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

Completed · Phase 3 · Has a placebo group

Conditions studied: Sjogrens Disease

In brief

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

Key facts

Study ID

NCT02915159

Run by

Bristol-Myers Squibb

People needed

250

Starts

2016-12-06

Expected to finish

2019-07-23

Last updated by the study team

2020-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Riverside Medical Clinic — Riverside, California, United States
• Colorado Arthritis Associates — Lakewood, Colorado, United States
• North Georgia Rheumatology Group — Lawrenceville, Georgia, United States
• Intermountain Research Center Inc. — Boise, Idaho, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• St. Paul Rheumatology, P.A. — Eagan, Minnesota, United States
• Northwell Health — Great Neck, New York, United States
• Local Institution — Charlotte, North Carolina, United States
• Joint and Muscle Medical Care and Research Institute (JMMCRI) — Charlotte, North Carolina, United States
• Duke Clinical Research Unit, Duke Univ Med Ctr, Duke South — Durham, North Carolina, United States
• Health Research Of Oklahoma — Oklahoma City, Oklahoma, United States
• East Penn Rheumatology — Bethlehem, Pennsylvania, United States
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• West Tennessee Research Institute — Jackson, Tennessee, United States
• Metroplex Clinical Research Center — Dallas, Texas, United States
• Scott Zashin Inc. — Dallas, Texas, United States
• Organizacion Medica De Investigacion S.A. (Omi) — Capital Federal, Buenos Aires, Argentina
• Local Institution — Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina
• Instituto de Asistencia Reumatologica Integral — San Fernando, Buenos Aires, Argentina
• Local Institution — Buenos Aires, Argentina
• Consultorios Medicos Dr. Catalan Pellet — CABA, Argentina
• Instituto Reumatologico Strusberg — Córdoba, Argentina
• St. Jude Hospital Yorba Linda — Fullerton, California, United States

Full record on ClinicalTrials.gov

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