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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
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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
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Secondary ID [1]
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2016-001948-19
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Secondary ID [2]
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IM101-603
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sjogrens Disease
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Condition category
Condition code
Inflammatory and Immune System
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Rheumatoid arthritis
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Musculoskeletal
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
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Assessment method [1]
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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
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Timepoint [1]
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Day 169
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Secondary outcome [1]
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Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI)
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Assessment method [1]
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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.
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Timepoint [1]
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Day 169
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Secondary outcome [2]
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Change From Baseline in the Stimulated Whole Salivary Flow
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Assessment method [2]
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The mean change from baseline in the stimulated whole salivary flow at Day 169
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Timepoint [2]
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Day 169
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Secondary outcome [3]
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Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population
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Assessment method [3]
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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
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Timepoint [3]
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Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Secondary outcome [4]
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Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3
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Assessment method [4]
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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
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Timepoint [4]
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Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Secondary outcome [5]
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Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3
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Assessment method [5]
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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
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Timepoint [5]
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Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Secondary outcome [6]
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Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population
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Assessment method [6]
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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
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Timepoint [6]
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Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Secondary outcome [7]
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Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population
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Assessment method [7]
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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
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Timepoint [7]
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Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Secondary outcome [8]
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Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population
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Assessment method [8]
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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
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Timepoint [8]
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Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Secondary outcome [9]
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Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3
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Assessment method [9]
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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
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Timepoint [9]
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Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Secondary outcome [10]
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Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3
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Assessment method [10]
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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
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Timepoint [10]
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Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Secondary outcome [11]
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Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3
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Assessment method [11]
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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
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Timepoint [11]
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Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Secondary outcome [12]
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Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3
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Assessment method [12]
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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
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Timepoint [12]
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Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Secondary outcome [13]
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Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3
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Assessment method [13]
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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
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Timepoint [13]
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Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Secondary outcome [14]
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Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3
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Assessment method [14]
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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
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Timepoint [14]
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Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Secondary outcome [15]
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Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points
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Assessment method [15]
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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.
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Timepoint [15]
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Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Secondary outcome [16]
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Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points
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Assessment method [16]
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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.
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Timepoint [16]
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Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Secondary outcome [17]
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Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point
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Assessment method [17]
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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.
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Timepoint [17]
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Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Secondary outcome [18]
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Change From Baseline at All Measured Time Points in the ESSDAI
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Assessment method [18]
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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
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Timepoint [18]
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Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Secondary outcome [19]
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Change From Baseline at All Measured Time Points in the ESSPRI
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Assessment method [19]
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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.
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Timepoint [19]
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Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Secondary outcome [20]
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Change From Baseline in Components of ESSDAI
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Assessment method [20]
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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)
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Timepoint [20]
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Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
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Secondary outcome [21]
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Change From Baseline in ESSPRI Components
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Assessment method [21]
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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.
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Timepoint [21]
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Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
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Secondary outcome [22]
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Change From Baseline in Schirmer's Test
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Assessment method [22]
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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.
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Timepoint [22]
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Day 85, Day 169
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Secondary outcome [23]
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Change From Baseline in the Ocular Staining Score (OSS)
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Assessment method [23]
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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]
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Timepoint [23]
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Day 85, Day 169
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Secondary outcome [24]
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Change From Baseline in Tear Break-up Time
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Assessment method [24]
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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.
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Timepoint [24]
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Day 85, Day 169
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Secondary outcome [25]
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Change From Baseline in Unstimulated Salivary Flow
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Assessment method [25]
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The mean change from baseline in unstimulated whole salivary flow at all measured time points up to Day 169.
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Timepoint [25]
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Day 85, Day 169
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Secondary outcome [26]
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Change From Baseline in Stimulated Salivary Flow
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Assessment method [26]
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The mean change from baseline in Stimulated whole salivary flow at all measured time points up to Day 169.
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Timepoint [26]
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Day 85, Day 169
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Secondary outcome [27]
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Change From Baseline in Numeric Rating Scale for Mouth Dryness
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Assessment method [27]
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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
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Timepoint [27]
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Day 1, 29, 57, 85, 113, 141, 169
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Secondary outcome [28]
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Change From Baseline in Numeric Rating Scale for Eye Dryness
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Assessment method [28]
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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
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Timepoint [28]
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0
Day 1, 29, 57, 85, 113, 141, 169
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Secondary outcome [29]
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Change From Baseline in Participant Assessment of Disease Activity
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Assessment method [29]
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0
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
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Timepoint [29]
0
0
Day 29, 57, 85, 113, 141, 169
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Secondary outcome [30]
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Change From Baseline in Physician Global Assessment of Disease Activity
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Assessment method [30]
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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
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Timepoint [30]
0
0
Day 29, 57, 85, 113, 141, 169
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Secondary outcome [31]
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Change From Baseline in Patient Fatigue
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Assessment method [31]
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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
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Timepoint [31]
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0
Day 29, 57, 85, 113, 141, 169
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Secondary outcome [32]
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0
Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI)
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Assessment method [32]
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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
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Timepoint [32]
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0
Day 85, Day 169
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Secondary outcome [33]
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0
Change From Baseline in 36-item Short Form Health Survey (SF-36)
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Assessment method [33]
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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
Query!
Timepoint [33]
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0
Day 85, Day 169
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Secondary outcome [34]
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0
Geometric Mean of Trough Concentration (Cmin) of Abatacept
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Assessment method [34]
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Geometric mean of trough concentration (Cmin) of abatacept at all measured time points.
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Timepoint [34]
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Day 29, 85, 113, 141, 169
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Secondary outcome [35]
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Percentage of Participants With a Positive Antibody Response
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Assessment method [35]
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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).
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Timepoint [35]
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0
Day 85 db, day 169 db, post treatment day 85
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Secondary outcome [36]
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Summary of Adverse Events: Double Blind Period
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Assessment method [36]
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Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation
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Timepoint [36]
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Day 1 up to first dose of Open Label Treatment Period (OLTP) abatacept or up to 56 post last dose in double -blind for those not in OL.
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Secondary outcome [37]
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0
Laboratory Marked Abnormalities: Double Blind Period
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Assessment method [37]
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Laboratory values meeting the marked abnormality criteria
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Timepoint [37]
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Day 1 up to first dose of OL abatacept or up to 56 post last dose in double -blind for those not in OL.
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Secondary outcome [38]
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Percentage of Participants With a Positive Antibody Response in the Cumulative Abatacept Period
Query!
Assessment method [38]
0
0
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.
Query!
Timepoint [38]
0
0
Day 365, post open label treatment day 85
Query!
Secondary outcome [39]
0
0
Summary of Adverse Events: Cumulative Abatacept Period
Query!
Assessment method [39]
0
0
Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation
Query!
Timepoint [39]
0
0
Day 365 and 3 months of follow up approximately 450 Days
Query!
Secondary outcome [40]
0
0
Laboratory Marked Abnormalities: Cumulative Abatacept Period
Query!
Assessment method [40]
0
0
Laboratory values meeting the marked abnormality criteria
Query!
Timepoint [40]
0
0
Day 365 and 3 months of follow up approximately 450 Days
Query!
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)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
6/12/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
23/07/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
250
Query!
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Local Institution - Maroochydore
Query!
Recruitment hospital [2]
0
0
Local Institution - Woodville
Query!
Recruitment hospital [3]
0
0
Local Institution - Camberwell
Query!
Recruitment hospital [4]
0
0
Local Institution - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [2]
0
0
5011 - Woodville
Query!
Recruitment postcode(s) [3]
0
0
3124 - Camberwell
Query!
Recruitment postcode(s) [4]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
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Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
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Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
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Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Idaho
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Maryland
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Massachusetts
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Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Minnesota
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Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New York
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Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
North Carolina
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Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Oklahoma
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Pennsylvania
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Tennessee
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
Argentina
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State/province [14]
0
0
Buenos Aires
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Caba
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
Cordoba
Query!
Country [17]
0
0
Brazil
Query!
State/province [17]
0
0
Bahia
Query!
Country [18]
0
0
Brazil
Query!
State/province [18]
0
0
ES
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
RIO Grande DO SUL
Query!
Country [20]
0
0
Brazil
Query!
State/province [20]
0
0
Sao Paulo
Query!
Country [21]
0
0
Czechia
Query!
State/province [21]
0
0
Brno
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Bordeaux
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Le Kremlin Bicetre Cedex
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Marseille
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Montpellier Cedex 5
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Paris Cedex 10
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Strasbourg
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Freiburg
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Hannover
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Wuppertal
Query!
Country [31]
0
0
Italy
Query!
State/province [31]
0
0
Milano
Query!
Country [32]
0
0
Italy
Query!
State/province [32]
0
0
Udine
Query!
Country [33]
0
0
Japan
Query!
State/province [33]
0
0
Aichi
Query!
Country [34]
0
0
Japan
Query!
State/province [34]
0
0
Fukuoka
Query!
Country [35]
0
0
Japan
Query!
State/province [35]
0
0
Hokkaido
Query!
Country [36]
0
0
Japan
Query!
State/province [36]
0
0
Hyogo
Query!
Country [37]
0
0
Japan
Query!
State/province [37]
0
0
Ibaraki
Query!
Country [38]
0
0
Japan
Query!
State/province [38]
0
0
Kyoto
Query!
Country [39]
0
0
Japan
Query!
State/province [39]
0
0
Miyagi
Query!
Country [40]
0
0
Japan
Query!
State/province [40]
0
0
Nagasaki
Query!
Country [41]
0
0
Japan
Query!
State/province [41]
0
0
Okayama
Query!
Country [42]
0
0
Japan
Query!
State/province [42]
0
0
Shizuoka
Query!
Country [43]
0
0
Japan
Query!
State/province [43]
0
0
Tokyo
Query!
Country [44]
0
0
Korea, Republic of
Query!
State/province [44]
0
0
Daegu
Query!
Country [45]
0
0
Korea, Republic of
Query!
State/province [45]
0
0
Gwangju
Query!
Country [46]
0
0
Korea, Republic of
Query!
State/province [46]
0
0
Seoul
Query!
Country [47]
0
0
Mexico
Query!
State/province [47]
0
0
Guanajuato
Query!
Country [48]
0
0
Mexico
Query!
State/province [48]
0
0
Nuevo LEON
Query!
Country [49]
0
0
Mexico
Query!
State/province [49]
0
0
Distrito Federal
Query!
Country [50]
0
0
Mexico
Query!
State/province [50]
0
0
San Luis Potosi
Query!
Country [51]
0
0
Puerto Rico
Query!
State/province [51]
0
0
San Juan
Query!
Country [52]
0
0
Sweden
Query!
State/province [52]
0
0
Solna
Query!
Country [53]
0
0
Sweden
Query!
State/province [53]
0
0
Uppsala
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in
patients with Sjögren's Syndrome.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02915159
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02915159
Download to PDF