Phase 3 N=187 Randomized Quadruple-blind Treatment

A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome

Sjogrens Disease

Bottom Line

View on ClinicalTrials.gov: NCT02915159 ↗

Enrolled (actual)

187

Serious AEs

8.5%

Results posted

Jan 2020

Primary outcome: Primary: Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) — -3.2; -3.7 Score on a Scale — p=0.4421

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Abatacept (Biological); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Aug 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)	-3.2; -3.7	0.4421
SECONDARY Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI)	-1.26; -1.52	0.3367
SECONDARY Change From Baseline in the Stimulated Whole Salivary Flow	0.057; 0.108	.5841
SECONDARY Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population	-0.4; -0.4; -0.6; -0.7; -0.8; -0.8	—
SECONDARY Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3	-0.5; -0.6; -0.9; -1.0; -1.1; -1.2	—
SECONDARY Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3	-0.3; -0.2; -0.2; -0.2; -0.4; -0.4	—
SECONDARY Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population	-1.7; -1.9; -0.5; -0.6; -2.6; -2.9	—
SECONDARY Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population	0.3; 0.6; -0.1; 1.8; -0.2; 3.0	—
SECONDARY Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population	-4.0; -7.1; -7.5; -6.3; -10.4; -10.2	—
SECONDARY Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3	-2.8; -3.0; -0.7; -0.9; -4.1; -4.8	—
SECONDARY Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3	-1.5; -0.7; -1.3; 1.3; -2.2; 3.8	—
SECONDARY Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3	0.6; -3.5; -3.5; -6.5; -7.5; -7.7	—
SECONDARY Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3	-0.1; -0.2; 0.1; 0.1; -0.2; 0.1	—
SECONDARY Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3	2.1; 1.8; 0.5; 1.0; 1.4; 0.1	—
SECONDARY Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3	-10.3; -11.8; -12.4; -4.8; -14.0; -13.5	—
SECONDARY Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points	37; 34.7; 37; 44.2; 48.9; 50.5	—
SECONDARY Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points	19.6; 13.7; 26.1; 24.2; 34.8; 32.6	—
SECONDARY Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point	31.5; 38.9; 42.4; 47.4; 44.6; 55.8	—
SECONDARY Change From Baseline at All Measured Time Points in the ESSDAI	-10.9; -12.6; -24.1; -18.9; -26.0; -25.4	—
SECONDARY Change From Baseline at All Measured Time Points in the ESSPRI	-0.32; -0.54; -0.81; -0.82; -0.83; -1.20	—
SECONDARY Change From Baseline in Components of ESSDAI	-0.3; -0.4; -0.6; -0.5; -0.2; -0.2	—
SECONDARY Change From Baseline in ESSPRI Components	-0.21; -0.26; -0.57; -1.01; -0.34; -0.53	—
SECONDARY Change From Baseline in Schirmer's Test	1.9; 1.5; 0.1; 0.8; 1.10; 1.41	—
SECONDARY Change From Baseline in the Ocular Staining Score (OSS)	-1.7; -0.5; -0.6; 0.4; -1.15; -0.06	—
SECONDARY Change From Baseline in Tear Break-up Time	-0.13; 0.18; -0.70; -0.12; -0.41; 0.09	—
SECONDARY Change From Baseline in Unstimulated Salivary Flow	0.106; 0.158; 0.051; 0.105	—
SECONDARY Change From Baseline in Stimulated Salivary Flow	0.11; 0.169; 0.056; 0.108	—
SECONDARY Change From Baseline in Numeric Rating Scale for Mouth Dryness	-0.8; -0.5; -1.3; -0.9; -1.3; -1.1	—
SECONDARY Change From Baseline in Numeric Rating Scale for Eye Dryness	-0.4; -0.3; -0.9; -0.6; -0.9; -0.8	—
SECONDARY Change From Baseline in Participant Assessment of Disease Activity	-4.0; -7.1; -7.5; -6.3; -10.4; -10.2	—
SECONDARY Change From Baseline in Physician Global Assessment of Disease Activity	-10.3; -10.5; -16.2; -16.7; -20.8; -19.4	—
SECONDARY Change From Baseline in Patient Fatigue	-3.08; -3.99; -4.12; -4.02; -4.85; -5.48	—
SECONDARY Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI)	-2.44; -1.56; -2.32; -1.87	—
SECONDARY Change From Baseline in 36-item Short Form Health Survey (SF-36)	1.908; 1.523; 5.248; 4.416; 3.200; 3.721	—
SECONDARY Geometric Mean of Trough Concentration (Cmin) of Abatacept	21.401; 27.543; 25.567; 25.870; 24.522	—
SECONDARY Percentage of Participants With a Positive Antibody Response	1.2; 0; 0	—
SECONDARY Summary of Adverse Events: Double Blind Period	85.9; 71.6; 0; 1.1; 9.8; 3.2	—
SECONDARY Laboratory Marked Abnormalities: Double Blind Period	NA; NA; 0; 0; NA; NA	—
SECONDARY Percentage of Participants With a Positive Antibody Response in the Cumulative Abatacept Period	2.1; 43.2	—
SECONDARY Summary of Adverse Events: Cumulative Abatacept Period	78.7; 0.6; 14.6; 5.6; 3.4; 3.4	—
SECONDARY Laboratory Marked Abnormalities: Cumulative Abatacept Period	NA; 0; NA; 0.6; 0; 0.6	—

Summary

The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in patients with Sjögren's Syndrome.

Eligibility Criteria

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

Inclusion Criteria

EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score of at least 5
Positive anti-SS-A/Ro antibody at screening
meet the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism Classification Criteria for Sjögren's Syndrome (EULAR SS)

Exclusion Criteria

Secondary Sjögrens syndrome
Active life-threatening or organ-threatening complications of Sjögren's-syndrome
Other medical condition associated with sicca syndrome

Other protocol defined inclusion/exclusion criteria could apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02915159). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.