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Trial record 1 of 1 for:    IM101-603
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A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02915159
Recruitment Status : Completed
First Posted : September 26, 2016
Results First Posted : January 2, 2020
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Sjogrens Disease
Interventions Biological: Abatacept
Other: Placebo
Enrollment 250
Recruitment Details  
Pre-assignment Details 250 enrolled; 188 Randomized, 62 not Randomized:Reasons Not randomized: 6 withdrew consent, 1 lost to follow-up, 49 no longer meet study criteria, 6 screening failures
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description SC injection 125mg/mL in 1 mL pre-filled syringe SC injection in 1 mL pre-filled syringe
Period Title: Overall Study
Started 92 95
Completed 81 87
Not Completed 11 8
Reason Not Completed
Participant no longer meets criteria             2             0
poor/non-compliance             1             0
Participant withdrew consent             5             1
Request to discontinue treatment             1             2
Adverse Event             2             2
Lack of Efficacy             0             3
Arm/Group Title Abatacept Placebo Total
Hide Arm/Group Description SC injection 125mg/mL in 1 mL pre-filled syringe SC injection in 1 mL pre-filled syringe Total of all reporting groups
Overall Number of Baseline Participants 92 95 187
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants 95 participants 187 participants
51.2  (12.3) 52.9  (13.5) 52.0  (12.9)
Age, Customized   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 95 participants 187 participants
< 65 years
80
  87.0%
73
  76.8%
153
  81.8%
≥ 65 years
12
  13.0%
22
  23.2%
34
  18.2%
≤ 50 years
42
  45.7%
42
  44.2%
84
  44.9%
> 50 years
50
  54.3%
53
  55.8%
103
  55.1%
[1]
Measure Description: Categorical Age Dispersion
[2]
Measure Analysis Population Description: Total Participants will = 187 total participants, when the two values assessing the variation in the 65 years group are summed up as well as the two values assessing the variation in the 50 years group are summed up.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 95 participants 187 participants
Female
85
  92.4%
92
  96.8%
177
  94.7%
Male
7
   7.6%
3
   3.2%
10
   5.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 95 participants 187 participants
Hispanic or Latino
2
   2.2%
5
   5.3%
7
   3.7%
Not Hispanic or Latino
10
  10.9%
13
  13.7%
23
  12.3%
Unknown or Not Reported
80
  87.0%
77
  81.1%
157
  84.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 95 participants 187 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
21
  22.8%
23
  24.2%
44
  23.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  10.9%
9
   9.5%
19
  10.2%
White
60
  65.2%
60
  63.2%
120
  64.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.1%
3
   3.2%
4
   2.1%
1.Primary Outcome
Title Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
Hide Description

The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain.

The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm.

Domain: (Score) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2)

(No = No Disease Activity (DA), Low = Low DA, Moderate = Moderate DA, High = High DA)

Overall score, which can range from 0 to 123, a higher score indicates more disease activity

Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-treat (ITT) analysis population: all randomized participants who receive at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Subcutaneous (SC) injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
-3.2
(-4.6 to -1.9)
-3.7
(-5.0 to -2.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4421
Comments [Not Specified]
Method longitudinal repeated measures analysis
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI)
Hide Description

The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components.

Total Score Range (0 = Best outcome and 10 = Worst Outcome)

The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.

Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
-1.26
(-1.88 to -0.64)
-1.52
(-2.12 to -0.93)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3367
Comments [Not Specified]
Method longitudinal repeated measures analysis
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the Stimulated Whole Salivary Flow
Hide Description The mean change from baseline in the stimulated whole salivary flow at Day 169
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT Population with Stimulated Whole Salivary Flow of at Least 0.1 mL/min at Both Screening and Baseline
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 88 88
Mean (95% Confidence Interval)
Unit of Measure: mL/min
0.057
(-0.115 to 0.230)
0.108
(-0.060 to 0.276)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .5841
Comments [Not Specified]
Method longitudinal repeated measures analysis
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population
Hide Description

The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm.

DAS28-CRP = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(hsCRP+1) + 0.014 * VAS + 0.96.

(sqrt = Square root, ln = natural log)

Positive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity

Time Frame Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Day 29 Number Analyzed 86 participants 88 participants
-0.4
(-0.6 to -0.2)
-0.4
(-0.6 to -0.2)
Day 57 Number Analyzed 84 participants 90 participants
-0.6
(-0.8 to -0.4)
-0.7
(-0.9 to -0.4)
Day 85 Number Analyzed 83 participants 86 participants
-0.8
(-1.0 to -0.6)
-0.8
(-1.1 to -0.6)
Day 113 Number Analyzed 81 participants 85 participants
-0.8
(-1.0 to -0.5)
-1.0
(-1.2 to -0.7)
Day 141 Number Analyzed 80 participants 88 participants
-0.8
(-1.0 to -0.5)
-1.0
(-1.3 to -0.8)
Day 169 Number Analyzed 79 participants 85 participants
-0.9
(-1.1 to -0.6)
-1.1
(-1.4 to -0.9)
5.Secondary Outcome
Title Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3
Hide Description

The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm.

DAS28-CRP = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(hsCRP+1) + 0.014 * VAS + 0.96.

(sqrt = Square root, ln = natural log)

Positive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity

Time Frame Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT Population with Baseline Tender plus Swollen Joint Count of at Least 3
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 57 63
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Day 29 Number Analyzed 52 participants 58 participants
-0.5
(-0.8 to -0.2)
-0.6
(-0.9 to -0.3)
Day 57 Number Analyzed 50 participants 60 participants
-0.9
(-1.2 to -0.5)
-1.0
(-1.3 to -0.6)
Day 85 Number Analyzed 50 participants 57 participants
-1.1
(-1.5 to -0.7)
-1.2
(-1.5 to -0.8)
Day 113 Number Analyzed 48 participants 57 participants
-1.1
(-1.4 to -0.7)
-1.4
(-1.7 to -1.0)
Day 141 Number Analyzed 48 participants 59 participants
-1.2
(-1.5 to -0.8)
-1.5
(-1.8 to -1.1)
Day 169 Number Analyzed 47 participants 57 participants
-1.3
(-1.7 to -0.9)
-1.5
(-1.9 to -1.2)
6.Secondary Outcome
Title Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3
Hide Description

The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm.

DAS28-CRP = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(hsCRP+1) + 0.014 * VAS + 0.96.

(sqrt = Square root, ln = natural log)

Positive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity

Time Frame Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT Population with Baseline Tender plus Swollen Joint Count of Less than 3
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 35 31
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Day 29 Number Analyzed 34 participants 30 participants
-0.3
(-0.6 to 0.0)
-0.2
(-0.6 to 0.1)
Day 57 Number Analyzed 34 participants 30 participants
-0.2
(-0.5 to 0.1)
-0.2
(-0.5 to 0.1)
Day 85 Number Analyzed 33 participants 29 participants
-0.4
(-0.6 to -0.1)
-0.4
(-0.7 to -0.1)
Day 113 Number Analyzed 33 participants 28 participants
-0.3
(-0.6 to -0.0)
-0.3
(-0.6 to -0.1)
Day 141 Number Analyzed 32 participants 29 participants
-0.2
(-0.5 to 0.1)
-0.4
(-0.7 to -0.0)
Day 169 Number Analyzed 32 participants 28 participants
-0.3
(-0.5 to -0.0)
-0.5
(-0.7 to -0.2)
7.Secondary Outcome
Title Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population
Hide Description

The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.

Tender Joint: Count 1-28 Swollen Joint: Count 1-28

Negative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted

Time Frame Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (ITT)
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (95% Confidence Interval)
Unit of Measure: Joint Count
Day 29 - Tender Joint Number Analyzed 90 participants 90 participants
-1.7
(-2.8 to -0.7)
-1.9
(-2.9 to -0.8)
Day 29 - Swollen Joint Number Analyzed 90 participants 90 participants
-0.5
(-1.0 to 0.1)
-0.6
(-1.1 to -0.1)
Day 57 - Tender Joint Number Analyzed 87 participants 92 participants
-2.6
(-3.7 to -1.5)
-2.9
(-4.0 to -1.9)
Day 57 - Swollen Joint Number Analyzed 87 participants 92 participants
-1.0
(-1.6 to -0.3)
-1.0
(-1.6 to -0.4)
Day 85 - Tender Joint Number Analyzed 85 participants 89 participants
-2.9
(-4.1 to -1.7)
-3.4
(-4.6 to -2.2)
Day 85 - Swollen Joint Number Analyzed 85 participants 89 participants
-1.4
(-2.0 to -0.8)
-1.4
(-2.0 to -0.9)
Day 113 - Tender Joint Number Analyzed 83 participants 87 participants
-3.1
(-4.2 to -2.0)
-3.9
(-5.0 to -2.8)
Day 113 - Swollen Joint Number Analyzed 83 participants 87 participants
-1.5
(-2.0 to -1.1)
-1.9
(-2.3 to -1.4)
Day 141 - Tender Joint Number Analyzed 82 participants 89 participants
-3.6
(-4.7 to -2.5)
-4.1
(-5.2 to -3.0)
Day 141 - Swollen Joint Number Analyzed 82 participants 89 participants
-1.4
(-1.9 to -0.8)
-1.8
(-2.4 to -1.3)
Day 169 - Tender Joint Number Analyzed 81 participants 87 participants
-2.9
(-4.0 to -1.7)
-4.4
(-5.6 to -3.3)
Day 169 - Swollen Joint Number Analyzed 81 participants 87 participants
-1.4
(-1.9 to -0.8)
-2.0
(-2.6 to -1.5)
8.Secondary Outcome
Title Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population
Hide Description

The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.

CRP: measured lab value

Positive Number = Increased level of CRP Negative Number = Reduced Level of CRP

Time Frame Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (ITT)
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (95% Confidence Interval)
Unit of Measure: mg/L
Day 29 - CRP Number Analyzed 87 participants 90 participants
0.3
(-1.4 to 2.0)
0.6
(-1.0 to 2.3)
Day 57 - CRP Number Analyzed 85 participants 91 participants
-0.1
(-2.1 to 1.8)
1.8
(-0.1 to 3.6)
Day 85 - CRP Number Analyzed 83 participants 88 participants
-0.2
(-5.0 to 4.5)
3.0
(-1.6 to 7.6)
Day 113 - CRP Number Analyzed 81 participants 86 participants
1.6
(-0.8 to 4.1)
0.3
(-2.1 to 2.6)
Day 141 - CRP Number Analyzed 80 participants 89 participants
3.5
(-1.7 to 8.8)
-0.2
(-5.2 to 4.7)
Day 169 - CRP Number Analyzed 79 participants 86 participants
-0.2
(-1.8 to 1.3)
0.0
(-1.5 to 1.5)
9.Secondary Outcome
Title Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population
Hide Description

The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.

Assesment of Disease Activity: 0-100 scale [100=Most severe]

Positive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity

Time Frame Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (ITT)
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (95% Confidence Interval)
Unit of Measure: Scores on a Scale
Day 29 - Assessment of Disease Activity Number Analyzed 89 participants 92 participants
-4.0
(-9.8 to 1.7)
-7.1
(-12.7 to -1.4)
Day 57 - Assessment of Disease Activity Number Analyzed 86 participants 93 participants
-7.5
(-13.4 to -1.7)
-6.3
(-11.9 to -0.6)
Day 85 - Assessment of Disease Activity Number Analyzed 85 participants 89 participants
-10.4
(-16.3 to -4.4)
-10.2
(-16.0 to -4.4)
Day 113 - Assessment of Disease Activity Number Analyzed 83 participants 88 participants
-8.0
(-14.0 to -2.0)
-9.7
(-15.5 to -3.9)
Day 141 - Assessment of Disease Activity Number Analyzed 82 participants 90 participants
-5.1
(-11.0 to 0.8)
-11.0
(-16.7 to -5.3)
Day 169 - Assessment of Disease Activity Number Analyzed 81 participants 88 participants
-10.1
(-16.1 to -4.0)
-9.0
(-14.8 to -3.1)
10.Secondary Outcome
Title Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3
Hide Description

The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.

Tender Joint: Count 1-28 Swollen Joint: Count 1-28

Negative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted

Time Frame Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of at least 3
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 57 63
Mean (95% Confidence Interval)
Unit of Measure: Joint Count
Day 29 - Tender Joint Number Analyzed 55 participants 60 participants
-2.8
(-4.5 to -1.0)
-3.0
(-4.7 to -1.3)
Day 29 - Swollen Joint Number Analyzed 55 participants 60 participants
-0.7
(-1.5 to 0.2)
-0.9
(-1.7 to -0.1)
Day 57 - Tender Joint Number Analyzed 53 participants 62 participants
-4.1
(-5.9 to -2.3)
-4.8
(-6.5 to -3.0)
Day 57 - Swollen Joint Number Analyzed 53 participants 62 participants
-1.5
(-2.6 to -0.5)
-1.6
(-2.6 to -0.5)
Day 85 - Tender Joint Number Analyzed 52 participants 59 participants
-4.4
(-6.3 to -2.4)
-5.4
(-7.2 to -3.6)
Day 85 - Swollen Joint Number Analyzed 52 participants 59 participants
-2.1
(-3.1 to -1.1)
-2.2
(-3.2 to -1.3)
Day 113 - Tender Joint Number Analyzed 50 participants 58 participants
-4.8
(-6.6 to -2.9)
-6.0
(-7.7 to -4.2)
Day 113 - Swollen Joint Number Analyzed 50 participants 58 participants
-2.3
(-3.2 to -1.5)
-2.9
(-3.7 to -2.2)
Day 141 - Tender Joint Number Analyzed 50 participants 60 participants
-5.7
(-7.5 to -3.8)
-6.4
(-8.2 to -4.7)
Day 141 - Swollen Joint Number Analyzed 50 participants 60 participants
-2.2
(-3.1 to -1.3)
-3.0
(-3.8 to -2.1)
Day 169 - Tender Joint Number Analyzed 49 participants 58 participants
-4.6
(-6.5 to -2.7)
-6.7
(-8.5 to -4.9)
Day 169 - Swollen Joint Number Analyzed 49 participants 58 participants
-2.2
(-3.1 to -1.3)
-3.1
(-4.0 to -2.3)
11.Secondary Outcome
Title Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3
Hide Description

The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.

CRP: measured lab value

Positive Number = Increased level of CRP Negative Number = Reduced Level of CRP

Time Frame Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of at least 3
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 57 63
Mean (95% Confidence Interval)
Unit of Measure: mg/L
Day 29 - CRP Number Analyzed 53 participants 59 participants
-1.5
(-3.7 to 0.7)
-0.7
(-2.8 to 1.4)
Day 57 - CRP Number Analyzed 51 participants 60 participants
-1.3
(-4.3 to 1.7)
1.3
(-1.5 to 4.0)
Day 85 - CRP Number Analyzed 50 participants 57 participants
-2.2
(-9.8 to 5.5)
3.8
(-3.4 to 11.0)
Day 113 - CRP Number Analyzed 48 participants 57 participants
1.2
(-2.7 to 5.1)
-0.4
(-4.0 to 3.2)
Day 141 - CRP Number Analyzed 48 participants 59 participants
4.5
(-4.0 to 12.9)
-1.4
(-9.0 to 6.3)
Day 169 - CRP Number Analyzed 47 participants 57 participants
-1.4
(-3.9 to 1.1)
-0.7
(-3.0 to 1.6)
12.Secondary Outcome
Title Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3
Hide Description

The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.

Assesment of Disease Activity: 0-100 scale [100=Most severe]

Positive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity

Time Frame Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of at least 3
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 57 63
Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
Day 29 - Assessment of Disease Activity Number Analyzed 54 participants 61 participants
0.6
(-6.9 to 8.1)
-3.5
(-10.7 to 3.7)
Day 57 - Assessment of Disease Activity Number Analyzed 52 participants 62 participants
-3.5
(-11.5 to 4.5)
-6.5
(-14.0 to 1.1)
Day 85 - Assessment of Disease Activity Number Analyzed 52 participants 59 participants
-7.5
(-15.5 to 0.4)
-7.7
(-15.3 to -0.1)
Day 113 - Assessment of Disease Activity Number Analyzed 50 participants 58 participants
-6.6
(-14.4 to 1.3)
-9.1
(-16.5 to -1.6)
Day 141 - Assessment of Disease Activity Number Analyzed 50 participants 60 participants
-1.2
(-9.0 to 6.7)
-8.1
(-15.5 to -0.7)
Day 169 - Assessment of Disease Activity Number Analyzed 49 participants 58 participants
-6.7
(-14.9 to 1.5)
-7.8
(-15.5 to -0.0)
13.Secondary Outcome
Title Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3
Hide Description

The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.

Tender Joint: Count 1-28 Swollen Joint: Count 1-28

Negative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted

Time Frame Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of Less than 3
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 35 31
Mean (95% Confidence Interval)
Unit of Measure: Joint Count
Day 29 - Tender Joint Number Analyzed 35 participants 30 participants
-0.1
(-0.9 to 0.6)
-0.2
(-0.9 to 0.6)
Day 29 - Swollen Joint Number Analyzed 35 participants 30 participants
0.1
(-0.2 to 0.3)
0.1
(-0.2 to 0.4)
Day 57 - Tender Joint Number Analyzed 34 participants 30 participants
-0.2
(-0.9 to 0.6)
0.1
(-0.6 to 0.9)
Day 57 - Swollen Joint Number Analyzed 34 participants 30 participants
0.2
(-0.1 to 0.4)
0.0
(-0.2 to 0.3)
Day 85 - Tender Joint Number Analyzed 33 participants 30 participants
-0.5
(-1.3 to 0.2)
0.1
(-0.7 to 0.8)
Day 85 - Swollen Joint Number Analyzed 33 participants 30 participants
-0.0
(-0.3 to 0.2)
0.1
(-0.2 to 0.4)
Day 113 - Tender Joint Number Analyzed 33 participants 29 participants
-0.4
(-1.2 to 0.3)
-0.5
(-1.3 to 0.3)
Day 113 - Swollen Joint Number Analyzed 33 participants 29 participants
0.0
(-0.3 to 0.3)
0.1
(-0.2 to 0.4)
Day 141 - Tender Joint Number Analyzed 32 participants 29 participants
-0.2
(-1.0 to 0.6)
-0.2
(-1.0 to 0.6)
Day 141 - Swollen Joint Number Analyzed 32 participants 29 participants
0.2
(-0.1 to 0.5)
0.3
(0.0 to 0.6)
Day 169 - Tender Joint Number Analyzed 32 participants 29 participants
-0.1
(-0.9 to 0.7)
-0.7
(-1.4 to 0.1)
Day 169 - Swollen Joint Number Analyzed 32 participants 29 participants
0.2
(-0.1 to 0.5)
-0.0
(-0.3 to 0.2)
14.Secondary Outcome
Title Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3
Hide Description

The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.

CRP: measured lab value

Positive Number = Increased level of CRP Negative Number = Reduced Level of CRP

Time Frame Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of Less than 3
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 35 31
Mean (95% Confidence Interval)
Unit of Measure: mg/L
Day 29 - CRP Number Analyzed 34 participants 30 participants
2.1
(-0.8 to 4.9)
1.8
(-1.2 to 4.7)
Day 57 - CRP Number Analyzed 34 participants 30 participants
0.5
(-2.3 to 3.4)
1.0
(-1.9 to 3.9)
Day 85 - CRP Number Analyzed 33 participants 30 participants
1.4
(-1.5 to 4.3)
0.1
(-2.8 to 3.1)
Day 113 - CRP Number Analyzed 33 participants 28 participants
1.3
(-1.6 to 4.1)
0.1
(-2.8 to 3.1)
Day 141 - CRP Number Analyzed 32 participants 29 participants
0.7
(-2.2 to 3.6)
0.8
(-2.1 to 3.8)
Day 169 - CRP Number Analyzed 32 participants 28 participants
0.2
(-2.7 to 3.1)
0.2
(-2.8 to 3.1)
15.Secondary Outcome
Title Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3
Hide Description

The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.

Assesment of Disease Activity: 0-100 scale [100=Most severe]

Positive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity

Time Frame Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of Less than 3
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 35 31
Mean (95% Confidence Interval)
Unit of Measure: Scores on a Scale
Day 29 - Assessment of Disease Activity Number Analyzed 35 participants 30 participants
-10.3
(-19.3 to -1.4)
-11.8
(-21.3 to -2.3)
Day 57 - Assessment of Disease Activity Number Analyzed 34 participants 30 participants
-12.4
(-21.4 to -3.4)
-4.8
(-14.3 to 4.7)
Day 85 - Assessment of Disease Activity Number Analyzed 33 participants 29 participants
-14.0
(-23.0 to -5.0)
-13.5
(-23.0 to -4.0)
Day 113 - Assessment of Disease Activity Number Analyzed 33 participants 29 participants
-9.1
(-18.1 to -0.0)
-11.1
(-20.6 to -1.5)
Day 141 - Assessment of Disease Activity Number Analyzed 32 participants 29 participants
-10.6
(-19.8 to -1.5)
-15.3
(-24.8 to -5.7)
Day 169 - Assessment of Disease Activity Number Analyzed 32 participants 29 participants
-13.8
(-23.0 to -4.6)
-10.9
(-20.5 to -1.4)
16.Secondary Outcome
Title Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points
Hide Description Proportion of participants who achieve a minimally clinically important change (of at least 3 points) in the ESSDAI at all measured time points up to Day 169.
Time Frame Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (ITT) Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
Day 29
37
(27.1 to 47.7)
34.7
(25.3 to 45.2)
Day 57
37
(27.1 to 47.7)
44.2
(34.0 to 54.8)
Day 85
48.9
(38.3 to 59.6)
50.5
(40.1 to 60.9)
Day 113
55.4
(44.7 to 65.8)
50.5
(40.1 to 60.9)
Day 141
51.1
(40.4 to 61.7)
56.8
(46.3 to 67.0)
Day 169
55.4
(44.7 to 65.8)
57.9
(47.3 to 68.0)
17.Secondary Outcome
Title Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points
Hide Description Proportion of participants who achieve a minimally clinically important change (of at least 5 points) in the ESSDAI at all measured time points up to Day 169.
Time Frame Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (ITT) Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
Day 29
19.6
(12.0 to 29.1)
13.7
(7.5 to 22.3)
Day 57
26.1
(17.5 to 36.3)
24.2
(16.0 to 34.1)
Day 85
34.8
(25.1 to 45.4)
32.6
(23.4 to 43.0)
Day 113
37.0
(27.1 to 47.7)
36.8
(27.2 to 47.4)
Day 141
37.0
(27.1 to 47.7)
36.8
(31.1 to 51.6)
Day 169
35.9
(26.1 to 46.5)
46.3
(36.0 to 56.8)
18.Secondary Outcome
Title Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point
Hide Description Proportion of participants who achieve a minimally clinically important change (of at least 1 point) in the ESSPRI at all measured time points up to Day 169.
Time Frame Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (ITT) Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
Day 29
31.5
(22.2 to 42.0)
38.9
(29.1 to 49.5)
Day 57
42.4
(32.1 to 53.1)
47.4
(37.0 to 57.9)
Day 85
44.6
(34.2 to 55.3)
55.8
(45.2 to 66.0)
Day 113
42.4
(32.1 to 53.1)
52.6
(42.1 to 63.0)
Day 141
40.2
(30.1 to 51.0)
54.7
(44.2 to 65.0)
Day 169
41.3
(31.1 to 52.1)
52.6
(42.1 to 63.0)
19.Secondary Outcome
Title Change From Baseline at All Measured Time Points in the ESSDAI
Hide Description

The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain.

The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm.

Domain: (Score) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2)

(No = No Disease Activity (DA), Low = Low DA, Moderate = Moderate DA, High = High DA)

Overall score, which can range from 0 to 123, a higher score indicates more disease activity

Time Frame Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (ITT) Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (95% Confidence Interval)
Unit of Measure: Percent Change from Baseline
Day 29 Number Analyzed 89 participants 92 participants
-10.9
(-22.3 to 0.54)
-12.6
(-23.71 to -1.39)
Day 57 Number Analyzed 85 participants 90 participants
-24.1
(-36.10 to -12.08)
-18.9
(-30.52 to -7.32)
Day 85 Number Analyzed 85 participants 90 participants
-26.0
(-38.81 to -13.17)
-25.4
(-37.76 to -13.01)
Day 113 Number Analyzed 83 participants 88 participants
-34.1
(-46.8 to -21.34)
-32.1
(-44.35 to -19.83)
Day 141 Number Analyzed 82 participants 89 participants
-29.7
(-43.02 to -16.31)
-37.0
(-49.81 to -24.12)
Day 169 Number Analyzed 81 participants 88 participants
-33.4
(-46.54 to -20.24)
-37.6
(-50.24 to -25.02)
20.Secondary Outcome
Title Change From Baseline at All Measured Time Points in the ESSPRI
Hide Description

The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components.

Total Score Range (0 = Best outcome and 10 = Worst Outcome)

The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.

Time Frame Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (ITT) Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
Day 29 Number Analyzed 90 participants 92 participants
-0.32
(-0.79 to 0.16)
-0.54
(-1.00 to -0.08)
Day 57 Number Analyzed 87 participants 93 participants
-0.81
(-1.32 to -0.31)
-0.82
(-1.31 to -0.33)
Day 85 Number Analyzed 85 participants 90 participants
-0.83
(-1.34 to -0.32)
-1.20
(-1.70 to -0.70)
Day 113 Number Analyzed 83 participants 88 participants
-0.79
(-1.32 to -0.26)
-1.37
(-1.88 to -0.86)
Day 141 Number Analyzed 82 participants 89 participants
-0.87
(-1.40 to -0.35)
-1.32
(-1.83 to -0.81)
Day 169 Number Analyzed 81 participants 88 participants
-1.03
(-1.55 to -0.50)
-1.30
(-1.80 to -0.79)
21.Secondary Outcome
Title Change From Baseline in Components of ESSDAI
Hide Description

The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain.

The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm.

Domain: (Score for activity level) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2)

(No = No Disease Activity, Low = Low Disease Activity, Moderate = Moderate Disease Activity, High = High Disease Activity)

Time Frame Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
Day 29: Constitutional Number Analyzed 89 participants 92 participants
-0.3
(-0.4 to -0.1)
-0.4
(-0.5 to -0.2)
Day 29: Lymphadenopathy Number Analyzed 89 participants 92 participants
-0.6
(-1.0 to -0.2)
-0.5
(-0.9 to -0.2)
Day 29: Glandular Number Analyzed 89 participants 92 participants
-0.2
(-0.4 to 0.0)
-0.2
(-0.4 to 0.0)
Day 29: Articular Number Analyzed 89 participants 91 participants
-0.4
(-0.8 to 0.0)
-0.3
(-0.7 to 0.1)
Day 29: Cutaneous Number Analyzed 89 participants 92 participants
-0.3
(-0.6 to -0.0)
-0.2
(-0.5 to 0.1)
Day 29: Pulmonary Number Analyzed 89 participants 92 participants
0.0
(-0.3 to 0.3)
0.1
(-0.2 to 0.4)
Day 29: Renal Number Analyzed 89 participants 92 participants
-0.0
(-0.2 to 0.2)
-0.2
(-0.3 to 0.0)
Day 29: Muscular Number Analyzed 89 participants 92 participants
-0.0
(-0.1 to 0.1)
-0.0
(-0.1 to 0.1)
Day 29: Peripheral Nervous System Number Analyzed 89 participants 92 participants
-0.0
(-0.2 to 0.2)
0.0
(-0.2 to 0.20)
Day 29: Haematogical Number Analyzed 89 participants 92 participants
0.2
(-0.0 to 0.4)
0.1
(-0.1 to 0.4)
Day 29: Biological Number Analyzed 89 participants 92 participants
0.1
(-0.1 to 0.2)
0.1
(-0.0 to 0.3)
Day 57: Constitutional Number Analyzed 85 participants 90 participants
-0.2
(-0.4 to -0.0)
-0.3
(-0.5 to -0.1)
Day 57: Lymphadenopathy Number Analyzed 85 participants 90 participants
-0.7
(-1.1 to -0.2)
-0.6
(-1.0 to -0.2)
Day 57: Glandular Number Analyzed 85 participants 90 participants
-0.4
(-0.7 to -0.2)
-0.4
(-0.6 to -0.1)
Day 57: Articular Number Analyzed 85 participants 90 participants
-0.7
(-1.1 to -0.3)
-0.8
(-1.2 to -0.4)
Day 57: Cutaneous Number Analyzed 85 participants 90 participants
-0.3
(-0.6 to -0.0)
-0.2
(-0.5 to 0.1)
Day 57: Pulmonary Number Analyzed 85 participants 90 participants
-0.0
(-0.3 to 0.3)
0.2
(-0.1 to 0.5)
Day 57: Renal Number Analyzed 85 participants 90 participants
-0.0
(-0.2 to 0.2)
-0.1
(-0.3 to 0.1)
Day 57: Muscular Number Analyzed 85 participants 89 participants
-0.0
(-0.1 to 0.1)
-0.1
(-0.2 to -0.0)
Day 57: Peripheral Nervous System Number Analyzed 85 participants 89 participants
-0.0
(-0.2 to 0.2)
0.0
(-0.2 to 0.2)
Day 57: Haematological Number Analyzed 85 participants 90 participants
0.1
(-0.1 to 0.4)
0.2
(-0.0 to 0.4)
Day 57: Biological Number Analyzed 81 participants 84 participants
-0.1
(-0.2 to 0.1)
0.0
(-0.1 to 0.2)
Day 85: Constitutional Number Analyzed 85 participants 90 participants
-0.3
(-0.5 to -0.1)
-0.4
(-0.6 to -0.2)
Day 85: Lymphadenopathy Number Analyzed 85 participants 90 participants
-0.7
(-1.1 to -0.3)
-0.8
(-1.2 to -0.4)
Day 85: Glandular Number Analyzed 85 participants 90 participants
-0.4
(-0.6 to -0.1)
-0.5
(-0.7 to -0.2)
Day 85: Articular Number Analyzed 85 participants 90 participants
-1.0
(-1.5 to -0.6)
-1.1
(-1.6 to -0.7)
Day 85: Cutaneous Number Analyzed 85 participants 90 participants
-0.4
(-0.7 to -0.0)
-0.2
(-0.5 to 0.1)
Day 85: Pulmonary Number Analyzed 85 participants 90 participants
0.0
(-0.3 to 0.4)
0.2
(-0.1 to 0.5)
Day 85: Renal Number Analyzed 85 participants 90 participants
-0.1
(-0.3 to 0.1)
-0.1
(-0.3 to 0.1)
Day 85: Muscular Number Analyzed 85 participants 90 participants
-0.1
(-0.2 to 0.0)
-0.0
(-0.1 to 0.1)
Day 85: Peripheral Nervous System Number Analyzed 85 participants 90 participants
-0.0
(-0.2 to 0.2)
0.0
(-0.2 to 0.2)
Day 85: Haematological Number Analyzed 85 participants 90 participants
0.1
(-0.1 to 0.3)
0.2
(-0.1 to 0.4)
Day 85: Biological Number Analyzed 85 participants 90 participants
0.0
(-0.1 to 0.2)
0.2
(0.0 to 0.3)
Day 113: Constitutional Number Analyzed 83 participants 88 participants
-0.3
(-0.5 to -0.0)
-0.3
(-0.5 to -0.1)
Day 113: Lymphadenopathy Number Analyzed 83 participants 88 participants
-0.8
(-1.2 to -0.4)
-0.9
(-1.3 to -0.5)
Day 113: Glandular Number Analyzed 83 participants 88 participants
-0.5
(-0.7 to -0.3)
-0.5
(-0.8 to -0.3)
Day 113: Articular Number Analyzed 83 participants 88 participants
-1.3
(-1.8 to -0.8)
-1.3
(-1.7 to -0.8)
Day 113: Cutaneous Number Analyzed 83 participants 88 participants
-0.4
(-0.7 to -0.1)
-0.4
(-0.7 to -0.1)
Day 113: Pulmonary Number Analyzed 83 participants 88 participants
0.0
(-0.3 to 0.4)
0.1
(-0.2 to 0.5)
Day 113: Renal Number Analyzed 83 participants 88 participants
-0.1
(-0.3 to 0.1)
0.0
(-0.2 to 0.2)
Day 113: Muscular Number Analyzed 83 participants 88 participants
-0.0
(-0.1 to 0.1)
-0.1
(-0.2 to 0.0)
Day 113: Peripheral Nervous System Number Analyzed 83 participants 88 participants
-0.0
(-0.2 to 0.2)
-0.0
(-0.2 to 0.1)
Day 113: Haematological Number Analyzed 83 participants 88 participants
0.1
(-0.2 to 0.3)
0.2
(-0.0 to 0.4)
Day 113: Biological Number Analyzed 83 participants 88 participants
-0.0
(-0.2 to 0.1)
0.1
(-0.0 to 0.3)
Day 141: Constitutional Number Analyzed 82 participants 89 participants
-0.2
(-0.4 to 0.0)
-0.4
(-0.6 to -0.2)
Day 141: Lymphadenopathy Number Analyzed 82 participants 89 participants
-0.6
(-1.1 to -0.2)
-0.9
(-1.4 to -0.5)
Day 141: Glandular Number Analyzed 82 participants 89 participants
-0.5
(-0.7 to -0.2)
-0.6
(-0.8 to -0.4)
Day 141: Articular Number Analyzed 82 participants 89 participants
-1.2
(-1.7 to -0.8)
-1.4
(-1.9 to -1.0)
Day 141: Cutaneous Number Analyzed 82 participants 89 participants
-0.4
(-0.7 to -0.1)
-0.5
(-0.8 to -0.3)
Day 141: Pulmonary Number Analyzed 82 participants 89 participants
-0.0
(-0.4 to 0.3)
0.1
(-0.2 to 0.4)
Day 141: Renal Number Analyzed 82 participants 89 participants
-0.0
(-0.2 to 0.2)
-0.1
(-0.3 to 0.1)
Day 141: Muscular Number Analyzed 82 participants 89 participants
-0.1
(-0.2 to 0.0)
-0.1
(-0.2 to 0.0)
Day 141: Peripheral Nervous System Number Analyzed 82 participants 89 participants
-0.1
(-0.3 to 0.1)
-0.0
(-0.2 to 0.1)
Day 141: Haematological Number Analyzed 82 participants 89 participants
0.1
(-0.1 to 0.4)
0.1
(-0.1 to 0.4)
Day 141: Biological Number Analyzed 80 participants 86 participants
-0.0
(-0.2 to 0.1)
0.1
(-0.0 to 0.2)
Day 169: Constitutional Number Analyzed 81 participants 88 participants
-0.3
(-0.5 to -0.1)
-0.4
(-0.6 to -0.2)
Day 169: Lymphadenopathy Number Analyzed 81 participants 88 participants
-0.9
(-1.3 to -0.5)
-1.1
(-1.4 to -0.7)
Day 169: Glandular Number Analyzed 81 participants 88 participants
-0.4
(-0.6 to -0.1)
-0.5
(-0.8 to -0.3)
Day 169: Articular Number Analyzed 81 participants 88 participants
-1.4
(-1.8 to -0.9)
-1.8
(-2.2 to -1.4)
Day 169: Cutaneous Number Analyzed 81 participants 88 participants
-0.3
(-0.7 to 0.0)
-0.5
(-0.9 to -0.2)
Day 169: Pulmonary Number Analyzed 81 participants 88 participants
-0.0
(-0.4 to 0.3)
0.1
(-0.2 to 0.4)
Day 169: Renal Number Analyzed 81 participants 88 participants
-0.0
(-0.2 to 0.2)
0.0
(-0.2 to 0.2)
Day 169: Muscular Number Analyzed 81 participants 88 participants
-0.0
(-0.1 to 0.1)
-0.1
(-0.2 to 0.0)
Day 169: Peripheral Nervous Number Analyzed 81 participants 88 participants
-0.1
(-0.3 to 0.1)
-0.0
(-0.2 to 0.2)
Day 169: Haematological Number Analyzed 81 participants 88 participants
0.1
(-0.2 to 0.3)
0.3
(0.1 to 0.5)
Day 169: Biological Number Analyzed 81 participants 88 participants
0.0
(-0.1 to 0.2)
0.2
(0.0 to 0.3)
22.Secondary Outcome
Title Change From Baseline in ESSPRI Components
Hide Description

The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components.

Total Score Range (0 = Best outcome and 10 = Worst Outcome)

The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.

Time Frame Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Modified ITT Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
Day 29: Dryness Score Number Analyzed 90 participants 92 participants
-0.21
(-0.76 to 0.34)
-0.26
(-0.80 to 0.28)
Day 29: Fatigue Score Number Analyzed 90 participants 92 participants
-0.57
(-1.18 to 0.03)
-1.01
(-1.60 to -0.42)
Day 29: Pain Score Number Analyzed 90 participants 92 participants
-0.34
(-0.96 to 0.27)
-0.53
(-1.13 to 0.07)
Day 57: Dryness Score Number Analyzed 87 participants 93 participants
-0.92
(-1.51 to -0.33)
-0.52
(-1.09 to 0.05)
Day 57: Fatigue Score Number Analyzed 87 participants 93 participants
-1.09
(-1.70 to -0.48)
-1.22
(-1.81 to -0.63)
Day 57: Pain Score Number Analyzed 87 participants 93 participants
-0.60
(-1.24 to 0.05)
-0.90
(-1.52 to -0.27)
Day 85: Dryness Score Number Analyzed 85 participants 90 participants
-0.68
(-1.25 to -0.11)
-0.91
(-1.46 to -0.36)
Day 85: Fatigue Score Number Analyzed 85 participants 90 participants
-1.27
(-1.91 to -0.63)
-1.56
(-2.18 to -0.94)
Day 85: Pain Score Number Analyzed 85 participants 90 participants
-0.70
(-1.35 to -0.05)
-1.31
(-1.93 to -0.68)
Day 113: Dryness Score Number Analyzed 83 participants 88 participants
-0.74
(-1.36 to -0.12)
-1.19
(-1.79 to -0.60)
Day 113: Fatigue Score Number Analyzed 83 participants 88 participants
-1.02
(-1.65 to -0.39)
-1.76
(-2.37 to -1.15)
Day 113: Pain Score Number Analyzed 83 participants 88 participants
-0.76
(-1.40 to -0.11)
-1.37
(-1.99 to -0.74)
Day 141: Dryness Score Number Analyzed 82 participants 89 participants
-0.89
(-1.49 to -0.28)
-1.05
(-1.63 to -0.46)
Day 141: Fatigue Score Number Analyzed 82 participants 89 participants
-1.18
(-1.83 to -0.53)
-1.73
(-2.36 to -1.11)
Day 141: Pain Score Number Analyzed 82 participants 89 participants
-0.70
(-1.34 to -0.07)
-1.39
(-2.00 to -0.78)
Day 169: Dryness Score Number Analyzed 81 participants 88 participants
-0.84
(-1.46 to -0.23)
-1.04
(-1.63 to -0.44)
Day 169: Fatigue Score Number Analyzed 81 participants 88 participants
-1.28
(-1.93 to -0.64)
-1.57
(-2.19 to -0.95)
Day 169: Pain Score Number Analyzed 81 participants 88 participants
-1.11
(-1.75 to -0.47)
-1.45
(-2.06 to -0.83)
23.Secondary Outcome
Title Change From Baseline in Schirmer's Test
Hide Description

The Mean change from baseline in Schirmer's Test at all measured time points up to day 169

The length in millimeters that the strip wets during the 5 minute test period for each eye. Collection is done separately for each eye.

Time Frame Day 85, Day 169
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Modified ITT Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (95% Confidence Interval)
Unit of Measure: millimeters
Day 85: Study Eye Number Analyzed 81 participants 85 participants
1.9
(-0.0 to 3.9)
1.5
(-0.5 to 3.5)
Day 85: Non-Study Eye Number Analyzed 81 participants 84 participants
0.1
(-2.0 to 2.2)
0.8
(-1.2 to 2.9)
Day 85: Average of Both Eyes Number Analyzed 81 participants 84 participants
1.10
(-0.75 to 2.96)
1.41
(-0.43 to 3.24)
Day 169: Study Eye Number Analyzed 73 participants 75 participants
1.7
(-0.4 to 3.9)
1.0
(-1.1 to 3.2)
Day 169: Non-Study Eye Number Analyzed 73 participants 74 participants
0.6
(-1.3 to 2.4)
0.2
(-1.7 to 2.1)
Day 169: Average of Both Eyes Number Analyzed 73 participants 74 participants
1.21
(-0.59 to 3.00)
0.82
(-0.97 to 2.61)
24.Secondary Outcome
Title Change From Baseline in the Ocular Staining Score (OSS)
Hide Description

The Mean change from baseline in OSS at all measured time points up to day 169

Score of 0 = No Staining Score of 12 = diffuse staining

The total score will be calculated as the sum of the score for these parameters for each eye.

Medial Nasal Bulbar Conjunctiva (MNBC) [score scale: 0 - 3], Corneal (CORN) Staining of Punctate Epithelial Erosions (PEE) [score scale: 0 - 3], Lateral Temporal Bulbar Conjunctiva (LTBC) [score scale: 0 - 3], Patches of Confluent Staining (CONF) [score scale: 0 - 1], PEE observed in the pupil region, i.e. central 4mm diameter portion of the cornea (PUPL) [score scale: 0 - 1], one of more filaments seen anywhere on the cornea (FILA) [score scale: 0 - 1]

Time Frame Day 85, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
Day 85: Study Eye Number Analyzed 81 participants 86 participants
-1.7
(-2.5 to -0.9)
-0.5
(-1.3 to 0.3)
Day 85: Non-Study Eye Number Analyzed 81 participants 85 participants
-0.6
(-1.4 to 0.2)
0.4
(-0.4 to 1.2)
Day 85: Average of Both Eyes Number Analyzed 81 participants 85 participants
-1.15
(-1.91 to -0.39)
-0.06
(-0.81 to 0.68)
Day 169: Study Eye Number Analyzed 73 participants 75 participants
-1.5
(-2.3 to -0.6)
-0.7
(-1.6 to 0.1)
Day 169: Non-Study Eye Number Analyzed 73 participants 74 participants
-0.5
(-1.3 to 0.3)
0.3
(-0.5 to 1.2)
Day 169: Average of Both Eyes Number Analyzed 73 participants 74 participants
-0.99
(-1.79 to -0.19)
-0.19
(-0.98 to 0.60)
25.Secondary Outcome
Title Change From Baseline in Tear Break-up Time
Hide Description

The Mean change from baseline in Tear Break-up Time at all measured time points up to day 169

The CRF collects the time in seconds to first appearance of a random dry spot on the corneal surface for 3 repetitions in each eye. The average time will calculated for each eye averaging the 3 measurements for each eye separately. In case only 2 measurements are available, the average of the 2 measurements will be calculated. In case there is only 1 measurement, that measurement will be used for the analysis.

Time Frame Day 85, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (95% Confidence Interval)
Unit of Measure: Seconds
Day 85: Study Eye Number Analyzed 81 participants 86 participants
-0.13
(-0.99 to 0.73)
0.18
(-0.67 to 1.04)
Day 85: Non-Study Eye Number Analyzed 81 participants 86 participants
-0.70
(-1.59 to 0.18)
-0.12
(-1.01 to 0.76)
Day 85: Average of Both Eyes Number Analyzed 81 participants 86 participants
-0.41
(-1.24 to 0.43)
0.09
(-0.74 to 0.92)
Day 169: Study Eye Number Analyzed 73 participants 75 participants
-0.23
(-1.11 to 0.64)
-0.32
(-1.19 to 0.56)
Day 169: Non-Study Eye Number Analyzed 73 participants 74 participants
-0.79
(-1.62 to 0.03)
-0.62
(-1.46 to 0.21)
Day 169: Average of Both Eyes Number Analyzed 73 participants 74 participants
-0.50
(-1.32 to 0.31)
-0.43
(-1.25 to 0.39)
26.Secondary Outcome
Title Change From Baseline in Unstimulated Salivary Flow
Hide Description The mean change from baseline in unstimulated whole salivary flow at all measured time points up to Day 169.
Time Frame Day 85, Day 169
Hide Outcome Measure Data
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Modified ITT Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (95% Confidence Interval)
Unit of Measure: mL/min
Day 85 Number Analyzed 86 participants 93 participants
0.106
(-0.037 to 0.249)
0.158
(0.022 to 0295)
Day 169 Number Analyzed 81 participants 87 participants
0.051
(-0.100 to 0.203)
0.105
(-0.042 to 0.251)
27.Secondary Outcome
Title Change From Baseline in Stimulated Salivary Flow
Hide Description The mean change from baseline in Stimulated whole salivary flow at all measured time points up to Day 169.
Time Frame Day 85, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 88 88
Mean (95% Confidence Interval)
Unit of Measure: mL/min
Day 85 Number Analyzed 82 participants 87 participants
0.11
(-0.039 to 0.262)
0.169
(0.024 to 0.314)
Day 169 Number Analyzed 77 participants 81 participants
0.056
(-0.104 to 0.216)
0.108
(-0.048 to 0.263)
28.Secondary Outcome
Title Change From Baseline in Numeric Rating Scale for Mouth Dryness
Hide Description

The mean change from baseline in participant symptoms using the Numeric Rating Scale (NRS) for mouth dryness at all measured time points up to Day 169.

The oral and ocular dryness are each assessed by the patients with numeric rating scales from 0 to 10 with 0 representing no dryness and 10 representing maximal dryness

Time Frame Day 1, 29, 57, 85, 113, 141, 169
Hide Outcome Measure Data
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Modified ITT Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (Full Range)
Unit of Measure: Score on a Scale
Day 29 Number Analyzed 89 participants 92 participants
-0.8
(-8 to 3)
-0.5
(-7 to 6)
Day 57 Number Analyzed 87 participants 92 participants
-1.3
(-8 to 5)
-0.9
(-7 to 6)
Day 85 Number Analyzed 85 participants 90 participants
-1.3
(-9 to 4)
-1.1
(-6 to 8)
Day 113 Number Analyzed 83 participants 88 participants
-1.2
(-9 to 3)
-1.3
(-8 to 4)
Day 141 Number Analyzed 82 participants 90 participants
-1.3
(-8 to 5)
-1.1
(-6 to 6)
Day 169 Number Analyzed 81 participants 88 participants
-1.3
(-8 to 3)
-1.2
(-6 to 8)
29.Secondary Outcome
Title Change From Baseline in Numeric Rating Scale for Eye Dryness
Hide Description

The mean change from baseline in patient symptoms using the Numeric Rating Scale (NRS) for eye dryness at all measured time points up to Day 169.

The oral and ocular dryness are each assessed by the patients with numeric rating scales from 0 to 10 with 0 representing no dryness and 10 representing maximal dryness

Time Frame Day 1, 29, 57, 85, 113, 141, 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (Full Range)
Unit of Measure: Score on a Scale
Day 29 Number Analyzed 89 participants 92 participants
-0.4
(-8 to 5)
-0.3
(-6 to 5)
Day 57 Number Analyzed 87 participants 92 participants
-0.9
(-7 to 5)
-0.6
(-6 to 5)
Day 85 Number Analyzed 85 participants 90 participants
-0.9
(-7 to 6)
-0.8
(-7 to 8)
Day 113 Number Analyzed 83 participants 88 participants
-1.0
(-7 to 7)
-1.1
(-8 to 4)
Day 141 Number Analyzed 82 participants 90 participants
-0.8
(-7 to 7)
-1.0
(-7 to 4)
Day 169 Number Analyzed 81 participants 88 participants
-0.9
(-5 to 6)
-1.0
(-7 to 5)
30.Secondary Outcome
Title Change From Baseline in Participant Assessment of Disease Activity
Hide Description

The participant global assessment of disease activity are assessed with visual analog scales. The participant marks a vertical line through a horizontal line, where the beginning of the horizontal line represents the best situation, and the end of the horizontal line represents the very worst situation. The CRF collects the distance in millimeters from the start of the scale that is marked as well as the length of the scale in millimeters.

In cases that the length of the scale is in less or more than 100 millimeters, then the participants measurement will be rescaled to the equivalent of 100 millimeters using the formula below:

Rescale Measurement in mm = (measurement as reported on CRF in mm/length of the line on CRF in mm) * 100mm

A negative score = participant assessment of disease activity has improved

A positive score = participant assessment of disease activity has worsened

Time Frame Day 29, 57, 85, 113, 141, 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (95% Confidence Interval)
Unit of Measure: Score on VAS 0-100mm scale
Day 29 Number Analyzed 89 participants 92 participants
-4.0
(-9.8 to 1.7)
-7.1
(-12.7 to -1.4)
Day 57 Number Analyzed 86 participants 93 participants
-7.5
(-13.4 to -1.7)
-6.3
(-11.9 to -0.6)
Day 85 Number Analyzed 85 participants 89 participants
-10.4
(-16.3 to -4.4)
-10.2
(-16.0 to -4.4)
Day 113 Number Analyzed 83 participants 88 participants
-8.0
(-14.0 to -2.0)
-9.7
(-15.5 to -3.9)
Day 141 Number Analyzed 82 participants 90 participants
-5.1
(-11.0 to 0.8)
-11.0
(-16.7 to -5.3)
Day 169 Number Analyzed 81 participants 88 participants
-10.1
(-16.1 to -4.0)
-9.0
(-14.8 to -3.1)
31.Secondary Outcome
Title Change From Baseline in Physician Global Assessment of Disease Activity
Hide Description

The physician global assessment of disease activity are assessed with visual analog scales. The physician marks a vertical line through a horizontal line, where the beginning of the horizontal line represents the best situation, and the end of the horizontal line represents the very worst situation. The CRF collects the distance in millimeters from the start of the scale that is marked as well as the length of the scale in millimeters.

In cases that the length of the scale is in less or more than 100 millimeters, then the participants measurement will be rescaled to the equivalent of 100 millimeters using the formula below:

Rescale Measurement in mm = (measurement as reported on CRF in mm/length of the line on CRF in mm) * 100mm

A negative score = physician assessment of disease activity has improved

A positive score = physician assessment of disease activity has worsened

Time Frame Day 29, 57, 85, 113, 141, 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (95% Confidence Interval)
Unit of Measure: Score on VAS 0-100mm Scale
Day 29 Number Analyzed 89 participants 89 participants
-10.3
(-14.8 to -5.8)
-10.5
(-14.9 to -6.1)
Day 57 Number Analyzed 86 participants 92 participants
-16.2
(-20.8 to -11.7)
-16.7
(-21.1 to -12.3)
Day 85 Number Analyzed 85 participants 89 participants
-20.8
(-25.6 to -16.0)
-19.4
(-24.0 to -14.7)
Day 113 Number Analyzed 82 participants 87 participants
-22.8
(-27.9 to -17.8)
-19.8
(-24.6 to -14.9)
Day 141 Number Analyzed 82 participants 89 participants
-23.7
(-28.6 to -18.8)
-21.7
(-26.5 to -17.0)
Day 169 Number Analyzed 81 participants 87 participants
-23.0
(-27.8 to -18.2)
-23.7
(-28.3 to -19.0)
32.Secondary Outcome
Title Change From Baseline in Patient Fatigue
Hide Description

The mean change from baseline in patient fatigue using Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue assessment of disease activity at all measured time points up to Day 169.

PROMIS Fatigue instruments 10 Questions ranging from a score 0 to 40. Sum of the values gives you the raw sum. The raw is inputted into this formula to give you the raw score:

Raw Score = (Raw sum*number of items on the short form)/(Number of items that were actually answered)

Raw score is translated to a T-Score using a table. T-Score is used as the final score.

The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. The standardized T-score is reported as the final score for each participant.

A negative T Score = Better Prognosis A positive T Score = Worse prognosis

Time Frame Day 29, 57, 85, 113, 141, 169
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (95% Confidence Interval)
Unit of Measure: T-Score
Day 29 Number Analyzed 90 participants 92 participants
-3.08
(-5.22 to -0.95)
-3.99
(-6.09 to -1.88)
Day 57 Number Analyzed 87 participants 92 participants
-4.12
(-6.27 to -1.97)
-4.02
(-6.12 to -1.91)
Day 85 Number Analyzed 85 participants 90 participants
-4.85
(-7.05 to -2.64)
-5.48
(-7.64 to -3.32)
Day 113 Number Analyzed 83 participants 87 participants
-4.17
(-6.37 to -1.97)
-5.32
(-7.48 to -3.17)
Day 141 Number Analyzed 82 participants 89 participants
-4.84
(-7.06 to -2.62)
-5.68
(-7.85 to -3.52)
Day 169 Number Analyzed 81 participants 87 participants
-5.56
(-7.83 to -3.28)
-5.59
(-7.82 to -3.37)
33.Secondary Outcome
Title Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI)
Hide Description

For the FSFI, is a 19 item instrument used for assessing key dimensions of female sexual function over the past 4 weeks with 6 domains being analyzed. The specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI are scored on a scale ranging from 0 to 5, with higher scores indicating better performance. Domain scores are calculated by summing the scores of the individual questions that make up the domain and multiplying the sum by the factor in the table below. The full scale score is the sum of the six domain scores.

Full Scale Score range: 2.0(minimum score) - 36.0 (maximum score)

Negative Score = Reduced functioning Positive Score = Improved functioning

Time Frame Day 85, Day 169
Hide Outcome Measure Data
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Modified ITT Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 88 88
Mean (95% Confidence Interval)
Unit of Measure: Scores on a Scale
Day 85 Number Analyzed 62 participants 58 participants
-2.44
(-5.67 to 0.78)
-1.56
(-4.90 to 1.77)
Day 169 Number Analyzed 60 participants 50 participants
-2.32
(-5.73 to 1.09)
-1.87
(-5.42 to 1.68)
34.Secondary Outcome
Title Change From Baseline in 36-item Short Form Health Survey (SF-36)
Hide Description

The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.

Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement

Time Frame Day 85, Day 169
Hide Outcome Measure Data
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Modified ITT Population
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
Day 85: Physical Function Number Analyzed 89 participants 92 participants
1.908
(-0.240 to 4.056)
1.523
(-0.568 to 3.614)
Day 85: Role Physical Number Analyzed 90 participants 92 participants
5.248
(3.112 to 7.383)
4.416
(2.321 to 6.511)
Day 85: Bodily Pain Number Analyzed 90 participants 92 participants
3.200
(0.910 to 5.490)
3.721
(1.464 to 5.978)
Day 85: General Health Number Analyzed 90 participants 92 participants
4.042
(1.938 to 6.146)
3.409
(1.363 to 5.456)
Day 85: Vitality Number Analyzed 90 participants 92 participants
3.827
(1.269 to 6.384)
3.859
(1.335 to 6.382)
Day 85: Social Functioning Number Analyzed 90 participants 92 participants
3.020
(0.296 to 5.744)
4.771
(2.117 to 7.426)
Day 85: Role-Emotional Number Analyzed 90 participants 92 participants
3.024
(0.214 to 5.834)
4.834
(2.093 to 7.576)
Day 85: Mental Health Number Analyzed 90 participants 92 participants
2.942
(0.458 to 5.425)
2.287
(-0.135 to 4.709)
Day 85: Physical component Summary Number Analyzed 89 participants 92 participants
3.430
(1.615 to 5.244)
2.686
(0.904 to 4.468)
Day 85: Mental component Summary Number Analyzed 89 participants 92 participants
2.693
(0.160 to 5.226)
3.672
(1.208 to 6.136)
Day 169: Physical Function Number Analyzed 82 participants 91 participants
2.927
(0.593 to 5.261)
1.742
(-0.505 to 3.989)
Day 169: Role-Physical Number Analyzed 83 participants 91 participants
5.853
(3.756 to 7.949)
4.626
(2.604 to 6.649)
Day 169: Bodily Pain Number Analyzed 83 participants 91 participants
3.842
(1.432 to 6.252)
3.458
(1.114 to 5.801)
Day 169: General Health Number Analyzed 83 participants 91 participants
3.880
(1.700 to 6.060)
3.764
(1.665 to 5.862)
Day 169: Vitality Number Analyzed 82 participants 91 participants
3.742
(1.160 to 6.324)
4.523
(2.005 to 7.041)
Day 169: Social functioning Number Analyzed 83 participants 91 participants
4.125
(1.320 to 6.929)
4.471
(1.773 to 7.169)
Day 169: Role-Emotional Number Analyzed 83 participants 91 participants
4.653
(1.943 to 7.364)
4.930
(2.334 to 7.526)
Day 169: Mental Health Number Analyzed 83 participants 91 participants
2.375
(-0.116 to 4.866)
2.972
(0.581 to 5.363)
Day 169: Physical Component Summary Number Analyzed 81 participants 91 participants
3.998
(2.045 to 5.951)
2.650
(0.756 to 4.543)
Day 169: Mental Component Summary Number Analyzed 81 participants 91 participants
2.940
(0.368 to 5.512)
4.112
(1.648 to 6.577)
35.Secondary Outcome
Title Geometric Mean of Trough Concentration (Cmin) of Abatacept
Hide Description Geometric mean of trough concentration (Cmin) of abatacept at all measured time points.
Time Frame Day 29, 85, 113, 141, 169
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Pharmacokinetic (PK) Evaluable Population
Arm/Group Title Abatacept Placebo
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SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
Day 29 Number Analyzed 68 participants 0 participants
21.401
(36%)
Day 85 Number Analyzed 72 participants 0 participants
27.543
(38.4%)
Day 113 Number Analyzed 72 participants 0 participants
25.567
(42.1%)
Day 141 Number Analyzed 74 participants 0 participants
25.870
(40.8%)
Day 169 Number Analyzed 74 participants 0 participants
24.522
(42.7%)
36.Secondary Outcome
Title Percentage of Participants With a Positive Antibody Response
Hide Description Percentage of participants with at least one positive immunogenicity response up to Day 169 and during 3 months follow up (for participants who discontinue during the 6-months double-blind).
Time Frame Day 85 db, day 169 db, post treatment day 85
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Immunogenicity Analysis Population
Arm/Group Title Abatacept Placebo
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SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 90 43
Measure Type: Number
Unit of Measure: Percentage
Study Day 169 Number Analyzed 81 participants 0 participants
1.2
Post Treatment Day 85 (DB) Number Analyzed 5 participants 0 participants
0
Post Treatment Day 169 (DB) Number Analyzed 4 participants 0 participants
0
37.Secondary Outcome
Title Summary of Adverse Events: Double Blind Period
Hide Description Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation
Time Frame Day 1 up to first dose of Open Label Treatment Period (OLTP) abatacept or up to 56 post last dose in double -blind for those not in OL.
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As-Treated Population
Arm/Group Title Abatacept Placebo
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SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 92 95
Measure Type: Number
Unit of Measure: Percentage
Adverse Events (AEs) 85.9 71.6
Deaths 0 1.1
Serious Adverse Events 9.8 3.2
Discontinuation due to AEs 3.3 2.1
38.Secondary Outcome
Title Laboratory Marked Abnormalities: Double Blind Period
Hide Description Laboratory values meeting the marked abnormality criteria
Time Frame Day 1 up to first dose of OL abatacept or up to 56 post last dose in double -blind for those not in OL.
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Hide Analysis Population Description
As-Treated Analysis Population
Arm/Group Title Abatacept Placebo
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SC injection 125mg/mL in 1 mL pre-filled syringe
SC injection in 1 mL pre-filled syringe
Overall Number of Participants Analyzed 91 95
Measure Type: Number
Unit of Measure: Percentage
Hematocrit High NA [1]  NA [1] 
Hematocrit Low 0 0
Hemoglobin High NA [1]  NA [1] 
Hemoglobin Low 0 0
Platelet count High 0 0
Platelet count low 0 0
Leukocytes high 1.1 0
Leukocytes low 12.1 8.4
Basophils high 0 0
Basophils Low NA [1]  NA [1] 
Eosinophils High 4.4 1.1
Eosinophils Low NA [1]  NA [1] 
lymphocytes high 0 0
lymphocytes low 9.9 14.7
Monocytes high 0 0
Monocytes Low NA [1]  NA [1] 
Neutrophils+Bands High NA [1]  NA [1] 
Neutrophils+Bands Low 6.6 1.1
Alanine Aminotransferase High 1.1 2.1
Alkaline Phosphatase HIgh 0 0
Aspartate Aminotransferase High 1.1 3.2
Bilirubin, Total High 0 0
G-Glutamyl Transferase High 6.6 1.1
Blood Urea Nitrogen High 1.1 1.1
Creatinine High 0 0
Calcium High 0 0
Calcium Low 1.1 0
Chloride High 0 0
Chloride Low 1.1 0
Phosphorus High 0 0
Phosphorus Low 0 1.1
Potassium High 0 0
Potassium Low 1.1 0
Sodium High 0 1.1
Sodium Low 2.2 0
Glucose, Serum High 0 1.1
Glucose, Serum Low 2.2 5.3
Albumin High NA [1]  NA [1] 
Albumin Low 2.2 1.1
Protein, Total High 2.2 3.2
Protein, Total Low 1.1 0
Creatine Kinase High 0 4.2
Blood, Urine High 14.3 9.5
Blood, Urine Low NA [1]  NA [1] 
Glucose, Urine High 0 0
Glucose, Urine Low NA [1]  NA [1] 
Protein, Urine High 2.2 3.2
[1]
Not Evaluated
Time Frame First dose to 56 days past double blind period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description SC Injection 125mg/mL in 1 mL pre-filled syringe SC injection in 1 mL pre-filled syringe
All-Cause Mortality
Abatacept Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/92 (0.00%)   1/95 (1.05%) 
Hide Serious Adverse Events
Abatacept Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   9/92 (9.78%)   3/95 (3.16%) 
Cardiac disorders     
Acute myocardial infarction  1  0/92 (0.00%)  1/95 (1.05%) 
Prinzmetal angina  1  1/92 (1.09%)  0/95 (0.00%) 
Gastrointestinal disorders     
Colitis  1  0/92 (0.00%)  1/95 (1.05%) 
Intestinal obstruction  1  1/92 (1.09%)  0/95 (0.00%) 
Hepatobiliary disorders     
Hepatic cyst ruptured  1  1/92 (1.09%)  0/95 (0.00%) 
Immune system disorders     
Anaphylactoid reaction  1  1/92 (1.09%)  0/95 (0.00%) 
Drug hypersensitivity  1  1/92 (1.09%)  0/95 (0.00%) 
Infections and infestations     
Pneumonia bacterial  1  1/92 (1.09%)  0/95 (0.00%) 
Septic shock  1  0/92 (0.00%)  1/95 (1.05%) 
Musculoskeletal and connective tissue disorders     
Arthropathy  1  1/92 (1.09%)  0/95 (0.00%) 
Intervertebral disc protrusion  1  1/92 (1.09%)  0/95 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Plasma cell myeloma  1  1/92 (1.09%)  0/95 (0.00%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abatacept Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   47/92 (51.09%)   40/95 (42.11%) 
Gastrointestinal disorders     
Abdominal pain upper  1  5/92 (5.43%)  0/95 (0.00%) 
Diarrhoea  1  11/92 (11.96%)  4/95 (4.21%) 
Nausea  1  9/92 (9.78%)  4/95 (4.21%) 
Infections and infestations     
Nasopharyngitis  1  11/92 (11.96%)  18/95 (18.95%) 
Upper respiratory tract infection  1  9/92 (9.78%)  7/95 (7.37%) 
Urinary tract infection  1  6/92 (6.52%)  8/95 (8.42%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  6/92 (6.52%)  2/95 (2.11%) 
Nervous system disorders     
Headache  1  10/92 (10.87%)  9/95 (9.47%) 
Psychiatric disorders     
Insomnia  1  5/92 (5.43%)  1/95 (1.05%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  5/92 (5.43%)  4/95 (4.21%) 
Oropharyngeal pain  1  6/92 (6.52%)  1/95 (1.05%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
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Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: Please Email
EMail: Clinical.Trials@bms.com
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02915159    
Other Study ID Numbers: IM101-603
2016-001948-19 ( EudraCT Number )
First Submitted: September 23, 2016
First Posted: September 26, 2016
Results First Submitted: August 7, 2019
Results First Posted: January 2, 2020
Last Update Posted: March 19, 2020