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A Cooperative Clinical Study of Abatacept in Multiple Sclerosis (ACCLAIM)

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ClinicalTrials.gov Identifier: NCT01116427
Recruitment Status : Completed
First Posted : May 5, 2010
Results First Posted : April 8, 2016
Last Update Posted : September 15, 2016
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Multiple Sclerosis, Relapsing-Remitting
Interventions Biological: abatacept
Drug: Placebo
Enrollment 65
Recruitment Details Participants with relapsing-remitting multiple sclerosis were recruited from 21 sites in the US and Canada between November 2010 and November 2013
Pre-assignment Details  
Arm/Group Title Abatacept First, Then Placebo Placebo First, Then Abatacept
Hide Arm/Group Description 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. 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.
Period Title: Core Phase
Started 44 21
Completed 39 20
Not Completed 5 1
Reason Not Completed
Adverse Event             0             1
Lost to Follow-up             1             0
Withdrawal by Subject             3             0
Worsening Multiple Sclerosis             1             0
Period Title: Extension Phase
Started 38 [1] 20
Completed 29 18
Not Completed 9 2
Reason Not Completed
Adverse Event             1             1
Lost to Follow-up             2             0
Withdrawal by Subject             5             1
Not using appropriate birth control             1             0
[1]
One participant that completed core phase did not meet eligibility for Extension Phase
Arm/Group Title Abatacept First, Then Placebo Placebo First, Then Abatacept Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 44 21 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 21 participants 65 participants
40.5  (9.7) 42.7  (11.0) 41.2  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 21 participants 65 participants
Female
32
  72.7%
18
  85.7%
50
  76.9%
Male
12
  27.3%
3
  14.3%
15
  23.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 21 participants 65 participants
Hispanic or Latino
2
   4.5%
1
   4.8%
3
   4.6%
Not Hispanic or Latino
41
  93.2%
20
  95.2%
61
  93.8%
Unknown or Not Reported
1
   2.3%
0
   0.0%
1
   1.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 21 participants 65 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  15.9%
5
  23.8%
12
  18.5%
White
35
  79.5%
16
  76.2%
51
  78.5%
More than one race
1
   2.3%
0
   0.0%
1
   1.5%
Unknown or Not Reported
1
   2.3%
0
   0.0%
1
   1.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 21 participants 65 participants
Canada 41 19 60
United States 3 2 5
Baseline Expanded Disability Status Scale (EDSS) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants 21 participants 65 participants
2.0  (1.3) 2.4  (1.2) 2.1  (1.3)
[1]
Measure Description: Baseline EDSS score was the lowest score observed at either visit -2 (Wk -5) or visit -1 (Wk -1). The 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 Multiple Sclerosis Functional Composite (MSFC) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 44 participants 21 participants 65 participants
-0.01  (0.68) 0.03  (0.81) 0.00  (0.72)
[1]
Measure Description: Baseline MSFC score was the most recent score on or before Randomization. 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). 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 less severity of multiple sclerosis while negative scores indicate more severe multiple sclerosis symptoms.
Baseline Gd-enhanced Lesions   [1] 
Mean (Standard Deviation)
Unit of measure:  Lesions
Number Analyzed 44 participants 21 participants 65 participants
0.7  (1.4) 3.8  (10.7) 1.7  (6.3)
[1]
Measure Description: Number of gadolinium (Gd)-enhancing lesions detected during an MRI scan. Baseline MRI evaluations were obtained at Visit -1 (Wk -1). Gd-enhancing lesions are measured on T1 weighted images after injection of 0.1 mM/kg of gadolinium pentate. A higher score indicates more severe multiple sclerosis.
Baseline T2 Lesion Volume   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm^3
Number Analyzed 44 participants 21 participants 65 participants
6.7  (8.1) 9.6  (9.0) 7.7  (8.5)
[1]
Measure Description: Total volume of all T2 lesions detected during an MRI scan. Baseline MRI evaluations were obtained at Visit -1 (Wk -1). 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.
1.Primary Outcome
Title Mean Number of New Inflammatory MRI Lesions Per Monthly Scans
Hide Description 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.
Time Frame Weeks 8-24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Abatacept First, Then Placebo Placebo First, Then Abatacept
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 42 20
Mean (Standard Deviation)
Unit of Measure: New Lesions
0.4  (0.9) 1.7  (3.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept First, Then Placebo, Placebo First, Then Abatacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments Analysis was stratified on the presence or absence of subclinical activity as demonstrated by a Gd-enhanced lesion on one MRI in the past year prior to enrollment.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Absolute Number of New Inflammatory MRI Lesions on Monthly Scans
Hide Description 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.
Time Frame Weeks 4-24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Abatacept First, Then Placebo Placebo First, Then Abatacept
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 42 20
Mean (Standard Deviation)
Unit of Measure: New Lesions
2.3  (4.1) 9.1  (18.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept First, Then Placebo, Placebo First, Then Abatacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments Wilcoxon rank sum test in which the total number of new lesions were converted to ranks and then compared between groups
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Lesion Volume Accumulation on T2-weighted MRI Scans Over 24 Weeks
Hide Description 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.
Time Frame Week -1 to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population that did not terminate study prior to Week 24
Arm/Group Title Abatacept First, Then Placebo Placebo First, Then Abatacept
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 39 19
Mean (Standard Deviation)
Unit of Measure: cm^3
-0.05  (0.42) -0.18  (1.27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept First, Then Placebo, Placebo First, Then Abatacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments Rank sum test in which the lesion volume change values per participant were converted to ranks and compared between the treatment groups
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Percent Brain Volume Change
Hide Description 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.
Time Frame Week -1 to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population that did not terminate study prior to Week 24 and had MRI scans at both Week -1 and Week 24
Arm/Group Title Abatacept First, Then Placebo Placebo First, Then Abatacept
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 39 18
Mean (Standard Deviation)
Unit of Measure: percent change
-0.09  (0.54) -0.25  (0.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept First, Then Placebo, Placebo First, Then Abatacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments Wilcoxon rank sum test in which percent brain volume change values per participant were converted to ranks and the ranks were compared between groups
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Mean Number of New Inflammatory Lesions in 8-week Intervals
Hide Description 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.
Time Frame Week 8 to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Abatacept First, Then Placebo Placebo First, Then Abatacept
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 42 20
Mean (Standard Deviation)
Unit of Measure: New Lesions
0.5  (1.2) 2.2  (4.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept First, Then Placebo, Placebo First, Then Abatacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments Wilcoxon rank sum test in which mean numbers of new lesions per participant were converted to ranks and compared between groups
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants Progressing on the EDSS Scale by at Least 1 Point
Hide Description 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).
Time Frame Week -1 to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Abatacept First, Then Placebo Placebo First, Then Abatacept
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 42 20
Measure Type: Number
Unit of Measure: participants
5 1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept First, Then Placebo, Placebo First, Then Abatacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Annualized Relapse Rate
Hide Description 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.
Time Frame Week -1 to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Abatacept First, Then Placebo Placebo First, Then Abatacept
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 42 20
Measure Type: Number
Unit of Measure: Relapse Rate by Year
0.13 0.09
8.Secondary Outcome
Title Mean Change in the MSFC Over 24 Weeks of Treatment
Hide Description 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.
Time Frame Week -1 to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Abatacept First, Then Placebo Placebo First, Then Abatacept
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 42 20
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.10  (0.30) -0.04  (0.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept First, Then Placebo, Placebo First, Then Abatacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments Wilcoxon rank sum test in which the change from baseline scores per subject were converted to ranks and compared between treatment groups
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Mean Number of New Inflammatory MRI Lesions Per Scan During the Extension Phase
Hide Description 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.
Time Frame Weeks 36 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat in Extension Phase
Arm/Group Title Abatacept First, Then Placebo Placebo First, Then Abatacept
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 34 19
Mean (Standard Deviation)
Unit of Measure: New Lesions
1.3  (2.7) 0.6  (1.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept First, Then Placebo, Placebo First, Then Abatacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments Analysis was stratified on the presence or absence of subclinical activity as demonstrated by a Gd-enhanced lesion on one MRI in the past year prior to enrollment.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Lesion Volume Accumulation on T2-Weighted MRI Scans Between 24 Weeks and 52 Weeks
Hide Description 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.
Time Frame Week 24 to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat in Extension Phase who had an MRI at Week 52
Arm/Group Title Abatacept First, Then Placebo Placebo First, Then Abatacept
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 26 16
Mean (Standard Deviation)
Unit of Measure: cm^3
0.47  (0.99) 0.07  (1.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept First, Then Placebo, Placebo First, Then Abatacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments Rank sum test in which the lesion volume change values per participant were converted to ranks and compared between the treatment groups
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Secondary Outcome
Title Percent Brain Volume Change Between 24 Weeks and 52 Weeks
Hide Description 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.
Time Frame Week 24 to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat in Extension Phase who had an MRI at Week 52 with data to contribute to brain volume measurements
Arm/Group Title Abatacept First, Then Placebo Placebo First, Then Abatacept
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 24 16
Mean (Standard Deviation)
Unit of Measure: Percent change
-0.28  (0.42) -0.31  (0.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept First, Then Placebo, Placebo First, Then Abatacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments Wilcoxon rank sum test in which the percent brain volume change values per participant were converted to ranks and compared between treatment groups
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Secondary Outcome
Title Number of Participants Progressing on the EDSS Scale by at Least 1 Point
Hide Description 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).
Time Frame Week 24 to Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat in Extension Phase
Arm/Group Title Abatacept First, Then Placebo Placebo First, Then Abatacept
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 34 19
Measure Type: Number
Unit of Measure: participants
1 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept First, Then Placebo, Placebo First, Then Abatacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
13.Secondary Outcome
Title Annualized Relapse in Extension Phase
Hide Description 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.
Time Frame Week 24 to Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat in Extension Phase
Arm/Group Title Abatacept First, Then Placebo Placebo First, Then Abatacept
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 34 19
Measure Type: Number
Unit of Measure: Relapse Rate by Year
0.38 0.16
14.Secondary Outcome
Title Mean Change in the MSFC in Extension Phase
Hide Description 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.
Time Frame Week 24 to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat in Extension Phase who Completed the MSFC at Week 52
Arm/Group Title Abatacept First, Then Placebo Placebo First, Then Abatacept
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 27 18
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.06  (0.21) -0.01  (0.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept First, Then Placebo, Placebo First, Then Abatacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments Wilcoxon rank sum test in which the change from baseline scores per participant were converted to ranks and compared between treatment groups
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame From enrollment until end of study (up to 64 weeks).
Adverse Event Reporting Description 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.
 
Arm/Group Title Core Phase: Abatacept -> Placebo Core Phase: Placebo -> Abatacept Extension Phase: Abatacept -> Placebo Extension Phase: Placebo -> Abatacept Follow-up Phase: Abatacept -> Placebo Follow-up Phase: Placebo -> Abatacept
Hide Arm/Group Description

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.
Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. 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.

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.
Following Week 52, participants in the Abatacept -> Placebo group completed an additional 12 weeks of observation until week 64. Following Week 52, participants in the Placebo -> Abatacept group completed an additional 12 weeks of observation until week 64.
All-Cause Mortality
Core Phase: Abatacept -> Placebo Core Phase: Placebo -> Abatacept Extension Phase: Abatacept -> Placebo Extension Phase: Placebo -> Abatacept Follow-up Phase: Abatacept -> Placebo Follow-up Phase: Placebo -> Abatacept
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Core Phase: Abatacept -> Placebo Core Phase: Placebo -> Abatacept Extension Phase: Abatacept -> Placebo Extension Phase: Placebo -> Abatacept Follow-up Phase: Abatacept -> Placebo Follow-up Phase: Placebo -> Abatacept
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/44 (4.55%)      0/21 (0.00%)      2/37 (5.41%)      0/19 (0.00%)      4/29 (13.79%)      1/18 (5.56%)    
Infections and infestations             
Herpes zoster  1  0/44 (0.00%)  0 0/21 (0.00%)  0 0/37 (0.00%)  0 0/19 (0.00%)  0 1/29 (3.45%)  1 0/18 (0.00%)  0
Herpes zoster ophthalmic  1  0/44 (0.00%)  0 0/21 (0.00%)  0 0/37 (0.00%)  0 0/19 (0.00%)  0 1/29 (3.45%)  1 0/18 (0.00%)  0
Injury, poisoning and procedural complications             
Burns second degree  1  0/44 (0.00%)  0 0/21 (0.00%)  0 0/37 (0.00%)  0 0/19 (0.00%)  0 0/29 (0.00%)  0 1/18 (5.56%)  1
Metabolism and nutrition disorders             
Type 1 diabetes mellitus  1  0/44 (0.00%)  0 0/21 (0.00%)  0 0/37 (0.00%)  0 0/19 (0.00%)  0 1/29 (3.45%)  1 0/18 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Back pain  1  1/44 (2.27%)  1 0/21 (0.00%)  0 0/37 (0.00%)  0 0/19 (0.00%)  0 0/29 (0.00%)  0 0/18 (0.00%)  0
Nervous system disorders             
Hypoaesthesia  1  1/44 (2.27%)  1 0/21 (0.00%)  0 0/37 (0.00%)  0 0/19 (0.00%)  0 0/29 (0.00%)  0 0/18 (0.00%)  0
Multiple sclerosis relapse  1  1/44 (2.27%)  2 0/21 (0.00%)  0 2/37 (5.41%)  2 0/19 (0.00%)  0 2/29 (6.90%)  2 0/18 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Core Phase: Abatacept -> Placebo Core Phase: Placebo -> Abatacept Extension Phase: Abatacept -> Placebo Extension Phase: Placebo -> Abatacept Follow-up Phase: Abatacept -> Placebo Follow-up Phase: Placebo -> Abatacept
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/44 (52.27%)      14/21 (66.67%)      17/37 (45.95%)      15/19 (78.95%)      1/29 (3.45%)      3/18 (16.67%)    
Eye disorders             
Vision blurred  1  1/44 (2.27%)  1 0/21 (0.00%)  0 1/37 (2.70%)  1 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Gastrointestinal disorders             
Abdominal pain lower  1  0/44 (0.00%)  0 1/21 (4.76%)  1 0/37 (0.00%)  0 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Constipation  1  1/44 (2.27%)  1 0/21 (0.00%)  0 1/37 (2.70%)  1 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Dysphagia  1  0/44 (0.00%)  0 0/21 (0.00%)  0 0/37 (0.00%)  0 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
General disorders             
Fatigue  1  5/44 (11.36%)  5 4/21 (19.05%)  4 1/37 (2.70%)  1 0/19 (0.00%)  0 0/29 (0.00%)  0 0/18 (0.00%)  0
Influenza like illness  1  0/44 (0.00%)  0 0/21 (0.00%)  0 0/37 (0.00%)  0 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Oedema peripheral  1  0/44 (0.00%)  0 0/21 (0.00%)  0 0/37 (0.00%)  0 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Infections and infestations             
Bronchitis  1  1/44 (2.27%)  1 0/21 (0.00%)  0 2/37 (5.41%)  2 0/19 (0.00%)  0 0/29 (0.00%)  0 0/18 (0.00%)  0
Conjunctivitis infective  1  0/44 (0.00%)  0 0/21 (0.00%)  0 0/37 (0.00%)  0 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Respiratory tract infection  1  0/44 (0.00%)  0 0/21 (0.00%)  0 0/37 (0.00%)  0 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Sinusitis  1  0/44 (0.00%)  0 0/21 (0.00%)  0 1/37 (2.70%)  1 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Upper respiratory tract infection  1  5/44 (11.36%)  8 2/21 (9.52%)  2 0/37 (0.00%)  0 0/19 (0.00%)  0 0/29 (0.00%)  0 0/18 (0.00%)  0
Urinary tract infection  1  4/44 (9.09%)  5 3/21 (14.29%)  5 0/37 (0.00%)  0 2/19 (10.53%)  2 0/29 (0.00%)  0 0/18 (0.00%)  0
Investigations             
Blood cholesterol increased  1  0/44 (0.00%)  0 0/21 (0.00%)  0 0/37 (0.00%)  0 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Lymphocyte count decreased  1  0/44 (0.00%)  0 0/21 (0.00%)  0 0/37 (0.00%)  0 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Mean cell haemoglobin concentration decreased  1  1/44 (2.27%)  1 0/21 (0.00%)  0 2/37 (5.41%)  2 2/19 (10.53%)  2 0/29 (0.00%)  0 1/18 (5.56%)  1
Neutrophil count decreased  1  1/44 (2.27%)  2 0/21 (0.00%)  0 2/37 (5.41%)  2 0/19 (0.00%)  0 0/29 (0.00%)  0 0/18 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Muscle spasms  1  1/44 (2.27%)  1 0/21 (0.00%)  0 2/37 (5.41%)  2 0/19 (0.00%)  0 0/29 (0.00%)  0 0/18 (0.00%)  0
Pain in extremity  1  2/44 (4.55%)  2 0/21 (0.00%)  0 2/37 (5.41%)  2 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Nervous system disorders             
Balance disorder  1  1/44 (2.27%)  1 0/21 (0.00%)  0 0/37 (0.00%)  0 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Cognitive disorder  1  0/44 (0.00%)  0 0/21 (0.00%)  0 0/37 (0.00%)  0 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Headache  1  5/44 (11.36%)  11 4/21 (19.05%)  5 4/37 (10.81%)  4 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Hypoaesthesia  1  3/44 (6.82%)  4 1/21 (4.76%)  1 2/37 (5.41%)  2 2/19 (10.53%)  2 1/29 (3.45%)  1 0/18 (0.00%)  0
Multiple sclerosis relapse  1  2/44 (4.55%)  2 2/21 (9.52%)  2 3/37 (8.11%)  3 1/19 (5.26%)  1 0/29 (0.00%)  0 1/18 (5.56%)  1
Muscle spasticity  1  0/44 (0.00%)  0 0/21 (0.00%)  0 0/37 (0.00%)  0 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Paraesthesia  1  2/44 (4.55%)  2 1/21 (4.76%)  1 1/37 (2.70%)  1 0/19 (0.00%)  0 0/29 (0.00%)  0 1/18 (5.56%)  1
Sciatica  1  0/44 (0.00%)  0 1/21 (4.76%)  1 2/37 (5.41%)  2 0/19 (0.00%)  0 0/29 (0.00%)  0 0/18 (0.00%)  0
Trigeminal neuralgia  1  0/44 (0.00%)  0 0/21 (0.00%)  0 0/37 (0.00%)  0 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Psychiatric disorders             
Anxiety  1  0/44 (0.00%)  0 0/21 (0.00%)  0 0/37 (0.00%)  0 0/19 (0.00%)  0 0/29 (0.00%)  0 1/18 (5.56%)  1
Depression  1  1/44 (2.27%)  1 2/21 (9.52%)  2 2/37 (5.41%)  2 0/19 (0.00%)  0 0/29 (0.00%)  0 0/18 (0.00%)  0
Insomnia  1  0/44 (0.00%)  0 0/21 (0.00%)  0 3/37 (8.11%)  3 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Reproductive system and breast disorders             
Postmenopausal haemorrhage  1  0/44 (0.00%)  0 1/21 (4.76%)  1 0/37 (0.00%)  0 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Nasal congestion  1  1/44 (2.27%)  1 2/21 (9.52%)  2 1/37 (2.70%)  1 0/19 (0.00%)  0 0/29 (0.00%)  0 0/18 (0.00%)  0
Rhonchi  1  0/44 (0.00%)  0 0/21 (0.00%)  0 0/37 (0.00%)  0 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Vascular disorders             
Hypertension  1  1/44 (2.27%)  1 1/21 (4.76%)  1 0/37 (0.00%)  0 1/19 (5.26%)  1 0/29 (0.00%)  0 0/18 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
Phone: 301-594-7669
EMail: DAITClinicalTrialsGov@niaid.nih.gov
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01116427    
Other Study ID Numbers: DAIT ITN035AI
First Submitted: May 3, 2010
First Posted: May 5, 2010
Results First Submitted: December 15, 2015
Results First Posted: April 8, 2016
Last Update Posted: September 15, 2016