Trial · NCT02915159
A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome
NCT02915159, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2020-01-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome. Trials, record NCT02915159. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02915159
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome
- NCT number
- NCT02915159
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 250 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Sjogrens Disease
- Interventions
- Abatacept, Placebo
- First posted
- 2016-09-26
- Last updated
- 2020-08-10
- Other registries' IDs
- eudract:2016-001948-19
- Results first posted
- 2020-01-02
Source ClinicalTrials.gov
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 registered outcomesOutcomes41
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) | Day 169 | Modified Intent-to-treat (ITT) analysis population: all randomized participants who receive at least one dose of study medication. | Score on a Scale | MEAN |
| SECONDARY | Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI) | Day 169 | Modified ITT Population | Score on a Scale | MEAN |
| SECONDARY | Change From Baseline in the Stimulated Whole Salivary Flow | Day 169 | Modified ITT Population with Stimulated Whole Salivary Flow of at Least 0.1 mL/min at Both Screening and Baseline | mL/min | MEAN |
| SECONDARY | 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 | Modified ITT Population | Scores on a scale | MEAN |
| SECONDARY | 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 | Modified ITT Population with Baseline Tender plus Swollen Joint Count of at Least 3 | Scores on a scale | MEAN |
| SECONDARY | 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 | Modified ITT Population with Baseline Tender plus Swollen Joint Count of Less than 3 | Scores on a scale | MEAN |
| SECONDARY | 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 | Modified intent to treat (ITT) | Joint Count | MEAN |
| SECONDARY | 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 | Modified intent to treat (ITT) | mg/L | MEAN |
| SECONDARY | 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 | Modified intent to treat (ITT) | Scores on a Scale | MEAN |
| SECONDARY | 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 | Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of at least 3 | Joint Count | MEAN |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 outcomesResults by group729
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) | Abatacept - Double Blind Treatment Period | -3.2 | 95% Confidence Interval -4.6 to -1.9 | Score on a Scale | |
| Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) | Placebo - Double Blind Treatment Period | -3.7 | 95% Confidence Interval -5.0 to -2.4 | Score on a Scale | |
| Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI) | Abatacept - Double Blind Treatment Period | -1.26 | 95% Confidence Interval -1.88 to -0.64 | Score on a Scale | |
| Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI) | Placebo - Double Blind Treatment Period | -1.52 | 95% Confidence Interval -2.12 to -0.93 | Score on a Scale | |
| Change From Baseline in the Stimulated Whole Salivary Flow | Abatacept - Double Blind Treatment Period | 0.057 | 95% Confidence Interval -0.115 to 0.230 | mL/min | |
| Change From Baseline in the Stimulated Whole Salivary Flow | Placebo - Double Blind Treatment Period | 0.108 | 95% Confidence Interval -0.060 to 0.276 | mL/min | |
| Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population | Abatacept - Double Blind Treatment Period | Day 29 | -0.4 | 95% Confidence Interval -0.6 to -0.2 | Scores on a scale |
| Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population | Placebo - Double Blind Treatment Period | Day 29 | -0.4 | 95% Confidence Interval -0.6 to -0.2 | Scores on a scale |
| Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population | Abatacept - Double Blind Treatment Period | Day 57 | -0.6 | 95% Confidence Interval -0.8 to -0.4 | Scores on a scale |
| Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population | Placebo - Double Blind Treatment Period | Day 57 | -0.7 | 95% Confidence Interval -0.9 to -0.4 | Scores on a scale |
1 to 10 of 729Source ClinicalTrials.gov
See all 729 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Abatacept - Double Blind Treatment Period | 92 | |
| Overall Study | STARTED | Placebo - Double Blind Treatment Period | 95 | |
| Overall Study | COMPLETED | Abatacept - Double Blind Treatment Period | 81 | |
| Overall Study | COMPLETED | Placebo - Double Blind Treatment Period | 87 | |
| Overall Study | NOT COMPLETED | Abatacept - Double Blind Treatment Period | 11 | |
| Overall Study | NOT COMPLETED | Placebo - Double Blind Treatment Period | 8 |
Source ClinicalTrials.gov
Adverse events135
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain upper | Gastrointestinal disorders | Abatacept - Double Blind Treatment Period | 5 | 92 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo - Double Blind Treatment Period | 0 | 95 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Abatacept - Open Label Treatment Period | 4 | 165 | |
| other | Diarrhoea | Gastrointestinal disorders | Abatacept - Double Blind Treatment Period | 11 | 92 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo - Double Blind Treatment Period | 4 | 95 | |
| other | Diarrhoea | Gastrointestinal disorders | Abatacept - Open Label Treatment Period | 9 | 165 | |
| other | Nausea | Gastrointestinal disorders | Abatacept - Double Blind Treatment Period | 9 | 92 | |
| other | Nausea | Gastrointestinal disorders | Placebo - Double Blind Treatment Period | 4 | 95 | |
| other | Nausea | Gastrointestinal disorders | Abatacept - Open Label Treatment Period | 1 | 165 | |
| other | Nasopharyngitis | Infections and infestations | Abatacept - Double Blind Treatment Period | 11 | 92 |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abatacept - Double Blind Treatment Period | 0 | 92 |
| Total, all-cause mortality | Placebo - Double Blind Treatment Period | 1 | 95 |
| Total, all-cause mortality | Abatacept - Open Label Treatment Period | 1 | 178 |
| Total, other adverse events | Abatacept - Double Blind Treatment Period | 47 | 92 |
| Total, other adverse events | Placebo - Double Blind Treatment Period | 40 | 95 |
| Total, other adverse events | Abatacept - Open Label Treatment Period | 61 | 165 |
| Total, serious adverse events | Abatacept - Double Blind Treatment Period | 9 | 92 |
| Total, serious adverse events | Placebo - Double Blind Treatment Period | 3 | 95 |
| Total, serious adverse events | Abatacept - Open Label Treatment Period | 19 | 178 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02915159
GET https://conductscience.org/api/trials/v1/NCT02915159/registered?page=2