Sjogrens Disease
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in patients with Sjögren's Syndrome.
Interventions
BIOLOGICALAbatacept
OTHERPlacebo
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score of at least 5 * Positive anti-SS-A/Ro antibody at screening * meet the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism Classification Criteria for Sjögren's Syndrome (EULAR SS)
Exclusion criteria
* Secondary Sjögrens syndrome * Active life-threatening or organ-threatening complications of Sjögren's-syndrome * Other medical condition associated with sicca syndrome Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) | Day 169 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Stimulated Whole Salivary Flow | Day 169 | The mean change from baseline in the stimulated whole salivary flow at Day 169 |
| Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population | Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | 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 |
| Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 | Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | 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 |
| Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 | Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | 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 |
| Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | 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 |
| Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population | Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | 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 |
| Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population | Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | 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 |
| Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | 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 |
| Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | 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 |
| Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | 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 |
| Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | 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 |
| Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | 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 |
| Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | 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 |
| Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points | Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | 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. |
| Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points | Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | 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. |
| Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point | Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | 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. |
| Change From Baseline at All Measured Time Points in the ESSDAI | Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | 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 |
| Change From Baseline at All Measured Time Points in the ESSPRI | Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | 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. |
| Change From Baseline in Components of ESSDAI | Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169 | 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) |
| Change From Baseline in ESSPRI Components | Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 | 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. |
| Change From Baseline in Schirmer's Test | Day 85, Day 169 | 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. |
| Change From Baseline in the Ocular Staining Score (OSS) | Day 85, Day 169 | 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) \[score scale: 0 - 1\] |
| Change From Baseline in Tear Break-up Time | Day 85, Day 169 | 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. |
| Change From Baseline in Unstimulated Salivary Flow | Day 85, Day 169 | The mean change from baseline in unstimulated whole salivary flow at all measured time points up to Day 169. |
| Change From Baseline in Stimulated Salivary Flow | Day 85, Day 169 | The mean change from baseline in Stimulated whole salivary flow at all measured time points up to Day 169. |
| Change From Baseline in Numeric Rating Scale for Mouth Dryness | Day 1, 29, 57, 85, 113, 141, 169 | 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 |
| Change From Baseline in Numeric Rating Scale for Eye Dryness | Day 1, 29, 57, 85, 113, 141, 169 | 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 |
| Change From Baseline in Participant Assessment of Disease Activity | Day 29, 57, 85, 113, 141, 169 | 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 |
| Change From Baseline in Physician Global Assessment of Disease Activity | Day 29, 57, 85, 113, 141, 169 | 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 |
| Change From Baseline in Patient Fatigue | Day 29, 57, 85, 113, 141, 169 | 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 |
| Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI) | Day 85, Day 169 | 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 |
| Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85, Day 169 | 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 |
| Geometric Mean of Trough Concentration (Cmin) of Abatacept | Day 29, 85, 113, 141, 169 | Geometric mean of trough concentration (Cmin) of abatacept at all measured time points. |
| Percentage of Participants With a Positive Antibody Response | Day 85 db, day 169 db, post treatment day 85 | 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). |
| Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI) | Day 169 | 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. |
| Laboratory Marked Abnormalities: Double Blind Period | Day 1 up to first dose of OL abatacept or up to 56 post last dose in double -blind for those not in OL. | Laboratory values meeting the marked abnormality criteria |
| Percentage of Participants With a Positive Antibody Response in the Cumulative Abatacept Period | Day 365, post open label treatment day 85 | 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. |
| Summary of Adverse Events: Cumulative Abatacept Period | Day 365 and 3 months of follow up approximately 450 Days | Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation |
| Laboratory Marked Abnormalities: Cumulative Abatacept Period | Day 365 and 3 months of follow up approximately 450 Days | Laboratory values meeting the marked abnormality criteria |
| Summary of Adverse Events: Double Blind Period | 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. | Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation |
Countries
Argentina, Australia, Brazil, Czechia, France, Germany, Italy, Japan, Mexico, Puerto Rico, South Korea, Sweden, United States
Participant flow
Pre-assignment details
250 enrolled; 188 Randomized, 62 not Randomized:Reasons Not randomized: 6 withdrew consent, 1 lost to follow-up, 49 no longer meet study criteria, 6 screening failures
Participants by arm
| Arm | Count |
|---|---|
| Abatacept - Double Blind Treatment Period Double Blind Treatment Period SC injection 125mg/mL in 1 mL pre-filled syringe | 92 |
| Placebo - Double Blind Treatment Period Double Blind Treatment Period SC injection in 1 mL pre-filled syringe | 95 |
| Total | 187 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Lack of Efficacy | 0 | 3 |
| Overall Study | Participant no longer meets criteria | 2 | 0 |
| Overall Study | Participant withdrew consent | 5 | 1 |
| Overall Study | poor/non-compliance | 1 | 0 |
| Overall Study | Request to discontinue treatment | 1 | 2 |
Baseline characteristics
| Characteristic | Placebo - Double Blind Treatment Period | Total | Abatacept - Double Blind Treatment Period |
|---|---|---|---|
| Age, Continuous | 52.9 Years STANDARD_DEVIATION 13.5 | 52.0 Years STANDARD_DEVIATION 12.9 | 51.2 Years STANDARD_DEVIATION 12.3 |
| Age, Customized ≤ 50 years | 42 Participants | 84 Participants | 42 Participants |
| Age, Customized > 50 years | 53 Participants | 103 Participants | 50 Participants |
| Age, Customized < 65 years | 73 Participants | 153 Participants | 80 Participants |
| Age, Customized ≥ 65 years | 22 Participants | 34 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 7 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 23 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 77 Participants | 157 Participants | 80 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 23 Participants | 44 Participants | 21 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 19 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) White | 60 Participants | 120 Participants | 60 Participants |
| Sex: Female, Male Female | 92 Participants | 177 Participants | 85 Participants |
| Sex: Female, Male Male | 3 Participants | 10 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 1 / 95 | 1 / 178 |
| other Total, other adverse events | 47 / 92 | 40 / 95 | 61 / 165 |
| serious Total, serious adverse events | 9 / 92 | 3 / 95 | 19 / 178 |
Outcome results
Primary
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain. The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm. Domain: (Score) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2) (No = No Disease Activity (DA), Low = Low DA, Moderate = Moderate DA, High = High DA) Overall score, which can range from 0 to 123, a higher score indicates more disease activity
Time frame: Day 169
Population: Modified Intent-to-treat (ITT) analysis population: all randomized participants who receive at least one dose of study medication.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) | -3.2 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) | -3.7 Score on a Scale |
p-value: 0.4421longitudinal repeated measures analysis
Secondary
Change From Baseline at All Measured Time Points in the ESSDAI
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain. The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm. Domain: (Score) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2) (No = No Disease Activity (DA), Low = Low DA, Moderate = Moderate DA, High = High DA) Overall score, which can range from 0 to 123, a higher score indicates more disease activity
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: Modified intent to treat (ITT) Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSDAI | Day 29 | -10.9 Percent Change from Baseline |
| Abatacept - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSDAI | Day 57 | -24.1 Percent Change from Baseline |
| Abatacept - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSDAI | Day 85 | -26.0 Percent Change from Baseline |
| Abatacept - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSDAI | Day 113 | -34.1 Percent Change from Baseline |
| Abatacept - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSDAI | Day 141 | -29.7 Percent Change from Baseline |
| Abatacept - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSDAI | Day 169 | -33.4 Percent Change from Baseline |
| Placebo - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSDAI | Day 141 | -37.0 Percent Change from Baseline |
| Placebo - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSDAI | Day 29 | -12.6 Percent Change from Baseline |
| Placebo - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSDAI | Day 113 | -32.1 Percent Change from Baseline |
| Placebo - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSDAI | Day 57 | -18.9 Percent Change from Baseline |
| Placebo - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSDAI | Day 169 | -37.6 Percent Change from Baseline |
| Placebo - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSDAI | Day 85 | -25.4 Percent Change from Baseline |
Secondary
Change From Baseline at All Measured Time Points in the ESSPRI
The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components. Total Score Range (0 = Best outcome and 10 = Worst Outcome) The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: Modified intent to treat (ITT) Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSPRI | Day 29 | -0.32 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSPRI | Day 57 | -0.81 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSPRI | Day 85 | -0.83 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSPRI | Day 113 | -0.79 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSPRI | Day 141 | -0.87 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSPRI | Day 169 | -1.03 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSPRI | Day 141 | -1.32 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSPRI | Day 29 | -0.54 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSPRI | Day 113 | -1.37 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSPRI | Day 57 | -0.82 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSPRI | Day 169 | -1.30 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline at All Measured Time Points in the ESSPRI | Day 85 | -1.20 Score on a Scale |
Secondary
Change From Baseline in 36-item Short Form Health Survey (SF-36)
The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement
Time frame: Day 85, Day 169
Population: Modified ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: Mental component Summary | 2.693 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: Social functioning | 4.125 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: Mental Health | 2.375 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: Physical Function | 1.908 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: Physical Function | 2.927 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: Role Physical | 5.248 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: Mental Component Summary | 2.940 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: Bodily Pain | 3.200 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: Role-Physical | 5.853 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: General Health | 4.042 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: Bodily Pain | 3.842 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: Vitality | 3.827 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: Role-Emotional | 4.653 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: Social Functioning | 3.020 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: General Health | 3.880 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: Role-Emotional | 3.024 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: Physical Component Summary | 3.998 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: Mental Health | 2.942 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: Vitality | 3.742 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: Physical component Summary | 3.430 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: Vitality | 4.523 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: Role-Emotional | 4.930 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: Mental Health | 2.972 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: Physical Component Summary | 2.650 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: Mental Component Summary | 4.112 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: Physical component Summary | 2.686 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: Mental component Summary | 3.672 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: Physical Function | 1.742 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: Bodily Pain | 3.458 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: General Health | 3.764 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: Role-Physical | 4.626 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 169: Social functioning | 4.471 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: Physical Function | 1.523 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: Role Physical | 4.416 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: Bodily Pain | 3.721 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: General Health | 3.409 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: Vitality | 3.859 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: Social Functioning | 4.771 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: Role-Emotional | 4.834 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in 36-item Short Form Health Survey (SF-36) | Day 85: Mental Health | 2.287 Score on a Scale |
Secondary
Change From Baseline in Components of ESSDAI
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain. The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm. Domain: (Score for activity level) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2) (No = No Disease Activity, Low = Low Disease Activity, Moderate = Moderate Disease Activity, High = High Disease Activity)
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
Population: Modified ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Renal | -0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Constitutional | -0.3 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Haematogical | 0.2 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Lymphadenopathy | -0.8 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Muscular | -0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Glandular | -0.5 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Pulmonary | 0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Articular | -1.3 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Peripheral Nervous System | -0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Cutaneous | -0.4 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Biological | 0.1 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Pulmonary | 0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Haematological | 0.1 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Renal | -0.1 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Articular | -0.4 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Muscular | -0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Biological | -0.1 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Peripheral Nervous System | -0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Constitutional | -0.2 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Haematological | 0.1 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Constitutional | -0.3 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Biological | -0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Glandular | -0.2 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Constitutional | -0.2 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Lymphadenopathy | -0.7 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Lymphadenopathy | -0.6 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Lymphadenopathy | -0.7 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Glandular | -0.5 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Glandular | -0.4 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Articular | -1.2 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Renal | -0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Cutaneous | -0.4 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Pulmonary | -0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Articular | -1.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Renal | -0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Glandular | -0.4 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Muscular | -0.1 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Cutaneous | -0.4 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Peripheral Nervous System | -0.1 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Muscular | -0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Haematological | 0.1 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Pulmonary | 0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Biological | -0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Articular | -0.7 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Constitutional | -0.3 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Renal | -0.1 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Lymphadenopathy | -0.9 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Cutaneous | -0.3 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Glandular | -0.4 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Muscular | -0.1 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Articular | -1.4 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Cutaneous | -0.3 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Cutaneous | -0.3 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Peripheral Nervous System | -0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Pulmonary | -0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Peripheral Nervous System | -0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Renal | -0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Haematological | 0.1 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Muscular | -0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Pulmonary | -0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Peripheral Nervous | -0.1 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Lymphadenopathy | -0.6 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Haematological | 0.1 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Biological | 0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Biological | 0.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Constitutional | -0.3 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Biological | 0.2 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Constitutional | -0.4 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Lymphadenopathy | -0.5 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Glandular | -0.2 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Articular | -0.3 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Cutaneous | -0.2 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Renal | -0.2 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Pulmonary | 0.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Muscular | -0.0 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Peripheral Nervous System | 0.0 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Haematogical | 0.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 29: Biological | 0.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Constitutional | -0.3 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Lymphadenopathy | -0.6 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Glandular | -0.4 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Articular | -0.8 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Cutaneous | -0.2 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Pulmonary | 0.2 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Renal | -0.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Muscular | -0.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Peripheral Nervous System | 0.0 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Haematological | 0.2 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 57: Biological | 0.0 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Constitutional | -0.4 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Lymphadenopathy | -0.8 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Glandular | -0.5 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Articular | -1.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Cutaneous | -0.2 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Pulmonary | 0.2 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Renal | -0.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Muscular | -0.0 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Peripheral Nervous System | 0.0 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Haematological | 0.2 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Cutaneous | -0.5 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 85: Biological | 0.2 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Constitutional | -0.3 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Lymphadenopathy | -0.9 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Glandular | -0.5 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Articular | -1.3 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Cutaneous | -0.4 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Pulmonary | 0.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Renal | 0.0 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Muscular | -0.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Peripheral Nervous System | -0.0 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Haematological | 0.2 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 113: Biological | 0.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Constitutional | -0.4 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Lymphadenopathy | -0.9 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Glandular | -0.6 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Articular | -1.4 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Pulmonary | 0.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Renal | -0.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Muscular | -0.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Peripheral Nervous System | -0.0 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Haematological | 0.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 141: Biological | 0.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Constitutional | -0.4 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Lymphadenopathy | -1.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Glandular | -0.5 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Articular | -1.8 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Cutaneous | -0.5 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Pulmonary | 0.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Renal | 0.0 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Muscular | -0.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Peripheral Nervous | -0.0 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Components of ESSDAI | Day 169: Haematological | 0.3 Score on a Scale |
Secondary
Change From Baseline in ESSPRI Components
The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components. Total Score Range (0 = Best outcome and 10 = Worst Outcome) The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: Modified ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 29: Dryness Score | -0.21 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 29: Fatigue Score | -0.57 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 29: Pain Score | -0.34 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 57: Dryness Score | -0.92 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 57: Fatigue Score | -1.09 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 57: Pain Score | -0.60 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 85: Dryness Score | -0.68 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 85: Fatigue Score | -1.27 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 85: Pain Score | -0.70 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 113: Dryness Score | -0.74 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 113: Fatigue Score | -1.02 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 113: Pain Score | -0.76 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 141: Dryness Score | -0.89 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 141: Fatigue Score | -1.18 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 141: Pain Score | -0.70 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 169: Dryness Score | -0.84 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 169: Fatigue Score | -1.28 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 169: Pain Score | -1.11 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 141: Fatigue Score | -1.73 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 29: Dryness Score | -0.26 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 113: Dryness Score | -1.19 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 29: Fatigue Score | -1.01 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 169: Pain Score | -1.45 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 29: Pain Score | -0.53 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 113: Fatigue Score | -1.76 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 57: Dryness Score | -0.52 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 141: Pain Score | -1.39 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 57: Fatigue Score | -1.22 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 113: Pain Score | -1.37 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 57: Pain Score | -0.90 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 169: Fatigue Score | -1.57 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 85: Dryness Score | -0.91 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 141: Dryness Score | -1.05 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 85: Fatigue Score | -1.56 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 169: Dryness Score | -1.04 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in ESSPRI Components | Day 85: Pain Score | -1.31 Score on a Scale |
Secondary
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI)
The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components. Total Score Range (0 = Best outcome and 10 = Worst Outcome) The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.
Time frame: Day 169
Population: Modified ITT Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI) | -1.26 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI) | -1.52 Score on a Scale |
p-value: 0.3367longitudinal repeated measures analysis
Secondary
Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI)
For the FSFI, is a 19 item instrument used for assessing key dimensions of female sexual function over the past 4 weeks with 6 domains being analyzed. The specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI are scored on a scale ranging from 0 to 5, with higher scores indicating better performance. Domain scores are calculated by summing the scores of the individual questions that make up the domain and multiplying the sum by the factor in the table below. The full scale score is the sum of the six domain scores. Full Scale Score range: 2.0(minimum score) - 36.0 (maximum score) Negative Score = Reduced functioning Positive Score = Improved functioning
Time frame: Day 85, Day 169
Population: Modified ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI) | Day 85 | -2.44 Scores on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI) | Day 169 | -2.32 Scores on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI) | Day 85 | -1.56 Scores on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI) | Day 169 | -1.87 Scores on a Scale |
Secondary
Change From Baseline in Numeric Rating Scale for Eye Dryness
The mean change from baseline in patient symptoms using the Numeric Rating Scale (NRS) for eye dryness at all measured time points up to Day 169. The oral and ocular dryness are each assessed by the patients with numeric rating scales from 0 to 10 with 0 representing no dryness and 10 representing maximal dryness
Time frame: Day 1, 29, 57, 85, 113, 141, 169
Population: Modified ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Eye Dryness | Day 85 | -0.9 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Eye Dryness | Day 29 | -0.4 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Eye Dryness | Day 57 | -0.9 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Eye Dryness | Day 113 | -1.0 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Eye Dryness | Day 141 | -0.8 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Eye Dryness | Day 169 | -0.9 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Eye Dryness | Day 141 | -1.0 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Eye Dryness | Day 113 | -1.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Eye Dryness | Day 29 | -0.3 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Eye Dryness | Day 169 | -1.0 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Eye Dryness | Day 57 | -0.6 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Eye Dryness | Day 85 | -0.8 Score on a Scale |
Secondary
Change From Baseline in Numeric Rating Scale for Mouth Dryness
The mean change from baseline in participant symptoms using the Numeric Rating Scale (NRS) for mouth dryness at all measured time points up to Day 169. The oral and ocular dryness are each assessed by the patients with numeric rating scales from 0 to 10 with 0 representing no dryness and 10 representing maximal dryness
Time frame: Day 1, 29, 57, 85, 113, 141, 169
Population: Modified ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Mouth Dryness | Day 29 | -0.8 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Mouth Dryness | Day 57 | -1.3 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Mouth Dryness | Day 85 | -1.3 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Mouth Dryness | Day 113 | -1.2 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Mouth Dryness | Day 141 | -1.3 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Mouth Dryness | Day 169 | -1.3 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Mouth Dryness | Day 141 | -1.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Mouth Dryness | Day 29 | -0.5 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Mouth Dryness | Day 113 | -1.3 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Mouth Dryness | Day 57 | -0.9 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Mouth Dryness | Day 169 | -1.2 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Numeric Rating Scale for Mouth Dryness | Day 85 | -1.1 Score on a Scale |
Secondary
Change From Baseline in Participant Assessment of Disease Activity
The participant global assessment of disease activity are assessed with visual analog scales. The participant marks a vertical line through a horizontal line, where the beginning of the horizontal line represents the best situation, and the end of the horizontal line represents the very worst situation. The CRF collects the distance in millimeters from the start of the scale that is marked as well as the length of the scale in millimeters. In cases that the length of the scale is in less or more than 100 millimeters, then the participants measurement will be rescaled to the equivalent of 100 millimeters using the formula below: Rescale Measurement in mm = (measurement as reported on CRF in mm/length of the line on CRF in mm) \* 100mm A negative score = participant assessment of disease activity has improved A positive score = participant assessment of disease activity has worsened
Time frame: Day 29, 57, 85, 113, 141, 169
Population: Modified ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in Participant Assessment of Disease Activity | Day 169 | -10.1 Score on VAS 0-100mm scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Participant Assessment of Disease Activity | Day 29 | -4.0 Score on VAS 0-100mm scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Participant Assessment of Disease Activity | Day 57 | -7.5 Score on VAS 0-100mm scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Participant Assessment of Disease Activity | Day 85 | -10.4 Score on VAS 0-100mm scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Participant Assessment of Disease Activity | Day 113 | -8.0 Score on VAS 0-100mm scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Participant Assessment of Disease Activity | Day 141 | -5.1 Score on VAS 0-100mm scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Participant Assessment of Disease Activity | Day 113 | -9.7 Score on VAS 0-100mm scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Participant Assessment of Disease Activity | Day 169 | -9.0 Score on VAS 0-100mm scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Participant Assessment of Disease Activity | Day 85 | -10.2 Score on VAS 0-100mm scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Participant Assessment of Disease Activity | Day 29 | -7.1 Score on VAS 0-100mm scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Participant Assessment of Disease Activity | Day 141 | -11.0 Score on VAS 0-100mm scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Participant Assessment of Disease Activity | Day 57 | -6.3 Score on VAS 0-100mm scale |
Secondary
Change From Baseline in Patient Fatigue
The mean change from baseline in patient fatigue using Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue assessment of disease activity at all measured time points up to Day 169. PROMIS Fatigue instruments 10 Questions ranging from a score 0 to 40. Sum of the values gives you the raw sum. The raw is inputted into this formula to give you the raw score: Raw Score = (Raw sum\*number of items on the short form)/(Number of items that were actually answered) Raw score is translated to a T-Score using a table. T-Score is used as the final score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. The standardized T-score is reported as the final score for each participant. A negative T Score = Better Prognosis A positive T Score = Worse prognosis
Time frame: Day 29, 57, 85, 113, 141, 169
Population: Modified ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in Patient Fatigue | Day 85 | -4.85 T-Score |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Patient Fatigue | Day 113 | -4.17 T-Score |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Patient Fatigue | Day 57 | -4.12 T-Score |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Patient Fatigue | Day 141 | -4.84 T-Score |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Patient Fatigue | Day 169 | -5.56 T-Score |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Patient Fatigue | Day 29 | -3.08 T-Score |
| Placebo - Double Blind Treatment Period | Change From Baseline in Patient Fatigue | Day 169 | -5.59 T-Score |
| Placebo - Double Blind Treatment Period | Change From Baseline in Patient Fatigue | Day 57 | -4.02 T-Score |
| Placebo - Double Blind Treatment Period | Change From Baseline in Patient Fatigue | Day 29 | -3.99 T-Score |
| Placebo - Double Blind Treatment Period | Change From Baseline in Patient Fatigue | Day 85 | -5.48 T-Score |
| Placebo - Double Blind Treatment Period | Change From Baseline in Patient Fatigue | Day 113 | -5.32 T-Score |
| Placebo - Double Blind Treatment Period | Change From Baseline in Patient Fatigue | Day 141 | -5.68 T-Score |
Secondary
Change From Baseline in Physician Global Assessment of Disease Activity
The physician global assessment of disease activity are assessed with visual analog scales. The physician marks a vertical line through a horizontal line, where the beginning of the horizontal line represents the best situation, and the end of the horizontal line represents the very worst situation. The CRF collects the distance in millimeters from the start of the scale that is marked as well as the length of the scale in millimeters. In cases that the length of the scale is in less or more than 100 millimeters, then the participants measurement will be rescaled to the equivalent of 100 millimeters using the formula below: Rescale Measurement in mm = (measurement as reported on CRF in mm/length of the line on CRF in mm) \* 100mm A negative score = physician assessment of disease activity has improved A positive score = physician assessment of disease activity has worsened
Time frame: Day 29, 57, 85, 113, 141, 169
Population: Modified ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in Physician Global Assessment of Disease Activity | Day 29 | -10.3 Score on VAS 0-100mm Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Physician Global Assessment of Disease Activity | Day 57 | -16.2 Score on VAS 0-100mm Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Physician Global Assessment of Disease Activity | Day 85 | -20.8 Score on VAS 0-100mm Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Physician Global Assessment of Disease Activity | Day 113 | -22.8 Score on VAS 0-100mm Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Physician Global Assessment of Disease Activity | Day 141 | -23.7 Score on VAS 0-100mm Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Physician Global Assessment of Disease Activity | Day 169 | -23.0 Score on VAS 0-100mm Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Physician Global Assessment of Disease Activity | Day 141 | -21.7 Score on VAS 0-100mm Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Physician Global Assessment of Disease Activity | Day 29 | -10.5 Score on VAS 0-100mm Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Physician Global Assessment of Disease Activity | Day 113 | -19.8 Score on VAS 0-100mm Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Physician Global Assessment of Disease Activity | Day 57 | -16.7 Score on VAS 0-100mm Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Physician Global Assessment of Disease Activity | Day 169 | -23.7 Score on VAS 0-100mm Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in Physician Global Assessment of Disease Activity | Day 85 | -19.4 Score on VAS 0-100mm Scale |
Secondary
Change From Baseline in Schirmer's Test
The Mean change from baseline in Schirmer's Test at all measured time points up to day 169 The length in millimeters that the strip wets during the 5 minute test period for each eye. Collection is done separately for each eye.
Time frame: Day 85, Day 169
Population: Modified ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in Schirmer's Test | Day 85: Study Eye | 1.9 millimeters |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Schirmer's Test | Day 85: Non-Study Eye | 0.1 millimeters |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Schirmer's Test | Day 85: Average of Both Eyes | 1.10 millimeters |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Schirmer's Test | Day 169: Study Eye | 1.7 millimeters |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Schirmer's Test | Day 169: Non-Study Eye | 0.6 millimeters |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Schirmer's Test | Day 169: Average of Both Eyes | 1.21 millimeters |
| Placebo - Double Blind Treatment Period | Change From Baseline in Schirmer's Test | Day 169: Non-Study Eye | 0.2 millimeters |
| Placebo - Double Blind Treatment Period | Change From Baseline in Schirmer's Test | Day 85: Study Eye | 1.5 millimeters |
| Placebo - Double Blind Treatment Period | Change From Baseline in Schirmer's Test | Day 169: Study Eye | 1.0 millimeters |
| Placebo - Double Blind Treatment Period | Change From Baseline in Schirmer's Test | Day 85: Non-Study Eye | 0.8 millimeters |
| Placebo - Double Blind Treatment Period | Change From Baseline in Schirmer's Test | Day 169: Average of Both Eyes | 0.82 millimeters |
| Placebo - Double Blind Treatment Period | Change From Baseline in Schirmer's Test | Day 85: Average of Both Eyes | 1.41 millimeters |
Secondary
Change From Baseline in Stimulated Salivary Flow
The mean change from baseline in Stimulated whole salivary flow at all measured time points up to Day 169.
Time frame: Day 85, Day 169
Population: Modified ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in Stimulated Salivary Flow | Day 85 | 0.11 mL/min |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Stimulated Salivary Flow | Day 169 | 0.056 mL/min |
| Placebo - Double Blind Treatment Period | Change From Baseline in Stimulated Salivary Flow | Day 85 | 0.169 mL/min |
| Placebo - Double Blind Treatment Period | Change From Baseline in Stimulated Salivary Flow | Day 169 | 0.108 mL/min |
Secondary
Change From Baseline in Tear Break-up Time
The Mean change from baseline in Tear Break-up Time at all measured time points up to day 169 The CRF collects the time in seconds to first appearance of a random dry spot on the corneal surface for 3 repetitions in each eye. The average time will calculated for each eye averaging the 3 measurements for each eye separately. In case only 2 measurements are available, the average of the 2 measurements will be calculated. In case there is only 1 measurement, that measurement will be used for the analysis.
Time frame: Day 85, Day 169
Population: Modified ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in Tear Break-up Time | Day 85: Non-Study Eye | -0.70 Seconds |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Tear Break-up Time | Day 85: Study Eye | -0.13 Seconds |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Tear Break-up Time | Day 85: Average of Both Eyes | -0.41 Seconds |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Tear Break-up Time | Day 169: Study Eye | -0.23 Seconds |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Tear Break-up Time | Day 169: Non-Study Eye | -0.79 Seconds |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Tear Break-up Time | Day 169: Average of Both Eyes | -0.50 Seconds |
| Placebo - Double Blind Treatment Period | Change From Baseline in Tear Break-up Time | Day 169: Non-Study Eye | -0.62 Seconds |
| Placebo - Double Blind Treatment Period | Change From Baseline in Tear Break-up Time | Day 169: Study Eye | -0.32 Seconds |
| Placebo - Double Blind Treatment Period | Change From Baseline in Tear Break-up Time | Day 85: Study Eye | 0.18 Seconds |
| Placebo - Double Blind Treatment Period | Change From Baseline in Tear Break-up Time | Day 85: Non-Study Eye | -0.12 Seconds |
| Placebo - Double Blind Treatment Period | Change From Baseline in Tear Break-up Time | Day 169: Average of Both Eyes | -0.43 Seconds |
| Placebo - Double Blind Treatment Period | Change From Baseline in Tear Break-up Time | Day 85: Average of Both Eyes | 0.09 Seconds |
Secondary
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population
The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP. Assesment of Disease Activity: 0-100 scale \[100=Most severe\] Positive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: Modified intent to treat (ITT)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population | Day 141 - Assessment of Disease Activity | -11.0 Scores on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population | Day 29 - Assessment of Disease Activity | -7.1 Scores on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population | Day 113 - Assessment of Disease Activity | -9.7 Scores on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population | Day 57 - Assessment of Disease Activity | -6.3 Scores on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population | Day 169 - Assessment of Disease Activity | -9.0 Scores on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population | Day 85 - Assessment of Disease Activity | -10.2 Scores on a Scale |
Secondary
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3
The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP. Assesment of Disease Activity: 0-100 scale \[100=Most severe\] Positive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of Less than 3
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Placebo - Double Blind Treatment Period | 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 | -15.3 Scores on a Scale |
| Placebo - Double Blind Treatment Period | 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 | -11.8 Scores on a Scale |
| Placebo - Double Blind Treatment Period | 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 | -11.1 Scores on a Scale |
| Placebo - Double Blind Treatment Period | 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 | -4.8 Scores on a Scale |
| Placebo - Double Blind Treatment Period | 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 | -10.9 Scores on a Scale |
| Placebo - Double Blind Treatment Period | 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 | -13.5 Scores on a Scale |
Secondary
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3
The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP. Assesment of Disease Activity: 0-100 scale \[100=Most severe\] Positive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of at least 3
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Placebo - Double Blind Treatment Period | 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 | -8.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | 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 | -3.5 Score on a Scale |
| Placebo - Double Blind Treatment Period | 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 | -9.1 Score on a Scale |
| Placebo - Double Blind Treatment Period | 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 | -6.5 Score on a Scale |
| Placebo - Double Blind Treatment Period | 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 | -7.8 Score on a Scale |
| Placebo - Double Blind Treatment Period | 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 | -7.7 Score on a Scale |
Secondary
Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population
The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP. CRP: measured lab value Positive Number = Increased level of CRP Negative Number = Reduced Level of CRP
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: Modified intent to treat (ITT)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population | Day 29 - CRP | 0.3 mg/L |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population | Day 57 - CRP | -0.1 mg/L |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population | Day 85 - CRP | -0.2 mg/L |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population | Day 113 - CRP | 1.6 mg/L |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population | Day 141 - CRP | 3.5 mg/L |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population | Day 169 - CRP | -0.2 mg/L |
| Placebo - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population | Day 141 - CRP | -0.2 mg/L |
| Placebo - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population | Day 29 - CRP | 0.6 mg/L |
| Placebo - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population | Day 113 - CRP | 0.3 mg/L |
| Placebo - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population | Day 57 - CRP | 1.8 mg/L |
| Placebo - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population | Day 169 - CRP | 0.0 mg/L |
| Placebo - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population | Day 85 - CRP | 3.0 mg/L |
Secondary
Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3
The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP. CRP: measured lab value Positive Number = Increased level of CRP Negative Number = Reduced Level of CRP
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of Less than 3
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 29 - CRP | 2.1 mg/L |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 57 - CRP | 0.5 mg/L |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 85 - CRP | 1.4 mg/L |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 113 - CRP | 1.3 mg/L |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 141 - CRP | 0.7 mg/L |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 169 - CRP | 0.2 mg/L |
| Placebo - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 141 - CRP | 0.8 mg/L |
| Placebo - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 29 - CRP | 1.8 mg/L |
| Placebo - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 113 - CRP | 0.1 mg/L |
| Placebo - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 57 - CRP | 1.0 mg/L |
| Placebo - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 169 - CRP | 0.2 mg/L |
| Placebo - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 85 - CRP | 0.1 mg/L |
Secondary
Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3
The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP. CRP: measured lab value Positive Number = Increased level of CRP Negative Number = Reduced Level of CRP
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of at least 3
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 113 - CRP | 1.2 mg/L |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 29 - CRP | -1.5 mg/L |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 141 - CRP | 4.5 mg/L |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 85 - CRP | -2.2 mg/L |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 169 - CRP | -1.4 mg/L |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 57 - CRP | -1.3 mg/L |
| Placebo - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 169 - CRP | -0.7 mg/L |
| Placebo - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 57 - CRP | 1.3 mg/L |
| Placebo - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 85 - CRP | 3.8 mg/L |
| Placebo - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 113 - CRP | -0.4 mg/L |
| Placebo - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 141 - CRP | -1.4 mg/L |
| Placebo - Double Blind Treatment Period | Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 29 - CRP | -0.7 mg/L |
Secondary
Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population
The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP. Tender Joint: Count 1-28 Swollen Joint: Count 1-28 Negative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: Modified intent to treat (ITT)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 29 - Tender Joint | -1.7 Joint Count |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 29 - Swollen Joint | -0.5 Joint Count |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 57 - Tender Joint | -2.6 Joint Count |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 57 - Swollen Joint | -1.0 Joint Count |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 85 - Tender Joint | -2.9 Joint Count |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 85 - Swollen Joint | -1.4 Joint Count |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 113 - Tender Joint | -3.1 Joint Count |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 113 - Swollen Joint | -1.5 Joint Count |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 141 - Tender Joint | -3.6 Joint Count |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 141 - Swollen Joint | -1.4 Joint Count |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 169 - Tender Joint | -2.9 Joint Count |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 169 - Swollen Joint | -1.4 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 169 - Tender Joint | -4.4 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 29 - Tender Joint | -1.9 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 113 - Tender Joint | -3.9 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 29 - Swollen Joint | -0.6 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 141 - Swollen Joint | -1.8 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 57 - Tender Joint | -2.9 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 113 - Swollen Joint | -1.9 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 57 - Swollen Joint | -1.0 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 169 - Swollen Joint | -2.0 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 85 - Tender Joint | -3.4 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 141 - Tender Joint | -4.1 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population | Day 85 - Swollen Joint | -1.4 Joint Count |
Secondary
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3
The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP. Tender Joint: Count 1-28 Swollen Joint: Count 1-28 Negative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of Less than 3
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 169 - Tender Joint | -0.7 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 29 - Tender Joint | -0.2 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 113 - Tender Joint | -0.5 Joint Count |
| Placebo - Double Blind Treatment Period | 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 |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 141 - Swollen Joint | 0.3 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 57 - Tender Joint | 0.1 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 113 - Swollen Joint | 0.1 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 57 - Swollen Joint | 0.0 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 169 - Swollen Joint | -0.0 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 85 - Tender Joint | 0.1 Joint Count |
| Placebo - Double Blind Treatment Period | 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 |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 | Day 85 - Swollen Joint | 0.1 Joint Count |
Secondary
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3
The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP. Tender Joint: Count 1-28 Swollen Joint: Count 1-28 Negative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of at least 3
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Abatacept - Double Blind Treatment Period | 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 |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 169 - Tender Joint | -6.7 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 29 - Tender Joint | -3.0 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 113 - Tender Joint | -6.0 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 29 - Swollen Joint | -0.9 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 141 - Swollen Joint | -3.0 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 57 - Tender Joint | -4.8 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 113 - Swollen Joint | -2.9 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 57 - Swollen Joint | -1.6 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 169 - Swollen Joint | -3.1 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 85 - Tender Joint | -5.4 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 141 - Tender Joint | -6.4 Joint Count |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 | Day 85 - Swollen Joint | -2.2 Joint Count |
Secondary
Change From Baseline in the Ocular Staining Score (OSS)
The Mean change from baseline in OSS at all measured time points up to day 169 Score of 0 = No Staining Score of 12 = diffuse staining The total score will be calculated as the sum of the score for these parameters for each eye. Medial Nasal Bulbar Conjunctiva (MNBC) \[score scale: 0 - 3\], Corneal (CORN) Staining of Punctate Epithelial Erosions (PEE) \[score scale: 0 - 3\], Lateral Temporal Bulbar Conjunctiva (LTBC) \[score scale: 0 - 3\], Patches of Confluent Staining (CONF) \[score scale: 0 - 1\], PEE observed in the pupil region, i.e. central 4mm diameter portion of the cornea (PUPL) \[score scale: 0 - 1\], one of more filaments seen anywhere on the cornea (FILA) \[score scale: 0 - 1\]
Time frame: Day 85, Day 169
Population: Modified ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Ocular Staining Score (OSS) | Day 85: Study Eye | -1.7 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Ocular Staining Score (OSS) | Day 85: Non-Study Eye | -0.6 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Ocular Staining Score (OSS) | Day 85: Average of Both Eyes | -1.15 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Ocular Staining Score (OSS) | Day 169: Study Eye | -1.5 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Ocular Staining Score (OSS) | Day 169: Non-Study Eye | -0.5 Score on a Scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Ocular Staining Score (OSS) | Day 169: Average of Both Eyes | -0.99 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Ocular Staining Score (OSS) | Day 169: Non-Study Eye | 0.3 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Ocular Staining Score (OSS) | Day 85: Study Eye | -0.5 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Ocular Staining Score (OSS) | Day 169: Study Eye | -0.7 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Ocular Staining Score (OSS) | Day 85: Non-Study Eye | 0.4 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Ocular Staining Score (OSS) | Day 169: Average of Both Eyes | -0.19 Score on a Scale |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Ocular Staining Score (OSS) | Day 85: Average of Both Eyes | -0.06 Score on a Scale |
Secondary
Change From Baseline in the Stimulated Whole Salivary Flow
The mean change from baseline in the stimulated whole salivary flow at Day 169
Time frame: Day 169
Population: Modified ITT Population with Stimulated Whole Salivary Flow of at Least 0.1 mL/min at Both Screening and Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in the Stimulated Whole Salivary Flow | 0.057 mL/min |
| Placebo - Double Blind Treatment Period | Change From Baseline in the Stimulated Whole Salivary Flow | 0.108 mL/min |
p-value: 0.5841longitudinal repeated measures analysis
Secondary
Change From Baseline in Unstimulated Salivary Flow
The mean change from baseline in unstimulated whole salivary flow at all measured time points up to Day 169.
Time frame: Day 85, Day 169
Population: Modified ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline in Unstimulated Salivary Flow | Day 85 | 0.106 mL/min |
| Abatacept - Double Blind Treatment Period | Change From Baseline in Unstimulated Salivary Flow | Day 169 | 0.051 mL/min |
| Placebo - Double Blind Treatment Period | Change From Baseline in Unstimulated Salivary Flow | Day 85 | 0.158 mL/min |
| Placebo - Double Blind Treatment Period | Change From Baseline in Unstimulated Salivary Flow | Day 169 | 0.105 mL/min |
Secondary
Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full 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
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: Modified ITT Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population | Day 113 | -0.8 Scores on a scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population | Day 57 | -0.6 Scores on a scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population | Day 141 | -0.8 Scores on a scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population | Day 29 | -0.4 Scores on a scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population | Day 169 | -0.9 Scores on a scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population | Day 85 | -0.8 Scores on a scale |
| Placebo - Double Blind Treatment Period | Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population | Day 169 | -1.1 Scores on a scale |
| Placebo - Double Blind Treatment Period | Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population | Day 29 | -0.4 Scores on a scale |
| Placebo - Double Blind Treatment Period | Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population | Day 57 | -0.7 Scores on a scale |
| Placebo - Double Blind Treatment Period | Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population | Day 113 | -1.0 Scores on a scale |
| Placebo - Double Blind Treatment Period | Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population | Day 141 | -1.0 Scores on a scale |
| Placebo - Double Blind Treatment Period | Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population | Day 85 | -0.8 Scores on a scale |
Secondary
Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3
The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP = 0.56 \* sqrt(tender28) + 0.28 \* sqrt(swollen28) + 0.36 \* ln(hsCRP+1) + 0.014 \* VAS + 0.96. (sqrt = Square root, ln = natural log) Positive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: Modified ITT Population with Baseline Tender plus Swollen Joint Count of at Least 3
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 | Day 29 | -0.5 Scores on a scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 | Day 57 | -0.9 Scores on a scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 | Day 85 | -1.1 Scores on a scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 | Day 113 | -1.1 Scores on a scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 | Day 141 | -1.2 Scores on a scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 | Day 169 | -1.3 Scores on a scale |
| Placebo - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 | Day 141 | -1.5 Scores on a scale |
| Placebo - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 | Day 29 | -0.6 Scores on a scale |
| Placebo - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 | Day 113 | -1.4 Scores on a scale |
| Placebo - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 | Day 57 | -1.0 Scores on a scale |
| Placebo - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 | Day 169 | -1.5 Scores on a scale |
| Placebo - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 | Day 85 | -1.2 Scores on a scale |
Secondary
Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3
The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm. DAS28-CRP = 0.56 \* sqrt(tender28) + 0.28 \* sqrt(swollen28) + 0.36 \* ln(hsCRP+1) + 0.014 \* VAS + 0.96. (sqrt = Square root, ln = natural log) Positive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: Modified ITT Population with Baseline Tender plus Swollen Joint Count of Less than 3
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 | Day 29 | -0.3 Scores on a scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 | Day 57 | -0.2 Scores on a scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 | Day 85 | -0.4 Scores on a scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 | Day 113 | -0.3 Scores on a scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 | Day 141 | -0.2 Scores on a scale |
| Abatacept - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 | Day 169 | -0.3 Scores on a scale |
| Placebo - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 | Day 141 | -0.4 Scores on a scale |
| Placebo - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 | Day 29 | -0.2 Scores on a scale |
| Placebo - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 | Day 113 | -0.3 Scores on a scale |
| Placebo - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 | Day 57 | -0.2 Scores on a scale |
| Placebo - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 | Day 169 | -0.5 Scores on a scale |
| Placebo - Double Blind Treatment Period | Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 | Day 85 | -0.4 Scores on a scale |
Secondary
Geometric Mean of Trough Concentration (Cmin) of Abatacept
Geometric mean of trough concentration (Cmin) of abatacept at all measured time points.
Time frame: Day 29, 85, 113, 141, 169
Population: Pharmacokinetic (PK) Evaluable Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Geometric Mean of Trough Concentration (Cmin) of Abatacept | Day 113 | 25.567 µg/mL | Geometric Coefficient of Variation 42.1 |
| Abatacept - Double Blind Treatment Period | Geometric Mean of Trough Concentration (Cmin) of Abatacept | Day 29 | 21.401 µg/mL | Geometric Coefficient of Variation 36 |
| Abatacept - Double Blind Treatment Period | Geometric Mean of Trough Concentration (Cmin) of Abatacept | Day 85 | 27.543 µg/mL | Geometric Coefficient of Variation 38.4 |
| Abatacept - Double Blind Treatment Period | Geometric Mean of Trough Concentration (Cmin) of Abatacept | Day 141 | 25.870 µg/mL | Geometric Coefficient of Variation 40.8 |
| Abatacept - Double Blind Treatment Period | Geometric Mean of Trough Concentration (Cmin) of Abatacept | Day 169 | 24.522 µg/mL | Geometric Coefficient of Variation 42.7 |
Secondary
Laboratory Marked Abnormalities: Cumulative Abatacept Period
Laboratory values meeting the marked abnormality criteria
Time frame: Day 365 and 3 months of follow up approximately 450 Days
Population: Cumulative Abatacept Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Eosinophils High | 5.6 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Eosinophils Low | NA Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | lymphocytes high | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Glucose, Urine High | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Glucose, Urine Low | NA Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Protein, Urine High | 5.6 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | WBC, Urine High | 100.0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Hematocrit High | NA Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Hematocrit Low | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Hemoglobin High | NA Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Hemoglobin Low | 0.6 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Platelet count High | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Platelet count low | 0.6 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Leukocytes high | 0.6 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Leukocytes low | 18.6 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Basophils high | 0.6 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Basophils Low | NA Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | lymphocytes low | 12.4 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Monocytes high | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Monocytes Low | NA Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Neutrophils+Bands High | NA Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Neutrophils+Bands Low | 7.3 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Alanine Aminotransferase High | 1.7 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Alkaline Phosphatase HIgh | 0.6 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Aspartate Aminotransferase High | 1.1 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Bilirubin, Total High | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | G-Glutamyl Transferase High | 5.6 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Blood Urea Nitrogen High | 1.7 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Creatinine High | 0.6 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Calcium High | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Calcium Low | 1.1 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Chloride High | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Chloride Low | 1.1 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Phosphorus High | 0.6 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Phosphorus Low | 1.1 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Potassium High | 0.6 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Potassium Low | 0.6 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Sodium High | 0.6 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Sodium Low | 1.7 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Glucose, Serum High | 0.6 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Glucose, Serum Low | 5.1 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Albumin High | NA Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Albumin Low | 1.7 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Protein, Total High | 4.0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Protein, Total Low | 0.6 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Creatine Kinase High | 2.3 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Blood, Urine High | 14.7 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Cumulative Abatacept Period | Blood, Urine Low | NA Percentage |
Secondary
Laboratory Marked Abnormalities: Double Blind Period
Laboratory values meeting the marked abnormality criteria
Time frame: Day 1 up to first dose of OL abatacept or up to 56 post last dose in double -blind for those not in OL.
Population: As-Treated Analysis Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Leukocytes low | 12.1 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Potassium Low | 1.1 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Basophils high | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Blood, Urine Low | NA Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Basophils Low | NA Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Albumin High | NA Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Eosinophils High | 4.4 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Glucose, Urine High | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Eosinophils Low | NA Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Sodium Low | 2.2 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | lymphocytes high | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Glucose, Urine Low | NA Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | lymphocytes low | 9.9 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Albumin Low | 2.2 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Monocytes high | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Protein, Urine High | 2.2 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Monocytes Low | NA Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Potassium High | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Neutrophils+Bands High | NA Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Hematocrit High | NA Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Neutrophils+Bands Low | 6.6 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Protein, Total High | 2.2 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Alanine Aminotransferase High | 1.1 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Hematocrit Low | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Alkaline Phosphatase HIgh | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Glucose, Serum High | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Aspartate Aminotransferase High | 1.1 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Hemoglobin High | NA Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Bilirubin, Total High | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Protein, Total Low | 1.1 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | G-Glutamyl Transferase High | 6.6 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Hemoglobin Low | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Blood Urea Nitrogen High | 1.1 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Sodium High | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Creatinine High | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Platelet count High | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Calcium High | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Creatine Kinase High | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Calcium Low | 1.1 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Platelet count low | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Chloride High | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Glucose, Serum Low | 2.2 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Chloride Low | 1.1 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Leukocytes high | 1.1 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Phosphorus High | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Blood, Urine High | 14.3 Percentage |
| Abatacept - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Phosphorus Low | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | lymphocytes high | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Potassium High | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Potassium Low | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Sodium High | 1.1 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Sodium Low | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Glucose, Serum High | 1.1 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Glucose, Serum Low | 5.3 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Albumin High | NA Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Albumin Low | 1.1 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Protein, Total High | 3.2 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Protein, Total Low | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Creatine Kinase High | 4.2 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Blood, Urine High | 9.5 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Blood, Urine Low | NA Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Glucose, Urine High | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Glucose, Urine Low | NA Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Protein, Urine High | 3.2 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Hematocrit High | NA Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Hematocrit Low | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Hemoglobin High | NA Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Hemoglobin Low | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Platelet count High | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Platelet count low | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Leukocytes high | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Leukocytes low | 8.4 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Basophils high | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Basophils Low | NA Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Eosinophils High | 1.1 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Eosinophils Low | NA Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Phosphorus Low | 1.1 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | lymphocytes low | 14.7 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Monocytes high | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Monocytes Low | NA Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Neutrophils+Bands High | NA Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Neutrophils+Bands Low | 1.1 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Alanine Aminotransferase High | 2.1 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Alkaline Phosphatase HIgh | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Aspartate Aminotransferase High | 3.2 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Bilirubin, Total High | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | G-Glutamyl Transferase High | 1.1 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Blood Urea Nitrogen High | 1.1 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Creatinine High | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Calcium High | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Calcium Low | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Chloride High | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Chloride Low | 0 Percentage |
| Placebo - Double Blind Treatment Period | Laboratory Marked Abnormalities: Double Blind Period | Phosphorus High | 0 Percentage |
Secondary
Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points
Proportion of participants who achieve a minimally clinically important change (of at least 3 points) in the ESSDAI at all measured time points up to Day 169.
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: Modified intent to treat (ITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points | Day 29 | 37 Percentage |
| Abatacept - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points | Day 57 | 37 Percentage |
| Abatacept - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points | Day 85 | 48.9 Percentage |
| Abatacept - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points | Day 113 | 55.4 Percentage |
| Abatacept - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points | Day 141 | 51.1 Percentage |
| Abatacept - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points | Day 169 | 55.4 Percentage |
| Placebo - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points | Day 141 | 56.8 Percentage |
| Placebo - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points | Day 29 | 34.7 Percentage |
| Placebo - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points | Day 113 | 50.5 Percentage |
| Placebo - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points | Day 57 | 44.2 Percentage |
| Placebo - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points | Day 169 | 57.9 Percentage |
| Placebo - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points | Day 85 | 50.5 Percentage |
Secondary
Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points
Proportion of participants who achieve a minimally clinically important change (of at least 5 points) in the ESSDAI at all measured time points up to Day 169.
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: Modified intent to treat (ITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points | Day 29 | 19.6 Percentage |
| Abatacept - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points | Day 57 | 26.1 Percentage |
| Abatacept - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points | Day 85 | 34.8 Percentage |
| Abatacept - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points | Day 113 | 37.0 Percentage |
| Abatacept - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points | Day 141 | 37.0 Percentage |
| Abatacept - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points | Day 169 | 35.9 Percentage |
| Placebo - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points | Day 141 | 36.8 Percentage |
| Placebo - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points | Day 29 | 13.7 Percentage |
| Placebo - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points | Day 113 | 36.8 Percentage |
| Placebo - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points | Day 57 | 24.2 Percentage |
| Placebo - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points | Day 169 | 46.3 Percentage |
| Placebo - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points | Day 85 | 32.6 Percentage |
Secondary
Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point
Proportion of participants who achieve a minimally clinically important change (of at least 1 point) in the ESSPRI at all measured time points up to Day 169.
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Population: Modified intent to treat (ITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point | Day 29 | 31.5 Percentage |
| Abatacept - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point | Day 57 | 42.4 Percentage |
| Abatacept - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point | Day 85 | 44.6 Percentage |
| Abatacept - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point | Day 113 | 42.4 Percentage |
| Abatacept - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point | Day 141 | 40.2 Percentage |
| Abatacept - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point | Day 169 | 41.3 Percentage |
| Placebo - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point | Day 141 | 54.7 Percentage |
| Placebo - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point | Day 29 | 38.9 Percentage |
| Placebo - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point | Day 113 | 52.6 Percentage |
| Placebo - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point | Day 57 | 47.4 Percentage |
| Placebo - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point | Day 169 | 52.6 Percentage |
| Placebo - Double Blind Treatment Period | Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point | Day 85 | 55.8 Percentage |
Secondary
Percentage of Participants With a Positive Antibody Response
Percentage of participants with at least one positive immunogenicity response up to Day 169 and during 3 months follow up (for participants who discontinue during the 6-months double-blind).
Time frame: Day 85 db, day 169 db, post treatment day 85
Population: Immunogenicity Analysis Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Percentage of Participants With a Positive Antibody Response | Study Day 169 | 1.2 Percentage |
| Abatacept - Double Blind Treatment Period | Percentage of Participants With a Positive Antibody Response | Post Treatment Day 85 (DB) | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Percentage of Participants With a Positive Antibody Response | Post Treatment Day 169 (DB) | 0 Percentage |
Secondary
Percentage of Participants With a Positive Antibody Response in the Cumulative Abatacept Period
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.
Time frame: Day 365, post open label treatment day 85
Population: Immunogenicity Analysis Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Percentage of Participants With a Positive Antibody Response in the Cumulative Abatacept Period | Study Day 365 | 2.1 Percentage |
| Abatacept - Double Blind Treatment Period | Percentage of Participants With a Positive Antibody Response in the Cumulative Abatacept Period | Post Treatment Day 85 (OL) | 43.2 Percentage |
Secondary
Summary of Adverse Events: Cumulative Abatacept Period
Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation
Time frame: Day 365 and 3 months of follow up approximately 450 Days
Population: Cumulative Abatacept Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Summary of Adverse Events: Cumulative Abatacept Period | Adverse Events (AEs) | 78.7 Percentage |
| Abatacept - Double Blind Treatment Period | Summary of Adverse Events: Cumulative Abatacept Period | Deaths | 0.6 Percentage |
| Abatacept - Double Blind Treatment Period | Summary of Adverse Events: Cumulative Abatacept Period | Serious Adverse Events (SAEs) | 14.6 Percentage |
| Abatacept - Double Blind Treatment Period | Summary of Adverse Events: Cumulative Abatacept Period | Discontinuation due to AEs | 5.6 Percentage |
| Abatacept - Double Blind Treatment Period | Summary of Adverse Events: Cumulative Abatacept Period | Related Serious Adverse Events | 3.4 Percentage |
| Abatacept - Double Blind Treatment Period | Summary of Adverse Events: Cumulative Abatacept Period | Discontinued due to SAEs | 3.4 Percentage |
| Abatacept - Double Blind Treatment Period | Summary of Adverse Events: Cumulative Abatacept Period | Related AEs | 40.4 Percentage |
Secondary
Summary of Adverse Events: Double Blind Period
Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation
Time frame: Day 1 up to first dose of Open Label Treatment Period (OLTP) abatacept or up to 56 post last dose in double -blind for those not in OL.
Population: As-Treated Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abatacept - Double Blind Treatment Period | Summary of Adverse Events: Double Blind Period | Adverse Events (AEs) | 85.9 Percentage |
| Abatacept - Double Blind Treatment Period | Summary of Adverse Events: Double Blind Period | Deaths | 0 Percentage |
| Abatacept - Double Blind Treatment Period | Summary of Adverse Events: Double Blind Period | Serious Adverse Events | 9.8 Percentage |
| Abatacept - Double Blind Treatment Period | Summary of Adverse Events: Double Blind Period | Discontinuation due to AEs | 3.3 Percentage |
| Placebo - Double Blind Treatment Period | Summary of Adverse Events: Double Blind Period | Discontinuation due to AEs | 2.1 Percentage |
| Placebo - Double Blind Treatment Period | Summary of Adverse Events: Double Blind Period | Adverse Events (AEs) | 71.6 Percentage |
| Placebo - Double Blind Treatment Period | Summary of Adverse Events: Double Blind Period | Serious Adverse Events | 3.2 Percentage |
| Placebo - Double Blind Treatment Period | Summary of Adverse Events: Double Blind Period | Deaths | 1.1 Percentage |