total volume of all T2 lesions detected at Week 52 MRI scan compared to Week 24 MRI scan. A T2 lesion is defined as an abnormal, hyperintense white-matter area visible on T2 weighted images. A higher score indicates more severe multiple sclerosis.
Outcome measures
| Measure |
Abatacept First, Then Placebo
n=26 Participants
Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
Placebo First, Then Abatacept
n=16 Participants
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
|---|---|---|
|
Lesion Volume Accumulation on T2-Weighted MRI Scans Between 24 Weeks and 52 Weeks
|
0.47 cm^3
Standard Deviation 0.99
|
0.07 cm^3
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Week 24 to Week 52Population: Intent-to-treat in Extension Phase who had an MRI at Week 52 with data to contribute to brain volume measurements
Percent Brain Volume Change is a measure of brain atrophy. Brain volume was calculated from a MRI scan at Week 24 and a MRI scan at Week 25 then the percent change from Week 24 to Week 52 was calculated. A negative change score means volume decreased. A decrease in volume indicates progression of multiple sclerosis severity.
Outcome measures
| Measure |
Abatacept First, Then Placebo
n=24 Participants
Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
Placebo First, Then Abatacept
n=16 Participants
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
|---|---|---|
|
Percent Brain Volume Change Between 24 Weeks and 52 Weeks
|
-0.28 Percent change
Standard Deviation 0.42
|
-0.31 Percent change
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Week 24 to Week 64Population: Intent-to-treat in Extension Phase
The Expanded Disability Status Scale (EDSS) is an assessment for severity of multiple sclerosis. The EDSS an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to multiple sclerosis) in half-point increments. Extension baseline EDSS score was the most recent non-missing value on or before Week 28. Only participants who scored between a 0 and a 5 at baseline were analyzed for this outcome measure. EDSS progression is defined as an increase of at least 1 point on the EDSS compared to baseline if the baseline was greater than 1.0, or 1.5 points on EDSS if baseline was less than or equal to 1.0, which persisted for a minimum of 12 weeks or was found on three consecutive EDSS assessments starting at Visit 3 (Wk 8).
Outcome measures
| Measure |
Abatacept First, Then Placebo
n=34 Participants
Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
Placebo First, Then Abatacept
n=19 Participants
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
|---|---|---|
|
Number of Participants Progressing on the EDSS Scale by at Least 1 Point
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Week 24 to Week 64Population: Intent-to-treat in Extension Phase
The rate of multiple sclerosis relapse by year. Annualized relapse rate is calculated by dividing the total number of relapse events in the extension and follow-up phases in each treatment group by the total number of days participants participated in the study during the extension and follow-up phases. This number is then multiplied by 365.25 to get an annualized rate.
Outcome measures
| Measure |
Abatacept First, Then Placebo
n=34 Participants
Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
Placebo First, Then Abatacept
n=19 Participants
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
|---|---|---|
|
Annualized Relapse in Extension Phase
|
0.38 Relapse Rate by Year
|
0.16 Relapse Rate by Year
|
SECONDARY outcome
Timeframe: Week 24 to Week 52Population: Intent-to-treat in Extension Phase who Completed the MSFC at Week 52
The Multiple Sclerosis Functional Composite (MSFC) is a three-part, standardized, quantitative assessment instrument to measure severity of multiple sclerosis. The MSFC combines three component measures to create a composite measure. The three component measures of the MSFC include the 1) Time 25-foot Walk (a measure of lower extremity function), 2) 9-hole Peg Test (a measure of upper extremity function), and 3) Paced Auditory Serial Addition Test (a measure of cognitive function). Mean change in MSFC scores from Week 24 to Week 52 were assessed. Scores from all three components are combined then are converted into a Z-score for analyses, with a range from -1 to 1. A positive score indicates improvement in the severity of multiple sclerosis symptoms while negative scores indicate decline in multiple sclerosis symptoms.
Outcome measures
| Measure |
Abatacept First, Then Placebo
n=27 Participants
Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
Placebo First, Then Abatacept
n=18 Participants
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
|
|---|---|---|
|
Mean Change in the MSFC in Extension Phase
|
0.06 Scores on a scale
Standard Deviation 0.21
|
-0.01 Scores on a scale
Standard Deviation 0.46
|
Adverse Events
Core Phase: Abatacept -> Placebo
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Core Phase: Placebo -> Abatacept
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Extension Phase: Abatacept -> Placebo
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Extension Phase: Placebo -> Abatacept
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Follow-up Phase: Abatacept -> Placebo
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Follow-up Phase: Placebo -> Abatacept
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Core Phase: Abatacept -> Placebo
n=44 participants at risk
Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. Dosing of abatacept was as follows:
Participants weighing-
* less than 60 kg received 500 mg;
* 60-100 kg received 750 mg; and
* greater than 100 kg received 1 g.
|
Core Phase: Placebo -> Abatacept
n=21 participants at risk
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24.
|
Extension Phase: Abatacept -> Placebo
n=37 participants at risk
After week 24, participants in Abatacept -\> Placebo group eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52.
|
Extension Phase: Placebo -> Abatacept
n=19 participants at risk
After week 24, participants in the Placebo -\> Abatacept group eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Dosing of abatacept was as follows:
Participants weighing-
* less than 60 kg received 500 mg;
* 60-100 kg received 750 mg; and
* greater than 100 kg received 1 g.
|
Follow-up Phase: Abatacept -> Placebo
n=29 participants at risk
Following Week 52, participants in the Abatacept -\> Placebo group completed an additional 12 weeks of observation until week 64.
|
Follow-up Phase: Placebo -> Abatacept
n=18 participants at risk
Following Week 52, participants in the Placebo -\> Abatacept group completed an additional 12 weeks of observation until week 64.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Herpes zoster
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/19 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
3.4%
1/29 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/19 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
3.4%
1/29 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/19 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.6%
1/18 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/19 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
3.4%
1/29 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
1/44 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/19 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Nervous system disorders
Hypoaesthesia
|
2.3%
1/44 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/19 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
2.3%
1/44 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.4%
2/37 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/19 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
6.9%
2/29 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
Other adverse events
| Measure |
Core Phase: Abatacept -> Placebo
n=44 participants at risk
Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. Dosing of abatacept was as follows:
Participants weighing-
* less than 60 kg received 500 mg;
* 60-100 kg received 750 mg; and
* greater than 100 kg received 1 g.
|
Core Phase: Placebo -> Abatacept
n=21 participants at risk
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24.
|
Extension Phase: Abatacept -> Placebo
n=37 participants at risk
After week 24, participants in Abatacept -\> Placebo group eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52.
|
Extension Phase: Placebo -> Abatacept
n=19 participants at risk
After week 24, participants in the Placebo -\> Abatacept group eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Dosing of abatacept was as follows:
Participants weighing-
* less than 60 kg received 500 mg;
* 60-100 kg received 750 mg; and
* greater than 100 kg received 1 g.
|
Follow-up Phase: Abatacept -> Placebo
n=29 participants at risk
Following Week 52, participants in the Abatacept -\> Placebo group completed an additional 12 weeks of observation until week 64.
|
Follow-up Phase: Placebo -> Abatacept
n=18 participants at risk
Following Week 52, participants in the Placebo -\> Abatacept group completed an additional 12 weeks of observation until week 64.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Vision blurred
|
2.3%
1/44 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
2.7%
1/37 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
4.8%
1/21 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/44 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
2.7%
1/37 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
General disorders
Fatigue
|
11.4%
5/44 • Number of events 5 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
19.0%
4/21 • Number of events 4 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
2.7%
1/37 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/19 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
General disorders
Influenza like illness
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
General disorders
Oedema peripheral
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Infections and infestations
Bronchitis
|
2.3%
1/44 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.4%
2/37 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/19 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
2.7%
1/37 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.4%
5/44 • Number of events 8 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
9.5%
2/21 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/19 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
4/44 • Number of events 5 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
14.3%
3/21 • Number of events 5 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
10.5%
2/19 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Investigations
Mean cell haemoglobin concentration decreased
|
2.3%
1/44 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.4%
2/37 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
10.5%
2/19 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.6%
1/18 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Investigations
Neutrophil count decreased
|
2.3%
1/44 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.4%
2/37 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/19 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.3%
1/44 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.4%
2/37 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/19 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
2/44 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.4%
2/37 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Nervous system disorders
Balance disorder
|
2.3%
1/44 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Nervous system disorders
Headache
|
11.4%
5/44 • Number of events 11 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
19.0%
4/21 • Number of events 5 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
10.8%
4/37 • Number of events 4 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Nervous system disorders
Hypoaesthesia
|
6.8%
3/44 • Number of events 4 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
4.8%
1/21 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.4%
2/37 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
10.5%
2/19 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
3.4%
1/29 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
4.5%
2/44 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
9.5%
2/21 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
8.1%
3/37 • Number of events 3 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.6%
1/18 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Nervous system disorders
Paraesthesia
|
4.5%
2/44 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
4.8%
1/21 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
2.7%
1/37 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/19 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.6%
1/18 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
4.8%
1/21 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.4%
2/37 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/19 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/19 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.6%
1/18 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Psychiatric disorders
Depression
|
2.3%
1/44 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
9.5%
2/21 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.4%
2/37 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/19 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
8.1%
3/37 • Number of events 3 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
4.8%
1/21 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.3%
1/44 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
9.5%
2/21 • Number of events 2 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
2.7%
1/37 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/19 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/44 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/21 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
|
Vascular disorders
Hypertension
|
2.3%
1/44 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
4.8%
1/21 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/37 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
5.3%
1/19 • Number of events 1 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/29 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
0.00%
0/18 • From enrollment until end of study (up to 64 weeks).
Participants At Risk:1.) for the Core Phase=all who received at least one dose in the Core Phase 2.) for the Extension Phase=all who received at least one dose in the Extension Phase; and 3.) for the Follow-up Phase =all participants who completed the Extension Phase.
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place