A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome
NCT ID: NCT02915159
Last Updated: 2020-08-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
250 participants
INTERVENTIONAL
2016-12-06
2019-07-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Abatacept
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
Abatacept
Placebo
Interventions
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Abatacept
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Active life-threatening or organ-threatening complications of Sjögren's-syndrome
* Other medical condition associated with sicca syndrome
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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St. Jude Hospital Yorba Linda
Fullerton, California, United States
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
Local Institution
Maroochydore, Queensland, Australia
Local Institution
Woodville, South Australia, Australia
Local Institution
Camberwell, Victoria, Australia
Local Institution
Nedlands, Western Australia, Australia
Local Institution
Vitória, Espírito Santo, Brazil
Local Institution
Savaldor, Estado de Bahia, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
São Paulo, , Brazil
Revmatologie s.r.o.
Brno, , Czechia
Local Institution
Bordeaux, , France
Local Institution
Le Kremlin-Bicêtre, , France
Hopital Europeen
Marseille, , France
Local Institution
Marseille, , France
Hopital Lapeyronie
Montpellier, , France
Local Institution
Paris, , France
Local Institution
Strasbourg, , France
Medizinische Universitaetsklinik Freiburg
Freiburg im Breisgau, , Germany
Med Hochschule Hannover
Hanover, , Germany
Krankenhaus St. Josef
Wuppertal, , Germany
Local Institution
Milan, , Italy
Ospedale Santa Maria Della Misericordia
Udine, , Italy
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Kitakyushu-shi, Fukuoka, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Nishinomiya-shi, Hyōgo, Japan
Local Institution
Tsukuba, Ibaraki, Japan
Local Institution
Kamigyō-ku, Kyoto, Japan
Local Institution
Sendai, Miyagi, Japan
Local Institution
Nagasaki, Nagasaki, Japan
Local Institution
Kurashiki-shi, Okayama-ken, Japan
Local Institution
Hamamatsu, Shizuoka, Japan
Local Institution
Chuo-ku, Tokyo, Japan
Local Institution
Itabashi-ku, Tokyo, Japan
Local Institution
Meguro-ku, Tokyo, Japan
Local Institution
Shinjuku-Ku, Tokyo, Japan
Consultorio Medico de Reumatologia Dr.Jesus Alberto Lopez Garcia
León, Guanajuato, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico
Local Institution
Distrito Federal, , Mexico
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
San Luis Potosí City, , Mexico
Local Institution
San Juan, , Puerto Rico
Local Institution
San Juan, , Puerto Rico
Local Institution
Daegu, , South Korea
Local Institution
Gwangju, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Solna, , Sweden
Local Institution
Uppsala, , Sweden
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2016-001948-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM101-603
Identifier Type: -
Identifier Source: org_study_id
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