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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02915159




Registration number
NCT02915159
Ethics application status
Date submitted
23/09/2016
Date registered
26/09/2016
Date last updated
10/08/2020

Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome
Scientific title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Primary Sjögrens Syndrome
Secondary ID [1] 0 0
2016-001948-19
Secondary ID [2] 0 0
IM101-603
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sjogrens Disease 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Abatacept
Other interventions - Placebo

Experimental: Abatacept - Abatacept for subcutaneous injection 125mg/mL in 1 mL pre-filled syringe for 6 months followed by Open-Label Abatacept for subcutaneous injection 125mg/mL in 1 mL pre-filled syringe for 6 months

Placebo Comparator: Placebo - Placebo for Abatacept for subcutaneous injection 125mg/mL in 1 mL pre-filled syringe for 6 months followed by Open-Label Abatacept for subcutaneous injection 125mg/mL in 1 mL pre-filled syringe for 6 months


Other interventions: Abatacept


Other interventions: Placebo


Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Day 169
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 169
Secondary outcome [2] 0 0
Change From Baseline in the Stimulated Whole Salivary Flow - The mean change from baseline in the stimulated whole salivary flow at Day 169
Timepoint [2] 0 0
Day 169
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [15] 0 0
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.
Timepoint [15] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [16] 0 0
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.
Timepoint [16] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [17] 0 0
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.
Timepoint [17] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [18] 0 0
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
Timepoint [18] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [19] 0 0
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.
Timepoint [19] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [20] 0 0
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)
Timepoint [20] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
Secondary outcome [21] 0 0
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.
Timepoint [21] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [22] 0 0
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.
Timepoint [22] 0 0
Day 85, Day 169
Secondary outcome [23] 0 0
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]
Timepoint [23] 0 0
Day 85, Day 169
Secondary outcome [24] 0 0
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.
Timepoint [24] 0 0
Day 85, Day 169
Secondary outcome [25] 0 0
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.
Timepoint [25] 0 0
Day 85, Day 169
Secondary outcome [26] 0 0
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.
Timepoint [26] 0 0
Day 85, Day 169
Secondary outcome [27] 0 0
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
Timepoint [27] 0 0
Day 1, 29, 57, 85, 113, 141, 169
Secondary outcome [28] 0 0
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
Timepoint [28] 0 0
Day 1, 29, 57, 85, 113, 141, 169
Secondary outcome [29] 0 0
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
Timepoint [29] 0 0
Day 29, 57, 85, 113, 141, 169
Secondary outcome [30] 0 0
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
Timepoint [30] 0 0
Day 29, 57, 85, 113, 141, 169
Secondary outcome [31] 0 0
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
Timepoint [31] 0 0
Day 29, 57, 85, 113, 141, 169
Secondary outcome [32] 0 0
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
Timepoint [32] 0 0
Day 85, Day 169
Secondary outcome [33] 0 0
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
Timepoint [33] 0 0
Day 85, Day 169
Secondary outcome [34] 0 0
Geometric Mean of Trough Concentration (Cmin) of Abatacept - Geometric mean of trough concentration (Cmin) of abatacept at all measured time points.
Timepoint [34] 0 0
Day 29, 85, 113, 141, 169
Secondary outcome [35] 0 0
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).
Timepoint [35] 0 0
Day 85 db, day 169 db, post treatment day 85
Secondary outcome [36] 0 0
Summary of Adverse Events: Double Blind Period - Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation
Timepoint [36] 0 0
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.
Secondary outcome [37] 0 0
Laboratory Marked Abnormalities: Double Blind Period - Laboratory values meeting the marked abnormality criteria
Timepoint [37] 0 0
Day 1 up to first dose of OL abatacept or up to 56 post last dose in double -blind for those not in OL.
Secondary outcome [38] 0 0
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.
Timepoint [38] 0 0
Day 365, post open label treatment day 85
Secondary outcome [39] 0 0
Summary of Adverse Events: Cumulative Abatacept Period - Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation
Timepoint [39] 0 0
Day 365 and 3 months of follow up approximately 450 Days
Secondary outcome [40] 0 0
Laboratory Marked Abnormalities: Cumulative Abatacept Period - Laboratory values meeting the marked abnormality criteria
Timepoint [40] 0 0
Day 365 and 3 months of follow up approximately 450 Days

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com



- 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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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/exclusion criteria could apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Maroochydore
Recruitment hospital [2] 0 0
Local Institution - Woodville
Recruitment hospital [3] 0 0
Local Institution - Camberwell
Recruitment hospital [4] 0 0
Local Institution - Nedlands
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
3124 - Camberwell
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Caba
Country [16] 0 0
Argentina
State/province [16] 0 0
Cordoba
Country [17] 0 0
Brazil
State/province [17] 0 0
Bahia
Country [18] 0 0
Brazil
State/province [18] 0 0
ES
Country [19] 0 0
Brazil
State/province [19] 0 0
RIO Grande DO SUL
Country [20] 0 0
Brazil
State/province [20] 0 0
Sao Paulo
Country [21] 0 0
Czechia
State/province [21] 0 0
Brno
Country [22] 0 0
France
State/province [22] 0 0
Bordeaux
Country [23] 0 0
France
State/province [23] 0 0
Le Kremlin Bicetre Cedex
Country [24] 0 0
France
State/province [24] 0 0
Marseille
Country [25] 0 0
France
State/province [25] 0 0
Montpellier Cedex 5
Country [26] 0 0
France
State/province [26] 0 0
Paris Cedex 10
Country [27] 0 0
France
State/province [27] 0 0
Strasbourg
Country [28] 0 0
Germany
State/province [28] 0 0
Freiburg
Country [29] 0 0
Germany
State/province [29] 0 0
Hannover
Country [30] 0 0
Germany
State/province [30] 0 0
Wuppertal
Country [31] 0 0
Italy
State/province [31] 0 0
Milano
Country [32] 0 0
Italy
State/province [32] 0 0
Udine
Country [33] 0 0
Japan
State/province [33] 0 0
Aichi
Country [34] 0 0
Japan
State/province [34] 0 0
Fukuoka
Country [35] 0 0
Japan
State/province [35] 0 0
Hokkaido
Country [36] 0 0
Japan
State/province [36] 0 0
Hyogo
Country [37] 0 0
Japan
State/province [37] 0 0
Ibaraki
Country [38] 0 0
Japan
State/province [38] 0 0
Kyoto
Country [39] 0 0
Japan
State/province [39] 0 0
Miyagi
Country [40] 0 0
Japan
State/province [40] 0 0
Nagasaki
Country [41] 0 0
Japan
State/province [41] 0 0
Okayama
Country [42] 0 0
Japan
State/province [42] 0 0
Shizuoka
Country [43] 0 0
Japan
State/province [43] 0 0
Tokyo
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Daegu
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Gwangju
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Seoul
Country [47] 0 0
Mexico
State/province [47] 0 0
Guanajuato
Country [48] 0 0
Mexico
State/province [48] 0 0
Nuevo LEON
Country [49] 0 0
Mexico
State/province [49] 0 0
Distrito Federal
Country [50] 0 0
Mexico
State/province [50] 0 0
San Luis Potosi
Country [51] 0 0
Puerto Rico
State/province [51] 0 0
San Juan
Country [52] 0 0
Sweden
State/province [52] 0 0
Solna
Country [53] 0 0
Sweden
State/province [53] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in
patients with Sjögren's Syndrome.
Trial website
https://clinicaltrials.gov/show/NCT02915159
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications