Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome (NCT NCT02915159)

Last Updated: 2020-08-10

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

250 participants

Primary outcome timeframe

Day 169

Results posted on

2020-08-10

Participant Flow

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

Participant milestones

Participant milestones
Measure	Abatacept - Double Blind Treatment Period Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Overall Study STARTED	92	95
Overall Study COMPLETED	81	87
Overall Study NOT COMPLETED	11	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Abatacept - Double Blind Treatment Period Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Overall Study Participant no longer meets criteria	2	0
Overall Study poor/non-compliance	1	0
Overall Study Participant withdrew consent	5	1
Overall Study Request to discontinue treatment	1	2
Overall Study Adverse Event	2	2
Overall Study Lack of Efficacy	0	3

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe	Total n=187 Participants Total of all reporting groups
Age, Continuous	51.2 Years STANDARD_DEVIATION 12.3 • n=5 Participants	52.9 Years STANDARD_DEVIATION 13.5 • n=7 Participants	52.0 Years STANDARD_DEVIATION 12.9 • n=5 Participants
Age, Customized < 65 years	80 Participants n=5 Participants • 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.	73 Participants n=7 Participants • 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.	153 Participants n=5 Participants • 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.
Age, Customized ≥ 65 years	12 Participants n=5 Participants • 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.	22 Participants n=7 Participants • 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.	34 Participants n=5 Participants • 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.
Age, Customized ≤ 50 years	42 Participants n=5 Participants • 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.	42 Participants n=7 Participants • 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.	84 Participants n=5 Participants • 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.
Age, Customized > 50 years	50 Participants n=5 Participants • 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.	53 Participants n=7 Participants • 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.	103 Participants n=5 Participants • 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 Female	85 Participants n=5 Participants	92 Participants n=7 Participants	177 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	80 Participants n=5 Participants	77 Participants n=7 Participants	157 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	60 Participants n=5 Participants	60 Participants n=7 Participants	120 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 169

Population: Modified Intent-to-treat (ITT) analysis population: all randomized participants who receive at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)	-3.2 Score on a Scale Interval -4.6 to -1.9	-3.7 Score on a Scale Interval -5.0 to -2.4

SECONDARY outcome

Timeframe: Day 169

Population: Modified ITT Population

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.

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI)	-1.26 Score on a Scale Interval -1.88 to -0.64	-1.52 Score on a Scale Interval -2.12 to -0.93

SECONDARY outcome

Timeframe: Day 169

Population: Modified ITT Population with Stimulated Whole Salivary Flow of at Least 0.1 mL/min at Both Screening and Baseline

The mean change from baseline in the stimulated whole salivary flow at Day 169

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=88 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=88 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in the Stimulated Whole Salivary Flow	0.057 mL/min Interval -0.115 to 0.23	0.108 mL/min Interval -0.06 to 0.276

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Population: Modified ITT Population

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

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population Day 141	-0.8 Scores on a scale Interval -1.0 to -0.5	-1.0 Scores on a scale Interval -1.3 to -0.8
Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population Day 169	-0.9 Scores on a scale Interval -1.1 to -0.6	-1.1 Scores on a scale Interval -1.4 to -0.9
Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population Day 29	-0.4 Scores on a scale Interval -0.6 to -0.2	-0.4 Scores on a scale Interval -0.6 to -0.2
Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population Day 57	-0.6 Scores on a scale Interval -0.8 to -0.4	-0.7 Scores on a scale Interval -0.9 to -0.4
Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population Day 85	-0.8 Scores on a scale Interval -1.0 to -0.6	-0.8 Scores on a scale Interval -1.1 to -0.6
Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population Day 113	-0.8 Scores on a scale Interval -1.0 to -0.5	-1.0 Scores on a scale Interval -1.2 to -0.7

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Population: Modified ITT Population with Baseline Tender plus Swollen Joint Count of at Least 3

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=57 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=63 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 Day 113	-1.1 Scores on a scale Interval -1.4 to -0.7	-1.4 Scores on a scale Interval -1.7 to -1.0
Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 Day 29	-0.5 Scores on a scale Interval -0.8 to -0.2	-0.6 Scores on a scale Interval -0.9 to -0.3
Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 Day 57	-0.9 Scores on a scale Interval -1.2 to -0.5	-1.0 Scores on a scale Interval -1.3 to -0.6
Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 Day 85	-1.1 Scores on a scale Interval -1.5 to -0.7	-1.2 Scores on a scale Interval -1.5 to -0.8
Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 Day 141	-1.2 Scores on a scale Interval -1.5 to -0.8	-1.5 Scores on a scale Interval -1.8 to -1.1
Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 Day 169	-1.3 Scores on a scale Interval -1.7 to -0.9	-1.5 Scores on a scale Interval -1.9 to -1.2

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Population: Modified ITT Population with Baseline Tender plus Swollen Joint Count of Less than 3

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=35 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=31 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 Day 57	-0.2 Scores on a scale Interval -0.5 to 0.1	-0.2 Scores on a scale Interval -0.5 to 0.1
Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 Day 85	-0.4 Scores on a scale Interval -0.6 to -0.1	-0.4 Scores on a scale Interval -0.7 to -0.1
Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 Day 113	-0.3 Scores on a scale Interval -0.6 to 0.0	-0.3 Scores on a scale Interval -0.6 to -0.1
Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 Day 141	-0.2 Scores on a scale Interval -0.5 to 0.1	-0.4 Scores on a scale Interval -0.7 to 0.0
Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 Day 169	-0.3 Scores on a scale Interval -0.5 to 0.0	-0.5 Scores on a scale Interval -0.7 to -0.2
Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 Day 29	-0.3 Scores on a scale Interval -0.6 to 0.0	-0.2 Scores on a scale Interval -0.6 to 0.1

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Population: Modified intent to treat (ITT)

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

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population Day 29 - Tender Joint	-1.7 Joint Count Interval -2.8 to -0.7	-1.9 Joint Count Interval -2.9 to -0.8
Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population Day 29 - Swollen Joint	-0.5 Joint Count Interval -1.0 to 0.1	-0.6 Joint Count Interval -1.1 to -0.1
Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population Day 57 - Tender Joint	-2.6 Joint Count Interval -3.7 to -1.5	-2.9 Joint Count Interval -4.0 to -1.9
Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population Day 57 - Swollen Joint	-1.0 Joint Count Interval -1.6 to -0.3	-1.0 Joint Count Interval -1.6 to -0.4
Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population Day 85 - Tender Joint	-2.9 Joint Count Interval -4.1 to -1.7	-3.4 Joint Count Interval -4.6 to -2.2
Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population Day 85 - Swollen Joint	-1.4 Joint Count Interval -2.0 to -0.8	-1.4 Joint Count Interval -2.0 to -0.9
Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population Day 113 - Tender Joint	-3.1 Joint Count Interval -4.2 to -2.0	-3.9 Joint Count Interval -5.0 to -2.8
Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population Day 113 - Swollen Joint	-1.5 Joint Count Interval -2.0 to -1.1	-1.9 Joint Count Interval -2.3 to -1.4
Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population Day 141 - Tender Joint	-3.6 Joint Count Interval -4.7 to -2.5	-4.1 Joint Count Interval -5.2 to -3.0
Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population Day 141 - Swollen Joint	-1.4 Joint Count Interval -1.9 to -0.8	-1.8 Joint Count Interval -2.4 to -1.3
Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population Day 169 - Tender Joint	-2.9 Joint Count Interval -4.0 to -1.7	-4.4 Joint Count Interval -5.6 to -3.3
Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population Day 169 - Swollen Joint	-1.4 Joint Count Interval -1.9 to -0.8	-2.0 Joint Count Interval -2.6 to -1.5

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Population: Modified intent to treat (ITT)

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

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population Day 141 - CRP	3.5 mg/L Interval -1.7 to 8.8	-0.2 mg/L Interval -5.2 to 4.7
Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population Day 169 - CRP	-0.2 mg/L Interval -1.8 to 1.3	0.0 mg/L Interval -1.5 to 1.5
Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population Day 85 - CRP	-0.2 mg/L Interval -5.0 to 4.5	3.0 mg/L Interval -1.6 to 7.6
Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population Day 113 - CRP	1.6 mg/L Interval -0.8 to 4.1	0.3 mg/L Interval -2.1 to 2.6
Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population Day 29 - CRP	0.3 mg/L Interval -1.4 to 2.0	0.6 mg/L Interval -1.0 to 2.3
Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population Day 57 - CRP	-0.1 mg/L Interval -2.1 to 1.8	1.8 mg/L Interval -0.1 to 3.6

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Population: Modified intent to treat (ITT)

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

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population Day 29 - Assessment of Disease Activity	-4.0 Scores on a Scale Interval -9.8 to 1.7	-7.1 Scores on a Scale Interval -12.7 to -1.4
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population Day 57 - Assessment of Disease Activity	-7.5 Scores on a Scale Interval -13.4 to -1.7	-6.3 Scores on a Scale Interval -11.9 to -0.6
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population Day 85 - Assessment of Disease Activity	-10.4 Scores on a Scale Interval -16.3 to -4.4	-10.2 Scores on a Scale Interval -16.0 to -4.4
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population Day 113 - Assessment of Disease Activity	-8.0 Scores on a Scale Interval -14.0 to -2.0	-9.7 Scores on a Scale Interval -15.5 to -3.9
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population Day 141 - Assessment of Disease Activity	-5.1 Scores on a Scale Interval -11.0 to 0.8	-11.0 Scores on a Scale Interval -16.7 to -5.3
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population Day 169 - Assessment of Disease Activity	-10.1 Scores on a Scale Interval -16.1 to -4.0	-9.0 Scores on a Scale Interval -14.8 to -3.1

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Population: Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of at least 3

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=57 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=63 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 29 - Tender Joint	-2.8 Joint Count Interval -4.5 to -1.0	-3.0 Joint Count Interval -4.7 to -1.3
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 29 - Swollen Joint	-0.7 Joint Count Interval -1.5 to 0.2	-0.9 Joint Count Interval -1.7 to -0.1
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 57 - Tender Joint	-4.1 Joint Count Interval -5.9 to -2.3	-4.8 Joint Count Interval -6.5 to -3.0
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 57 - Swollen Joint	-1.5 Joint Count Interval -2.6 to -0.5	-1.6 Joint Count Interval -2.6 to -0.5
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 85 - Tender Joint	-4.4 Joint Count Interval -6.3 to -2.4	-5.4 Joint Count Interval -7.2 to -3.6
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 85 - Swollen Joint	-2.1 Joint Count Interval -3.1 to -1.1	-2.2 Joint Count Interval -3.2 to -1.3
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 113 - Tender Joint	-4.8 Joint Count Interval -6.6 to -2.9	-6.0 Joint Count Interval -7.7 to -4.2
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 113 - Swollen Joint	-2.3 Joint Count Interval -3.2 to -1.5	-2.9 Joint Count Interval -3.7 to -2.2
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 141 - Tender Joint	-5.7 Joint Count Interval -7.5 to -3.8	-6.4 Joint Count Interval -8.2 to -4.7
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 141 - Swollen Joint	-2.2 Joint Count Interval -3.1 to -1.3	-3.0 Joint Count Interval -3.8 to -2.1
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 169 - Tender Joint	-4.6 Joint Count Interval -6.5 to -2.7	-6.7 Joint Count Interval -8.5 to -4.9
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 169 - Swollen Joint	-2.2 Joint Count Interval -3.1 to -1.3	-3.1 Joint Count Interval -4.0 to -2.3

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Population: Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of at least 3

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=57 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=63 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 29 - CRP	-1.5 mg/L Interval -3.7 to 0.7	-0.7 mg/L Interval -2.8 to 1.4
Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 57 - CRP	-1.3 mg/L Interval -4.3 to 1.7	1.3 mg/L Interval -1.5 to 4.0
Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 85 - CRP	-2.2 mg/L Interval -9.8 to 5.5	3.8 mg/L Interval -3.4 to 11.0
Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 113 - CRP	1.2 mg/L Interval -2.7 to 5.1	-0.4 mg/L Interval -4.0 to 3.2
Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 141 - CRP	4.5 mg/L Interval -4.0 to 12.9	-1.4 mg/L Interval -9.0 to 6.3
Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 169 - CRP	-1.4 mg/L Interval -3.9 to 1.1	-0.7 mg/L Interval -3.0 to 1.6

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Population: Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of at least 3

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=57 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=63 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 29 - Assessment of Disease Activity	0.6 Score on a Scale Interval -6.9 to 8.1	-3.5 Score on a Scale Interval -10.7 to 3.7
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 57 - Assessment of Disease Activity	-3.5 Score on a Scale Interval -11.5 to 4.5	-6.5 Score on a Scale Interval -14.0 to 1.1
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 85 - Assessment of Disease Activity	-7.5 Score on a Scale Interval -15.5 to 0.4	-7.7 Score on a Scale Interval -15.3 to -0.1
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 113 - Assessment of Disease Activity	-6.6 Score on a Scale Interval -14.4 to 1.3	-9.1 Score on a Scale Interval -16.5 to -1.6
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 141 - Assessment of Disease Activity	-1.2 Score on a Scale Interval -9.0 to 6.7	-8.1 Score on a Scale Interval -15.5 to -0.7
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3 Day 169 - Assessment of Disease Activity	-6.7 Score on a Scale Interval -14.9 to 1.5	-7.8 Score on a Scale Interval -15.5 to 0.0

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Population: Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of Less than 3

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=35 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=31 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 29 - Tender Joint	-0.1 Joint Count Interval -0.9 to 0.6	-0.2 Joint Count Interval -0.9 to 0.6
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 29 - Swollen Joint	0.1 Joint Count Interval -0.2 to 0.3	0.1 Joint Count Interval -0.2 to 0.4
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 57 - Tender Joint	-0.2 Joint Count Interval -0.9 to 0.6	0.1 Joint Count Interval -0.6 to 0.9
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 57 - Swollen Joint	0.2 Joint Count Interval -0.1 to 0.4	0.0 Joint Count Interval -0.2 to 0.3
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 85 - Tender Joint	-0.5 Joint Count Interval -1.3 to 0.2	0.1 Joint Count Interval -0.7 to 0.8
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 85 - Swollen Joint	-0.0 Joint Count Interval -0.3 to 0.2	0.1 Joint Count Interval -0.2 to 0.4
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 113 - Tender Joint	-0.4 Joint Count Interval -1.2 to 0.3	-0.5 Joint Count Interval -1.3 to 0.3
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 113 - Swollen Joint	0.0 Joint Count Interval -0.3 to 0.3	0.1 Joint Count Interval -0.2 to 0.4
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 141 - Tender Joint	-0.2 Joint Count Interval -1.0 to 0.6	-0.2 Joint Count Interval -1.0 to 0.6
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 141 - Swollen Joint	0.2 Joint Count Interval -0.1 to 0.5	0.3 Joint Count Interval 0.0 to 0.6
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 169 - Tender Joint	-0.1 Joint Count Interval -0.9 to 0.7	-0.7 Joint Count Interval -1.4 to 0.1
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 169 - Swollen Joint	0.2 Joint Count Interval -0.1 to 0.5	-0.0 Joint Count Interval -0.3 to 0.2

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Population: Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of Less than 3

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=35 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=31 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 29 - CRP	2.1 mg/L Interval -0.8 to 4.9	1.8 mg/L Interval -1.2 to 4.7
Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 57 - CRP	0.5 mg/L Interval -2.3 to 3.4	1.0 mg/L Interval -1.9 to 3.9
Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 85 - CRP	1.4 mg/L Interval -1.5 to 4.3	0.1 mg/L Interval -2.8 to 3.1
Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 113 - CRP	1.3 mg/L Interval -1.6 to 4.1	0.1 mg/L Interval -2.8 to 3.1
Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 141 - CRP	0.7 mg/L Interval -2.2 to 3.6	0.8 mg/L Interval -2.1 to 3.8
Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 169 - CRP	0.2 mg/L Interval -2.7 to 3.1	0.2 mg/L Interval -2.8 to 3.1

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Population: Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of Less than 3

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=35 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=31 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 57 - Assessment of Disease Activity	-12.4 Scores on a Scale Interval -21.4 to -3.4	-4.8 Scores on a Scale Interval -14.3 to 4.7
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 29 - Assessment of Disease Activity	-10.3 Scores on a Scale Interval -19.3 to -1.4	-11.8 Scores on a Scale Interval -21.3 to -2.3
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 85 - Assessment of Disease Activity	-14.0 Scores on a Scale Interval -23.0 to -5.0	-13.5 Scores on a Scale Interval -23.0 to -4.0
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 113 - Assessment of Disease Activity	-9.1 Scores on a Scale Interval -18.1 to 0.0	-11.1 Scores on a Scale Interval -20.6 to -1.5
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 141 - Assessment of Disease Activity	-10.6 Scores on a Scale Interval -19.8 to -1.5	-15.3 Scores on a Scale Interval -24.8 to -5.7
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 Day 169 - Assessment of Disease Activity	-13.8 Scores on a Scale Interval -23.0 to -4.6	-10.9 Scores on a Scale Interval -20.5 to -1.4

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Population: Modified intent to treat (ITT) Population

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.

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points Day 29	37 Percentage Interval 27.1 to 47.7	34.7 Percentage Interval 25.3 to 45.2
Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points Day 57	37 Percentage Interval 27.1 to 47.7	44.2 Percentage Interval 34.0 to 54.8
Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points Day 85	48.9 Percentage Interval 38.3 to 59.6	50.5 Percentage Interval 40.1 to 60.9
Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points Day 113	55.4 Percentage Interval 44.7 to 65.8	50.5 Percentage Interval 40.1 to 60.9
Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points Day 141	51.1 Percentage Interval 40.4 to 61.7	56.8 Percentage Interval 46.3 to 67.0
Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points Day 169	55.4 Percentage Interval 44.7 to 65.8	57.9 Percentage Interval 47.3 to 68.0

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Population: Modified intent to treat (ITT) Population

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.

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points Day 29	19.6 Percentage Interval 12.0 to 29.1	13.7 Percentage Interval 7.5 to 22.3
Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points Day 57	26.1 Percentage Interval 17.5 to 36.3	24.2 Percentage Interval 16.0 to 34.1
Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points Day 85	34.8 Percentage Interval 25.1 to 45.4	32.6 Percentage Interval 23.4 to 43.0
Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points Day 113	37.0 Percentage Interval 27.1 to 47.7	36.8 Percentage Interval 27.2 to 47.4
Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points Day 141	37.0 Percentage Interval 27.1 to 47.7	36.8 Percentage Interval 31.1 to 51.6
Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points Day 169	35.9 Percentage Interval 26.1 to 46.5	46.3 Percentage Interval 36.0 to 56.8

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Population: Modified intent to treat (ITT) Population

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.

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point Day 169	41.3 Percentage Interval 31.1 to 52.1	52.6 Percentage Interval 42.1 to 63.0
Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point Day 29	31.5 Percentage Interval 22.2 to 42.0	38.9 Percentage Interval 29.1 to 49.5
Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point Day 57	42.4 Percentage Interval 32.1 to 53.1	47.4 Percentage Interval 37.0 to 57.9
Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point Day 85	44.6 Percentage Interval 34.2 to 55.3	55.8 Percentage Interval 45.2 to 66.0
Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point Day 113	42.4 Percentage Interval 32.1 to 53.1	52.6 Percentage Interval 42.1 to 63.0
Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point Day 141	40.2 Percentage Interval 30.1 to 51.0	54.7 Percentage Interval 44.2 to 65.0

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Population: Modified intent to treat (ITT) Population

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline at All Measured Time Points in the ESSDAI Day 29	-10.9 Percent Change from Baseline Interval -22.3 to 0.54	-12.6 Percent Change from Baseline Interval -23.71 to -1.39
Change From Baseline at All Measured Time Points in the ESSDAI Day 141	-29.7 Percent Change from Baseline Interval -43.02 to -16.31	-37.0 Percent Change from Baseline Interval -49.81 to -24.12
Change From Baseline at All Measured Time Points in the ESSDAI Day 169	-33.4 Percent Change from Baseline Interval -46.54 to -20.24	-37.6 Percent Change from Baseline Interval -50.24 to -25.02
Change From Baseline at All Measured Time Points in the ESSDAI Day 57	-24.1 Percent Change from Baseline Interval -36.1 to -12.08	-18.9 Percent Change from Baseline Interval -30.52 to -7.32
Change From Baseline at All Measured Time Points in the ESSDAI Day 85	-26.0 Percent Change from Baseline Interval -38.81 to -13.17	-25.4 Percent Change from Baseline Interval -37.76 to -13.01
Change From Baseline at All Measured Time Points in the ESSDAI Day 113	-34.1 Percent Change from Baseline Interval -46.8 to -21.34	-32.1 Percent Change from Baseline Interval -44.35 to -19.83

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Population: Modified intent to treat (ITT) Population

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline at All Measured Time Points in the ESSPRI Day 85	-0.83 Score on a Scale Interval -1.34 to -0.32	-1.20 Score on a Scale Interval -1.7 to -0.7
Change From Baseline at All Measured Time Points in the ESSPRI Day 169	-1.03 Score on a Scale Interval -1.55 to -0.5	-1.30 Score on a Scale Interval -1.8 to -0.79
Change From Baseline at All Measured Time Points in the ESSPRI Day 29	-0.32 Score on a Scale Interval -0.79 to 0.16	-0.54 Score on a Scale Interval -1.0 to -0.08
Change From Baseline at All Measured Time Points in the ESSPRI Day 57	-0.81 Score on a Scale Interval -1.32 to -0.31	-0.82 Score on a Scale Interval -1.31 to -0.33
Change From Baseline at All Measured Time Points in the ESSPRI Day 113	-0.79 Score on a Scale Interval -1.32 to -0.26	-1.37 Score on a Scale Interval -1.88 to -0.86
Change From Baseline at All Measured Time Points in the ESSPRI Day 141	-0.87 Score on a Scale Interval -1.4 to -0.35	-1.32 Score on a Scale Interval -1.83 to -0.81

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169

Population: Modified ITT Population

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)

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in Components of ESSDAI Day 29: Lymphadenopathy	-0.6 Score on a Scale Interval -1.0 to -0.2	-0.5 Score on a Scale Interval -0.9 to -0.2
Change From Baseline in Components of ESSDAI Day 29: Glandular	-0.2 Score on a Scale Interval -0.4 to 0.0	-0.2 Score on a Scale Interval -0.4 to 0.0
Change From Baseline in Components of ESSDAI Day 29: Articular	-0.4 Score on a Scale Interval -0.8 to 0.0	-0.3 Score on a Scale Interval -0.7 to 0.1
Change From Baseline in Components of ESSDAI Day 29: Cutaneous	-0.3 Score on a Scale Interval -0.6 to 0.0	-0.2 Score on a Scale Interval -0.5 to 0.1
Change From Baseline in Components of ESSDAI Day 29: Pulmonary	0.0 Score on a Scale Interval -0.3 to 0.3	0.1 Score on a Scale Interval -0.2 to 0.4
Change From Baseline in Components of ESSDAI Day 29: Renal	-0.0 Score on a Scale Interval -0.2 to 0.2	-0.2 Score on a Scale Interval -0.3 to 0.0
Change From Baseline in Components of ESSDAI Day 29: Muscular	-0.0 Score on a Scale Interval -0.1 to 0.1	-0.0 Score on a Scale Interval -0.1 to 0.1
Change From Baseline in Components of ESSDAI Day 29: Haematogical	0.2 Score on a Scale Interval 0.0 to 0.4	0.1 Score on a Scale Interval -0.1 to 0.4
Change From Baseline in Components of ESSDAI Day 29: Biological	0.1 Score on a Scale Interval -0.1 to 0.2	0.1 Score on a Scale Interval 0.0 to 0.3
Change From Baseline in Components of ESSDAI Day 57: Constitutional	-0.2 Score on a Scale Interval -0.4 to 0.0	-0.3 Score on a Scale Interval -0.5 to -0.1
Change From Baseline in Components of ESSDAI Day 57: Lymphadenopathy	-0.7 Score on a Scale Interval -1.1 to -0.2	-0.6 Score on a Scale Interval -1.0 to -0.2
Change From Baseline in Components of ESSDAI Day 57: Glandular	-0.4 Score on a Scale Interval -0.7 to -0.2	-0.4 Score on a Scale Interval -0.6 to -0.1
Change From Baseline in Components of ESSDAI Day 57: Articular	-0.7 Score on a Scale Interval -1.1 to -0.3	-0.8 Score on a Scale Interval -1.2 to -0.4
Change From Baseline in Components of ESSDAI Day 57: Cutaneous	-0.3 Score on a Scale Interval -0.6 to 0.0	-0.2 Score on a Scale Interval -0.5 to 0.1
Change From Baseline in Components of ESSDAI Day 57: Pulmonary	-0.0 Score on a Scale Interval -0.3 to 0.3	0.2 Score on a Scale Interval -0.1 to 0.5
Change From Baseline in Components of ESSDAI Day 57: Renal	-0.0 Score on a Scale Interval -0.2 to 0.2	-0.1 Score on a Scale Interval -0.3 to 0.1
Change From Baseline in Components of ESSDAI Day 57: Muscular	-0.0 Score on a Scale Interval -0.1 to 0.1	-0.1 Score on a Scale Interval -0.2 to 0.0
Change From Baseline in Components of ESSDAI Day 57: Peripheral Nervous System	-0.0 Score on a Scale Interval -0.2 to 0.2	0.0 Score on a Scale Interval -0.2 to 0.2
Change From Baseline in Components of ESSDAI Day 57: Haematological	0.1 Score on a Scale Interval -0.1 to 0.4	0.2 Score on a Scale Interval 0.0 to 0.4
Change From Baseline in Components of ESSDAI Day 57: Biological	-0.1 Score on a Scale Interval -0.2 to 0.1	0.0 Score on a Scale Interval -0.1 to 0.2
Change From Baseline in Components of ESSDAI Day 85: Constitutional	-0.3 Score on a Scale Interval -0.5 to -0.1	-0.4 Score on a Scale Interval -0.6 to -0.2
Change From Baseline in Components of ESSDAI Day 85: Lymphadenopathy	-0.7 Score on a Scale Interval -1.1 to -0.3	-0.8 Score on a Scale Interval -1.2 to -0.4
Change From Baseline in Components of ESSDAI Day 85: Glandular	-0.4 Score on a Scale Interval -0.6 to -0.1	-0.5 Score on a Scale Interval -0.7 to -0.2
Change From Baseline in Components of ESSDAI Day 85: Articular	-1.0 Score on a Scale Interval -1.5 to -0.6	-1.1 Score on a Scale Interval -1.6 to -0.7
Change From Baseline in Components of ESSDAI Day 85: Cutaneous	-0.4 Score on a Scale Interval -0.7 to 0.0	-0.2 Score on a Scale Interval -0.5 to 0.1
Change From Baseline in Components of ESSDAI Day 85: Pulmonary	0.0 Score on a Scale Interval -0.3 to 0.4	0.2 Score on a Scale Interval -0.1 to 0.5
Change From Baseline in Components of ESSDAI Day 85: Renal	-0.1 Score on a Scale Interval -0.3 to 0.1	-0.1 Score on a Scale Interval -0.3 to 0.1
Change From Baseline in Components of ESSDAI Day 85: Muscular	-0.1 Score on a Scale Interval -0.2 to 0.0	-0.0 Score on a Scale Interval -0.1 to 0.1
Change From Baseline in Components of ESSDAI Day 85: Peripheral Nervous System	-0.0 Score on a Scale Interval -0.2 to 0.2	0.0 Score on a Scale Interval -0.2 to 0.2
Change From Baseline in Components of ESSDAI Day 85: Haematological	0.1 Score on a Scale Interval -0.1 to 0.3	0.2 Score on a Scale Interval -0.1 to 0.4
Change From Baseline in Components of ESSDAI Day 85: Biological	0.0 Score on a Scale Interval -0.1 to 0.2	0.2 Score on a Scale Interval 0.0 to 0.3
Change From Baseline in Components of ESSDAI Day 113: Constitutional	-0.3 Score on a Scale Interval -0.5 to 0.0	-0.3 Score on a Scale Interval -0.5 to -0.1
Change From Baseline in Components of ESSDAI Day 113: Lymphadenopathy	-0.8 Score on a Scale Interval -1.2 to -0.4	-0.9 Score on a Scale Interval -1.3 to -0.5
Change From Baseline in Components of ESSDAI Day 113: Glandular	-0.5 Score on a Scale Interval -0.7 to -0.3	-0.5 Score on a Scale Interval -0.8 to -0.3
Change From Baseline in Components of ESSDAI Day 113: Articular	-1.3 Score on a Scale Interval -1.8 to -0.8	-1.3 Score on a Scale Interval -1.7 to -0.8
Change From Baseline in Components of ESSDAI Day 113: Cutaneous	-0.4 Score on a Scale Interval -0.7 to -0.1	-0.4 Score on a Scale Interval -0.7 to -0.1
Change From Baseline in Components of ESSDAI Day 113: Pulmonary	0.0 Score on a Scale Interval -0.3 to 0.4	0.1 Score on a Scale Interval -0.2 to 0.5
Change From Baseline in Components of ESSDAI Day 113: Renal	-0.1 Score on a Scale Interval -0.3 to 0.1	0.0 Score on a Scale Interval -0.2 to 0.2
Change From Baseline in Components of ESSDAI Day 113: Muscular	-0.0 Score on a Scale Interval -0.1 to 0.1	-0.1 Score on a Scale Interval -0.2 to 0.0
Change From Baseline in Components of ESSDAI Day 113: Haematological	0.1 Score on a Scale Interval -0.2 to 0.3	0.2 Score on a Scale Interval 0.0 to 0.4
Change From Baseline in Components of ESSDAI Day 113: Biological	-0.0 Score on a Scale Interval -0.2 to 0.1	0.1 Score on a Scale Interval 0.0 to 0.3
Change From Baseline in Components of ESSDAI Day 141: Constitutional	-0.2 Score on a Scale Interval -0.4 to 0.0	-0.4 Score on a Scale Interval -0.6 to -0.2
Change From Baseline in Components of ESSDAI Day 141: Glandular	-0.5 Score on a Scale Interval -0.7 to -0.2	-0.6 Score on a Scale Interval -0.8 to -0.4
Change From Baseline in Components of ESSDAI Day 141: Articular	-1.2 Score on a Scale Interval -1.7 to -0.8	-1.4 Score on a Scale Interval -1.9 to -1.0
Change From Baseline in Components of ESSDAI Day 141: Pulmonary	-0.0 Score on a Scale Interval -0.4 to 0.3	0.1 Score on a Scale Interval -0.2 to 0.4
Change From Baseline in Components of ESSDAI Day 141: Muscular	-0.1 Score on a Scale Interval -0.2 to 0.0	-0.1 Score on a Scale Interval -0.2 to 0.0
Change From Baseline in Components of ESSDAI Day 141: Haematological	0.1 Score on a Scale Interval -0.1 to 0.4	0.1 Score on a Scale Interval -0.1 to 0.4
Change From Baseline in Components of ESSDAI Day 169: Constitutional	-0.3 Score on a Scale Interval -0.5 to -0.1	-0.4 Score on a Scale Interval -0.6 to -0.2
Change From Baseline in Components of ESSDAI Day 169: Lymphadenopathy	-0.9 Score on a Scale Interval -1.3 to -0.5	-1.1 Score on a Scale Interval -1.4 to -0.7
Change From Baseline in Components of ESSDAI Day 169: Glandular	-0.4 Score on a Scale Interval -0.6 to -0.1	-0.5 Score on a Scale Interval -0.8 to -0.3
Change From Baseline in Components of ESSDAI Day 169: Articular	-1.4 Score on a Scale Interval -1.8 to -0.9	-1.8 Score on a Scale Interval -2.2 to -1.4
Change From Baseline in Components of ESSDAI Day 169: Cutaneous	-0.3 Score on a Scale Interval -0.7 to 0.0	-0.5 Score on a Scale Interval -0.9 to -0.2
Change From Baseline in Components of ESSDAI Day 169: Muscular	-0.0 Score on a Scale Interval -0.1 to 0.1	-0.1 Score on a Scale Interval -0.2 to 0.0
Change From Baseline in Components of ESSDAI Day 169: Peripheral Nervous	-0.1 Score on a Scale Interval -0.3 to 0.1	-0.0 Score on a Scale Interval -0.2 to 0.2
Change From Baseline in Components of ESSDAI Day 169: Haematological	0.1 Score on a Scale Interval -0.2 to 0.3	0.3 Score on a Scale Interval 0.1 to 0.5
Change From Baseline in Components of ESSDAI Day 169: Biological	0.0 Score on a Scale Interval -0.1 to 0.2	0.2 Score on a Scale Interval 0.0 to 0.3
Change From Baseline in Components of ESSDAI Day 29: Constitutional	-0.3 Score on a Scale Interval -0.4 to -0.1	-0.4 Score on a Scale Interval -0.5 to -0.2
Change From Baseline in Components of ESSDAI Day 29: Peripheral Nervous System	-0.0 Score on a Scale Interval -0.2 to 0.2	0.0 Score on a Scale Interval -0.2 to 0.2
Change From Baseline in Components of ESSDAI Day 113: Peripheral Nervous System	-0.0 Score on a Scale Interval -0.2 to 0.2	-0.0 Score on a Scale Interval -0.2 to 0.1
Change From Baseline in Components of ESSDAI Day 141: Lymphadenopathy	-0.6 Score on a Scale Interval -1.1 to -0.2	-0.9 Score on a Scale Interval -1.4 to -0.5
Change From Baseline in Components of ESSDAI Day 141: Cutaneous	-0.4 Score on a Scale Interval -0.7 to -0.1	-0.5 Score on a Scale Interval -0.8 to -0.3
Change From Baseline in Components of ESSDAI Day 141: Renal	-0.0 Score on a Scale Interval -0.2 to 0.2	-0.1 Score on a Scale Interval -0.3 to 0.1
Change From Baseline in Components of ESSDAI Day 141: Peripheral Nervous System	-0.1 Score on a Scale Interval -0.3 to 0.1	-0.0 Score on a Scale Interval -0.2 to 0.1
Change From Baseline in Components of ESSDAI Day 141: Biological	-0.0 Score on a Scale Interval -0.2 to 0.1	0.1 Score on a Scale Interval 0.0 to 0.2
Change From Baseline in Components of ESSDAI Day 169: Pulmonary	-0.0 Score on a Scale Interval -0.4 to 0.3	0.1 Score on a Scale Interval -0.2 to 0.4
Change From Baseline in Components of ESSDAI Day 169: Renal	-0.0 Score on a Scale Interval -0.2 to 0.2	0.0 Score on a Scale Interval -0.2 to 0.2

SECONDARY outcome

Timeframe: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Population: Modified ITT Population

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in ESSPRI Components Day 29: Dryness Score	-0.21 Score on a Scale Interval -0.76 to 0.34	-0.26 Score on a Scale Interval -0.8 to 0.28
Change From Baseline in ESSPRI Components Day 29: Fatigue Score	-0.57 Score on a Scale Interval -1.18 to 0.03	-1.01 Score on a Scale Interval -1.6 to -0.42
Change From Baseline in ESSPRI Components Day 29: Pain Score	-0.34 Score on a Scale Interval -0.96 to 0.27	-0.53 Score on a Scale Interval -1.13 to 0.07
Change From Baseline in ESSPRI Components Day 57: Dryness Score	-0.92 Score on a Scale Interval -1.51 to -0.33	-0.52 Score on a Scale Interval -1.09 to 0.05
Change From Baseline in ESSPRI Components Day 57: Pain Score	-0.60 Score on a Scale Interval -1.24 to 0.05	-0.90 Score on a Scale Interval -1.52 to -0.27
Change From Baseline in ESSPRI Components Day 85: Dryness Score	-0.68 Score on a Scale Interval -1.25 to -0.11	-0.91 Score on a Scale Interval -1.46 to -0.36
Change From Baseline in ESSPRI Components Day 85: Fatigue Score	-1.27 Score on a Scale Interval -1.91 to -0.63	-1.56 Score on a Scale Interval -2.18 to -0.94
Change From Baseline in ESSPRI Components Day 85: Pain Score	-0.70 Score on a Scale Interval -1.35 to -0.05	-1.31 Score on a Scale Interval -1.93 to -0.68
Change From Baseline in ESSPRI Components Day 113: Dryness Score	-0.74 Score on a Scale Interval -1.36 to -0.12	-1.19 Score on a Scale Interval -1.79 to -0.6
Change From Baseline in ESSPRI Components Day 113: Fatigue Score	-1.02 Score on a Scale Interval -1.65 to -0.39	-1.76 Score on a Scale Interval -2.37 to -1.15
Change From Baseline in ESSPRI Components Day 113: Pain Score	-0.76 Score on a Scale Interval -1.4 to -0.11	-1.37 Score on a Scale Interval -1.99 to -0.74
Change From Baseline in ESSPRI Components Day 141: Dryness Score	-0.89 Score on a Scale Interval -1.49 to -0.28	-1.05 Score on a Scale Interval -1.63 to -0.46
Change From Baseline in ESSPRI Components Day 141: Fatigue Score	-1.18 Score on a Scale Interval -1.83 to -0.53	-1.73 Score on a Scale Interval -2.36 to -1.11
Change From Baseline in ESSPRI Components Day 141: Pain Score	-0.70 Score on a Scale Interval -1.34 to -0.07	-1.39 Score on a Scale Interval -2.0 to -0.78
Change From Baseline in ESSPRI Components Day 169: Dryness Score	-0.84 Score on a Scale Interval -1.46 to -0.23	-1.04 Score on a Scale Interval -1.63 to -0.44
Change From Baseline in ESSPRI Components Day 169: Fatigue Score	-1.28 Score on a Scale Interval -1.93 to -0.64	-1.57 Score on a Scale Interval -2.19 to -0.95
Change From Baseline in ESSPRI Components Day 169: Pain Score	-1.11 Score on a Scale Interval -1.75 to -0.47	-1.45 Score on a Scale Interval -2.06 to -0.83
Change From Baseline in ESSPRI Components Day 57: Fatigue Score	-1.09 Score on a Scale Interval -1.7 to -0.48	-1.22 Score on a Scale Interval -1.81 to -0.63

SECONDARY outcome

Timeframe: Day 85, Day 169

Population: Modified ITT Population

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.

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in Schirmer's Test Day 85: Study Eye	1.9 millimeters Interval 0.0 to 3.9	1.5 millimeters Interval -0.5 to 3.5
Change From Baseline in Schirmer's Test Day 85: Non-Study Eye	0.1 millimeters Interval -2.0 to 2.2	0.8 millimeters Interval -1.2 to 2.9
Change From Baseline in Schirmer's Test Day 85: Average of Both Eyes	1.10 millimeters Interval -0.75 to 2.96	1.41 millimeters Interval -0.43 to 3.24
Change From Baseline in Schirmer's Test Day 169: Study Eye	1.7 millimeters Interval -0.4 to 3.9	1.0 millimeters Interval -1.1 to 3.2
Change From Baseline in Schirmer's Test Day 169: Non-Study Eye	0.6 millimeters Interval -1.3 to 2.4	0.2 millimeters Interval -1.7 to 2.1
Change From Baseline in Schirmer's Test Day 169: Average of Both Eyes	1.21 millimeters Interval -0.59 to 3.0	0.82 millimeters Interval -0.97 to 2.61

SECONDARY outcome

Timeframe: Day 85, Day 169

Population: Modified ITT Population

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) \[score scale: 0 - 1\]

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in the Ocular Staining Score (OSS) Day 85: Non-Study Eye	-0.6 Score on a Scale Interval -1.4 to 0.2	0.4 Score on a Scale Interval -0.4 to 1.2
Change From Baseline in the Ocular Staining Score (OSS) Day 85: Average of Both Eyes	-1.15 Score on a Scale Interval -1.91 to -0.39	-0.06 Score on a Scale Interval -0.81 to 0.68
Change From Baseline in the Ocular Staining Score (OSS) Day 169: Study Eye	-1.5 Score on a Scale Interval -2.3 to -0.6	-0.7 Score on a Scale Interval -1.6 to 0.1
Change From Baseline in the Ocular Staining Score (OSS) Day 169: Non-Study Eye	-0.5 Score on a Scale Interval -1.3 to 0.3	0.3 Score on a Scale Interval -0.5 to 1.2
Change From Baseline in the Ocular Staining Score (OSS) Day 169: Average of Both Eyes	-0.99 Score on a Scale Interval -1.79 to -0.19	-0.19 Score on a Scale Interval -0.98 to 0.6
Change From Baseline in the Ocular Staining Score (OSS) Day 85: Study Eye	-1.7 Score on a Scale Interval -2.5 to -0.9	-0.5 Score on a Scale Interval -1.3 to 0.3

SECONDARY outcome

Timeframe: Day 85, Day 169

Population: Modified ITT Population

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.

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in Tear Break-up Time Day 85: Non-Study Eye	-0.70 Seconds Interval -1.59 to 0.18	-0.12 Seconds Interval -1.01 to 0.76
Change From Baseline in Tear Break-up Time Day 85: Average of Both Eyes	-0.41 Seconds Interval -1.24 to 0.43	0.09 Seconds Interval -0.74 to 0.92
Change From Baseline in Tear Break-up Time Day 169: Study Eye	-0.23 Seconds Interval -1.11 to 0.64	-0.32 Seconds Interval -1.19 to 0.56
Change From Baseline in Tear Break-up Time Day 169: Non-Study Eye	-0.79 Seconds Interval -1.62 to 0.03	-0.62 Seconds Interval -1.46 to 0.21
Change From Baseline in Tear Break-up Time Day 169: Average of Both Eyes	-0.50 Seconds Interval -1.32 to 0.31	-0.43 Seconds Interval -1.25 to 0.39
Change From Baseline in Tear Break-up Time Day 85: Study Eye	-0.13 Seconds Interval -0.99 to 0.73	0.18 Seconds Interval -0.67 to 1.04

SECONDARY outcome

Timeframe: Day 85, Day 169

Population: Modified ITT Population

The mean change from baseline in unstimulated whole salivary flow at all measured time points up to Day 169.

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in Unstimulated Salivary Flow Day 85	0.106 mL/min Interval -0.037 to 0.249	0.158 mL/min Interval 0.022 to 295.0
Change From Baseline in Unstimulated Salivary Flow Day 169	0.051 mL/min Interval -0.1 to 0.203	0.105 mL/min Interval -0.042 to 0.251

SECONDARY outcome

Timeframe: Day 85, Day 169

Population: Modified ITT Population

The mean change from baseline in Stimulated whole salivary flow at all measured time points up to Day 169.

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=88 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=88 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in Stimulated Salivary Flow Day 85	0.11 mL/min Interval -0.039 to 0.262	0.169 mL/min Interval 0.024 to 0.314
Change From Baseline in Stimulated Salivary Flow Day 169	0.056 mL/min Interval -0.104 to 0.216	0.108 mL/min Interval -0.048 to 0.263

SECONDARY outcome

Timeframe: Day 1, 29, 57, 85, 113, 141, 169

Population: Modified ITT Population

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

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in Numeric Rating Scale for Mouth Dryness Day 29	-0.8 Score on a Scale Interval -8.0 to 3.0	-0.5 Score on a Scale Interval -7.0 to 6.0
Change From Baseline in Numeric Rating Scale for Mouth Dryness Day 57	-1.3 Score on a Scale Interval -8.0 to 5.0	-0.9 Score on a Scale Interval -7.0 to 6.0
Change From Baseline in Numeric Rating Scale for Mouth Dryness Day 85	-1.3 Score on a Scale Interval -9.0 to 4.0	-1.1 Score on a Scale Interval -6.0 to 8.0
Change From Baseline in Numeric Rating Scale for Mouth Dryness Day 113	-1.2 Score on a Scale Interval -9.0 to 3.0	-1.3 Score on a Scale Interval -8.0 to 4.0
Change From Baseline in Numeric Rating Scale for Mouth Dryness Day 141	-1.3 Score on a Scale Interval -8.0 to 5.0	-1.1 Score on a Scale Interval -6.0 to 6.0
Change From Baseline in Numeric Rating Scale for Mouth Dryness Day 169	-1.3 Score on a Scale Interval -8.0 to 3.0	-1.2 Score on a Scale Interval -6.0 to 8.0

SECONDARY outcome

Timeframe: Day 1, 29, 57, 85, 113, 141, 169

Population: Modified ITT Population

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

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in Numeric Rating Scale for Eye Dryness Day 29	-0.4 Score on a Scale Interval -8.0 to 5.0	-0.3 Score on a Scale Interval -6.0 to 5.0
Change From Baseline in Numeric Rating Scale for Eye Dryness Day 57	-0.9 Score on a Scale Interval -7.0 to 5.0	-0.6 Score on a Scale Interval -6.0 to 5.0
Change From Baseline in Numeric Rating Scale for Eye Dryness Day 85	-0.9 Score on a Scale Interval -7.0 to 6.0	-0.8 Score on a Scale Interval -7.0 to 8.0
Change From Baseline in Numeric Rating Scale for Eye Dryness Day 113	-1.0 Score on a Scale Interval -7.0 to 7.0	-1.1 Score on a Scale Interval -8.0 to 4.0
Change From Baseline in Numeric Rating Scale for Eye Dryness Day 141	-0.8 Score on a Scale Interval -7.0 to 7.0	-1.0 Score on a Scale Interval -7.0 to 4.0
Change From Baseline in Numeric Rating Scale for Eye Dryness Day 169	-0.9 Score on a Scale Interval -5.0 to 6.0	-1.0 Score on a Scale Interval -7.0 to 5.0

SECONDARY outcome

Timeframe: Day 29, 57, 85, 113, 141, 169

Population: Modified ITT Population

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

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in Participant Assessment of Disease Activity Day 29	-4.0 Score on VAS 0-100mm scale Interval -9.8 to 1.7	-7.1 Score on VAS 0-100mm scale Interval -12.7 to -1.4
Change From Baseline in Participant Assessment of Disease Activity Day 57	-7.5 Score on VAS 0-100mm scale Interval -13.4 to -1.7	-6.3 Score on VAS 0-100mm scale Interval -11.9 to -0.6
Change From Baseline in Participant Assessment of Disease Activity Day 85	-10.4 Score on VAS 0-100mm scale Interval -16.3 to -4.4	-10.2 Score on VAS 0-100mm scale Interval -16.0 to -4.4
Change From Baseline in Participant Assessment of Disease Activity Day 113	-8.0 Score on VAS 0-100mm scale Interval -14.0 to -2.0	-9.7 Score on VAS 0-100mm scale Interval -15.5 to -3.9
Change From Baseline in Participant Assessment of Disease Activity Day 141	-5.1 Score on VAS 0-100mm scale Interval -11.0 to 0.8	-11.0 Score on VAS 0-100mm scale Interval -16.7 to -5.3
Change From Baseline in Participant Assessment of Disease Activity Day 169	-10.1 Score on VAS 0-100mm scale Interval -16.1 to -4.0	-9.0 Score on VAS 0-100mm scale Interval -14.8 to -3.1

SECONDARY outcome

Timeframe: Day 29, 57, 85, 113, 141, 169

Population: Modified ITT Population

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

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in Physician Global Assessment of Disease Activity Day 29	-10.3 Score on VAS 0-100mm Scale Interval -14.8 to -5.8	-10.5 Score on VAS 0-100mm Scale Interval -14.9 to -6.1
Change From Baseline in Physician Global Assessment of Disease Activity Day 57	-16.2 Score on VAS 0-100mm Scale Interval -20.8 to -11.7	-16.7 Score on VAS 0-100mm Scale Interval -21.1 to -12.3
Change From Baseline in Physician Global Assessment of Disease Activity Day 85	-20.8 Score on VAS 0-100mm Scale Interval -25.6 to -16.0	-19.4 Score on VAS 0-100mm Scale Interval -24.0 to -14.7
Change From Baseline in Physician Global Assessment of Disease Activity Day 113	-22.8 Score on VAS 0-100mm Scale Interval -27.9 to -17.8	-19.8 Score on VAS 0-100mm Scale Interval -24.6 to -14.9
Change From Baseline in Physician Global Assessment of Disease Activity Day 141	-23.7 Score on VAS 0-100mm Scale Interval -28.6 to -18.8	-21.7 Score on VAS 0-100mm Scale Interval -26.5 to -17.0
Change From Baseline in Physician Global Assessment of Disease Activity Day 169	-23.0 Score on VAS 0-100mm Scale Interval -27.8 to -18.2	-23.7 Score on VAS 0-100mm Scale Interval -28.3 to -19.0

SECONDARY outcome

Timeframe: Day 29, 57, 85, 113, 141, 169

Population: Modified ITT Population

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

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in Patient Fatigue Day 29	-3.08 T-Score Interval -5.22 to -0.95	-3.99 T-Score Interval -6.09 to -1.88
Change From Baseline in Patient Fatigue Day 57	-4.12 T-Score Interval -6.27 to -1.97	-4.02 T-Score Interval -6.12 to -1.91
Change From Baseline in Patient Fatigue Day 85	-4.85 T-Score Interval -7.05 to -2.64	-5.48 T-Score Interval -7.64 to -3.32
Change From Baseline in Patient Fatigue Day 113	-4.17 T-Score Interval -6.37 to -1.97	-5.32 T-Score Interval -7.48 to -3.17
Change From Baseline in Patient Fatigue Day 141	-4.84 T-Score Interval -7.06 to -2.62	-5.68 T-Score Interval -7.85 to -3.52
Change From Baseline in Patient Fatigue Day 169	-5.56 T-Score Interval -7.83 to -3.28	-5.59 T-Score Interval -7.82 to -3.37

SECONDARY outcome

Timeframe: Day 85, Day 169

Population: Modified ITT Population

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

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=88 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=88 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI) Day 85	-2.44 Scores on a Scale Interval -5.67 to 0.78	-1.56 Scores on a Scale Interval -4.9 to 1.77
Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI) Day 169	-2.32 Scores on a Scale Interval -5.73 to 1.09	-1.87 Scores on a Scale Interval -5.42 to 1.68

SECONDARY outcome

Timeframe: Day 85, Day 169

Population: Modified ITT Population

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

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 85: Physical Function	1.908 Score on a Scale Interval -0.24 to 4.056	1.523 Score on a Scale Interval -0.568 to 3.614
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 85: Role Physical	5.248 Score on a Scale Interval 3.112 to 7.383	4.416 Score on a Scale Interval 2.321 to 6.511
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 85: Bodily Pain	3.200 Score on a Scale Interval 0.91 to 5.49	3.721 Score on a Scale Interval 1.464 to 5.978
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 85: General Health	4.042 Score on a Scale Interval 1.938 to 6.146	3.409 Score on a Scale Interval 1.363 to 5.456
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 85: Vitality	3.827 Score on a Scale Interval 1.269 to 6.384	3.859 Score on a Scale Interval 1.335 to 6.382
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 85: Social Functioning	3.020 Score on a Scale Interval 0.296 to 5.744	4.771 Score on a Scale Interval 2.117 to 7.426
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 85: Role-Emotional	3.024 Score on a Scale Interval 0.214 to 5.834	4.834 Score on a Scale Interval 2.093 to 7.576
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 85: Mental Health	2.942 Score on a Scale Interval 0.458 to 5.425	2.287 Score on a Scale Interval -0.135 to 4.709
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 85: Physical component Summary	3.430 Score on a Scale Interval 1.615 to 5.244	2.686 Score on a Scale Interval 0.904 to 4.468
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 85: Mental component Summary	2.693 Score on a Scale Interval 0.16 to 5.226	3.672 Score on a Scale Interval 1.208 to 6.136
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 169: Physical Function	2.927 Score on a Scale Interval 0.593 to 5.261	1.742 Score on a Scale Interval -0.505 to 3.989
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 169: Role-Physical	5.853 Score on a Scale Interval 3.756 to 7.949	4.626 Score on a Scale Interval 2.604 to 6.649
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 169: Bodily Pain	3.842 Score on a Scale Interval 1.432 to 6.252	3.458 Score on a Scale Interval 1.114 to 5.801
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 169: General Health	3.880 Score on a Scale Interval 1.7 to 6.06	3.764 Score on a Scale Interval 1.665 to 5.862
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 169: Vitality	3.742 Score on a Scale Interval 1.16 to 6.324	4.523 Score on a Scale Interval 2.005 to 7.041
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 169: Social functioning	4.125 Score on a Scale Interval 1.32 to 6.929	4.471 Score on a Scale Interval 1.773 to 7.169
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 169: Mental Health	2.375 Score on a Scale Interval -0.116 to 4.866	2.972 Score on a Scale Interval 0.581 to 5.363
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 169: Physical Component Summary	3.998 Score on a Scale Interval 2.045 to 5.951	2.650 Score on a Scale Interval 0.756 to 4.543
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 169: Role-Emotional	4.653 Score on a Scale Interval 1.943 to 7.364	4.930 Score on a Scale Interval 2.334 to 7.526
Change From Baseline in 36-item Short Form Health Survey (SF-36) Day 169: Mental Component Summary	2.940 Score on a Scale Interval 0.368 to 5.512	4.112 Score on a Scale Interval 1.648 to 6.577

SECONDARY outcome

Timeframe: Day 29, 85, 113, 141, 169

Population: Pharmacokinetic (PK) Evaluable Population

Geometric mean of trough concentration (Cmin) of abatacept at all measured time points.

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Geometric Mean of Trough Concentration (Cmin) of Abatacept Day 29	21.401 µg/mL Geometric Coefficient of Variation 36	—
Geometric Mean of Trough Concentration (Cmin) of Abatacept Day 85	27.543 µg/mL Geometric Coefficient of Variation 38.4	—
Geometric Mean of Trough Concentration (Cmin) of Abatacept Day 113	25.567 µg/mL Geometric Coefficient of Variation 42.1	—
Geometric Mean of Trough Concentration (Cmin) of Abatacept Day 141	25.870 µg/mL Geometric Coefficient of Variation 40.8	—
Geometric Mean of Trough Concentration (Cmin) of Abatacept Day 169	24.522 µg/mL Geometric Coefficient of Variation 42.7	—

SECONDARY outcome

Timeframe: Day 85 db, day 169 db, post treatment day 85

Population: Immunogenicity Analysis Population

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).

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=90 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=43 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Percentage of Participants With a Positive Antibody Response Study Day 169	1.2 Percentage	—
Percentage of Participants With a Positive Antibody Response Post Treatment Day 85 (DB)	0 Percentage	—
Percentage of Participants With a Positive Antibody Response Post Treatment Day 169 (DB)	0 Percentage	—

SECONDARY outcome

Timeframe: 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.

Population: As-Treated Population

Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=92 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Summary of Adverse Events: Double Blind Period Adverse Events (AEs)	85.9 Percentage	71.6 Percentage
Summary of Adverse Events: Double Blind Period Deaths	0 Percentage	1.1 Percentage
Summary of Adverse Events: Double Blind Period Serious Adverse Events	9.8 Percentage	3.2 Percentage
Summary of Adverse Events: Double Blind Period Discontinuation due to AEs	3.3 Percentage	2.1 Percentage

SECONDARY outcome

Timeframe: Day 1 up to first dose of OL abatacept or up to 56 post last dose in double -blind for those not in OL.

Population: As-Treated Analysis Population

Laboratory values meeting the marked abnormality criteria

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=91 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 Participants Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Laboratory Marked Abnormalities: Double Blind Period Hematocrit High	NA Percentage Not Evaluated	NA Percentage Not Evaluated
Laboratory Marked Abnormalities: Double Blind Period Hematocrit Low	0 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period Hemoglobin High	NA Percentage Not Evaluated	NA Percentage Not Evaluated
Laboratory Marked Abnormalities: Double Blind Period Hemoglobin Low	0 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period Platelet count High	0 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period Platelet count low	0 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period Leukocytes high	1.1 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period Basophils high	0 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period Basophils Low	NA Percentage Not Evaluated	NA Percentage Not Evaluated
Laboratory Marked Abnormalities: Double Blind Period Eosinophils High	4.4 Percentage	1.1 Percentage
Laboratory Marked Abnormalities: Double Blind Period Eosinophils Low	NA Percentage Not Evaluated	NA Percentage Not Evaluated
Laboratory Marked Abnormalities: Double Blind Period lymphocytes high	0 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period lymphocytes low	9.9 Percentage	14.7 Percentage
Laboratory Marked Abnormalities: Double Blind Period Monocytes high	0 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period Monocytes Low	NA Percentage Not Evaluated	NA Percentage Not Evaluated
Laboratory Marked Abnormalities: Double Blind Period Neutrophils+Bands High	NA Percentage Not Evaluated	NA Percentage Not Evaluated
Laboratory Marked Abnormalities: Double Blind Period Neutrophils+Bands Low	6.6 Percentage	1.1 Percentage
Laboratory Marked Abnormalities: Double Blind Period Alanine Aminotransferase High	1.1 Percentage	2.1 Percentage
Laboratory Marked Abnormalities: Double Blind Period Alkaline Phosphatase HIgh	0 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period Aspartate Aminotransferase High	1.1 Percentage	3.2 Percentage
Laboratory Marked Abnormalities: Double Blind Period Blood Urea Nitrogen High	1.1 Percentage	1.1 Percentage
Laboratory Marked Abnormalities: Double Blind Period Creatinine High	0 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period Calcium High	0 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period Calcium Low	1.1 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period Chloride High	0 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period Chloride Low	1.1 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period Phosphorus High	0 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period Phosphorus Low	0 Percentage	1.1 Percentage
Laboratory Marked Abnormalities: Double Blind Period Potassium High	0 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period Potassium Low	1.1 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period Glucose, Urine Low	NA Percentage Not Evaluated	NA Percentage Not Evaluated
Laboratory Marked Abnormalities: Double Blind Period Protein, Urine High	2.2 Percentage	3.2 Percentage
Laboratory Marked Abnormalities: Double Blind Period Leukocytes low	12.1 Percentage	8.4 Percentage
Laboratory Marked Abnormalities: Double Blind Period Bilirubin, Total High	0 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period G-Glutamyl Transferase High	6.6 Percentage	1.1 Percentage
Laboratory Marked Abnormalities: Double Blind Period Sodium High	0 Percentage	1.1 Percentage
Laboratory Marked Abnormalities: Double Blind Period Sodium Low	2.2 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period Glucose, Serum High	0 Percentage	1.1 Percentage
Laboratory Marked Abnormalities: Double Blind Period Glucose, Serum Low	2.2 Percentage	5.3 Percentage
Laboratory Marked Abnormalities: Double Blind Period Albumin High	NA Percentage Not Evaluated	NA Percentage Not Evaluated
Laboratory Marked Abnormalities: Double Blind Period Albumin Low	2.2 Percentage	1.1 Percentage
Laboratory Marked Abnormalities: Double Blind Period Protein, Total High	2.2 Percentage	3.2 Percentage
Laboratory Marked Abnormalities: Double Blind Period Protein, Total Low	1.1 Percentage	0 Percentage
Laboratory Marked Abnormalities: Double Blind Period Creatine Kinase High	0 Percentage	4.2 Percentage
Laboratory Marked Abnormalities: Double Blind Period Blood, Urine High	14.3 Percentage	9.5 Percentage
Laboratory Marked Abnormalities: Double Blind Period Blood, Urine Low	NA Percentage Not Evaluated	NA Percentage Not Evaluated
Laboratory Marked Abnormalities: Double Blind Period Glucose, Urine High	0 Percentage	0 Percentage

SECONDARY outcome

Timeframe: Day 365, post open label treatment day 85

Population: Immunogenicity Analysis Population

Percentage of participants with at least one positive immunogenicity response On Day 365 (end of Open label treatment period) and day 85 post open label follow up period.

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=177 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Percentage of Participants With a Positive Antibody Response in the Cumulative Abatacept Period Study Day 365	2.1 Percentage	—
Percentage of Participants With a Positive Antibody Response in the Cumulative Abatacept Period Post Treatment Day 85 (OL)	43.2 Percentage	—

SECONDARY outcome

Timeframe: Day 365 and 3 months of follow up approximately 450 Days

Population: Cumulative Abatacept Population

Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=178 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Summary of Adverse Events: Cumulative Abatacept Period Adverse Events (AEs)	78.7 Percentage	—
Summary of Adverse Events: Cumulative Abatacept Period Deaths	0.6 Percentage	—
Summary of Adverse Events: Cumulative Abatacept Period Serious Adverse Events (SAEs)	14.6 Percentage	—
Summary of Adverse Events: Cumulative Abatacept Period Discontinuation due to AEs	5.6 Percentage	—
Summary of Adverse Events: Cumulative Abatacept Period Related Serious Adverse Events	3.4 Percentage	—
Summary of Adverse Events: Cumulative Abatacept Period Discontinued due to SAEs	3.4 Percentage	—
Summary of Adverse Events: Cumulative Abatacept Period Related AEs	40.4 Percentage	—

SECONDARY outcome

Timeframe: Day 365 and 3 months of follow up approximately 450 Days

Population: Cumulative Abatacept Population

Laboratory values meeting the marked abnormality criteria

Outcome measures

Outcome measures
Measure	Abatacept - Double Blind Treatment Period n=177 Participants Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period Double Blind Treatment Period SC injection in 1 mL pre-filled syringe
Laboratory Marked Abnormalities: Cumulative Abatacept Period Hematocrit High	NA Percentage Not Evaluated	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Hematocrit Low	0 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Hemoglobin High	NA Percentage Not Evaluated	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Hemoglobin Low	0.6 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Platelet count High	0 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Platelet count low	0.6 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Leukocytes high	0.6 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Leukocytes low	18.6 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Aspartate Aminotransferase High	1.1 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Bilirubin, Total High	0 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period G-Glutamyl Transferase High	5.6 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Blood Urea Nitrogen High	1.7 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Creatinine High	0.6 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Calcium High	0 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Calcium Low	1.1 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Chloride High	0 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Chloride Low	1.1 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Phosphorus High	0.6 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Phosphorus Low	1.1 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Potassium High	0.6 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Potassium Low	0.6 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Sodium High	0.6 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Sodium Low	1.7 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Glucose, Serum High	0.6 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Glucose, Serum Low	5.1 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Albumin High	NA Percentage Not Evaluated	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Protein, Total Low	0.6 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Creatine Kinase High	2.3 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Blood, Urine High	14.7 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Blood, Urine Low	NA Percentage Not Evaluated	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Glucose, Urine High	0 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Glucose, Urine Low	NA Percentage Not Evaluated	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Protein, Urine High	5.6 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period WBC, Urine High	100.0 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Basophils high	0.6 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Basophils Low	NA Percentage Not Evaluated	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Eosinophils High	5.6 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Eosinophils Low	NA Percentage Not Evaluated	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period lymphocytes high	0 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period lymphocytes low	12.4 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Monocytes high	0 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Monocytes Low	NA Percentage Not Evaluated	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Neutrophils+Bands High	NA Percentage Not Evaluated	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Neutrophils+Bands Low	7.3 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Alanine Aminotransferase High	1.7 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Alkaline Phosphatase HIgh	0.6 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Albumin Low	1.7 Percentage	—
Laboratory Marked Abnormalities: Cumulative Abatacept Period Protein, Total High	4.0 Percentage	—

Adverse Events

Abatacept - Double Blind Treatment Period

Serious events: 9 serious events

Other events: 47 other events

Deaths: 0 deaths

Placebo - Double Blind Treatment Period

Serious events: 3 serious events

Other events: 40 other events

Deaths: 1 deaths

Abatacept - Open Label Treatment Period

Serious events: 19 serious events

Other events: 61 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Abatacept - Double Blind Treatment Period n=92 participants at risk Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 participants at risk Double Blind Treatment Period SC injection in 1 mL pre-filled syringe	Abatacept - Open Label Treatment Period n=165 participants at risk；n=178 participants at risk Open Label Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe
Gastrointestinal disorders Abdominal pain upper	5.4% 5/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	2.4% 4/165 • First dose to 169 days past open label period
Gastrointestinal disorders Diarrhoea	12.0% 11/92 • First dose to 169 days past open label period	4.2% 4/95 • First dose to 169 days past open label period	5.5% 9/165 • First dose to 169 days past open label period
Gastrointestinal disorders Nausea	9.8% 9/92 • First dose to 169 days past open label period	4.2% 4/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Infections and infestations Nasopharyngitis	12.0% 11/92 • First dose to 169 days past open label period	18.9% 18/95 • First dose to 169 days past open label period	13.3% 22/165 • First dose to 169 days past open label period
Infections and infestations Upper respiratory tract infection	9.8% 9/92 • First dose to 169 days past open label period	7.4% 7/95 • First dose to 169 days past open label period	9.1% 15/165 • First dose to 169 days past open label period
Infections and infestations Urinary tract infection	6.5% 6/92 • First dose to 169 days past open label period	8.4% 8/95 • First dose to 169 days past open label period	7.3% 12/165 • First dose to 169 days past open label period
Musculoskeletal and connective tissue disorders Myalgia	5.4% 5/92 • First dose to 169 days past open label period	2.1% 2/95 • First dose to 169 days past open label period	2.4% 4/165 • First dose to 169 days past open label period
Nervous system disorders Headache	10.9% 10/92 • First dose to 169 days past open label period	9.5% 9/95 • First dose to 169 days past open label period	5.5% 9/165 • First dose to 169 days past open label period
Psychiatric disorders Insomnia	5.4% 5/92 • First dose to 169 days past open label period	1.1% 1/95 • First dose to 169 days past open label period	1.2% 2/165 • First dose to 169 days past open label period
Respiratory, thoracic and mediastinal disorders Cough	5.4% 5/92 • First dose to 169 days past open label period	4.2% 4/95 • First dose to 169 days past open label period	3.6% 6/165 • First dose to 169 days past open label period
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.5% 6/92 • First dose to 169 days past open label period	1.1% 1/95 • First dose to 169 days past open label period	1.2% 2/165 • First dose to 169 days past open label period

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Abatacept - Double Blind Treatment Period n=92 participants at risk Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe	Placebo - Double Blind Treatment Period n=95 participants at risk Double Blind Treatment Period SC injection in 1 mL pre-filled syringe	Abatacept - Open Label Treatment Period n=165 participants at risk；n=178 participants at risk Open Label Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe
Nervous system disorders Migraine	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Nervous system disorders Syncope	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Product Issues Device dislocation	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	1.2% 2/165 • First dose to 169 days past open label period
Cardiac disorders Acute myocardial infarction	0.00% 0/92 • First dose to 169 days past open label period	1.1% 1/95 • First dose to 169 days past open label period	0.00% 0/165 • First dose to 169 days past open label period
Cardiac disorders Angina pectoris	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Cardiac disorders Pericarditis	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Cardiac disorders Prinzmetal angina	1.1% 1/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.00% 0/165 • First dose to 169 days past open label period
Gastrointestinal disorders Colitis	0.00% 0/92 • First dose to 169 days past open label period	1.1% 1/95 • First dose to 169 days past open label period	0.00% 0/165 • First dose to 169 days past open label period
Gastrointestinal disorders Intestinal obstruction	1.1% 1/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.00% 0/165 • First dose to 169 days past open label period
General disorders Pyrexia	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
General disorders Sudden cardiac death	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Hepatobiliary disorders Cholecystitis	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Hepatobiliary disorders Cholelithiasis	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Hepatobiliary disorders Hepatic cyst ruptured	1.1% 1/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.00% 0/165 • First dose to 169 days past open label period
Immune system disorders Anaphylactoid reaction	1.1% 1/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.00% 0/165 • First dose to 169 days past open label period
Immune system disorders Drug hypersensitivity	1.1% 1/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.00% 0/165 • First dose to 169 days past open label period
Immune system disorders Haemophagocytic lymphohistiocytosis	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Infections and infestations Periorbital cellulitis	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Infections and infestations Pneumonia bacterial	1.1% 1/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.00% 0/165 • First dose to 169 days past open label period
Infections and infestations Pyelonephritis acute	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Infections and infestations Septic shock	0.00% 0/92 • First dose to 169 days past open label period	1.1% 1/95 • First dose to 169 days past open label period	0.00% 0/165 • First dose to 169 days past open label period
Injury, poisoning and procedural complications Fall	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Musculoskeletal and connective tissue disorders Arthropathy	1.1% 1/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.00% 0/165 • First dose to 169 days past open label period
Musculoskeletal and connective tissue disorders Hip deformity	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.1% 1/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.00% 0/165 • First dose to 169 days past open label period
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage 0	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	1.1% 1/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.00% 0/165 • First dose to 169 days past open label period
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Nervous system disorders Facial paralysis	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Psychiatric disorders Depression	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/92 • First dose to 169 days past open label period	0.00% 0/95 • First dose to 169 days past open label period	0.61% 1/165 • First dose to 169 days past open label period