CompletedPhase 3

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

United States250 participantsStarted 2016-12-06

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)

Timeframe: Day 169

Trial details

NCT IDNCT02915159

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-08-07

Results submitted2019-08-07

View on ClinicalTrials.gov More Sjogrens Disease trials