Clinical trial NCT02915159: A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome
Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Primary Sjögrens Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sjogrens Disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-09-26
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
timeFrame: Day 169
Secondary outcomes:
measure: Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI)
timeFrame: Day 169
measure: Change From Baseline in the Stimulated Whole Salivary Flow
timeFrame: Day 169
measure: Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
measure: Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
measure: Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
measure: Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
measure: Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
measure: Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
measure: Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
measure: Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
measure: Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
measure: Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
measure: Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
measure: Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
measure: Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
measure: Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
measure: Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
measure: Change From Baseline at All Measured Time Points in the ESSDAI
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
measure: Change From Baseline at All Measured Time Points in the ESSPRI
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
measure: Change From Baseline in Components of ESSDAI
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
measure: Change From Baseline in ESSPRI Components
timeFrame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
measure: Change From Baseline in Schirmer's Test
timeFrame: Day 85, Day 169
measure: Change From Baseline in the Ocular Staining Score (OSS)
timeFrame: Day 85, Day 169
measure: Change From Baseline in Tear Break-up Time
timeFrame: Day 85, Day 169
measure: Change From Baseline in Unstimulated Salivary Flow
timeFrame: Day 85, Day 169
measure: Change From Baseline in Stimulated Salivary Flow
timeFrame: Day 85, Day 169
measure: Change From Baseline in Numeric Rating Scale for Mouth Dryness
timeFrame: Day 1, 29, 57, 85, 113, 141, 169
measure: Change From Baseline in Numeric Rating Scale for Eye Dryness
timeFrame: Day 1, 29, 57, 85, 113, 141, 169
measure: Change From Baseline in Participant Assessment of Disease Activity
timeFrame: Day 29, 57, 85, 113, 141, 169
measure: Change From Baseline in Physician Global Assessment of Disease Activity
timeFrame: Day 29, 57, 85, 113, 141, 169
measure: Change From Baseline in Patient Fatigue
timeFrame: Day 29, 57, 85, 113, 141, 169
measure: Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI)
timeFrame: Day 85, Day 169
measure: Change From Baseline in 36-item Short Form Health Survey (SF-36)
timeFrame: Day 85, Day 169
measure: Geometric Mean of Trough Concentration (Cmin) of Abatacept
timeFrame: Day 29, 85, 113, 141, 169
measure: Percentage of Participants With a Positive Antibody Response
timeFrame: Day 85 db, day 169 db, post treatment day 85
measure: Summary of Adverse Events: Double Blind Period
timeFrame: Day 1 up to first dose of Open Label Treatment Period (OLTP) abatacept or up to 56 post last dose in double -blind for those not in OL.
measure: Laboratory Marked Abnormalities: Double Blind Period
timeFrame: Day 1 up to first dose of OL abatacept or up to 56 post last dose in double -blind for those not in OL.
measure: Percentage of Participants With a Positive Antibody Response in the Cumulative Abatacept Period
timeFrame: Day 365, post open label treatment day 85
measure: Summary of Adverse Events: Cumulative Abatacept Period
timeFrame: Day 365 and 3 months of follow up approximately 450 Days
measure: Laboratory Marked Abnormalities: Cumulative Abatacept Period
timeFrame: Day 365 and 3 months of follow up approximately 450 Days
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: St. Jude Hospital Yorba Linda
state: California
city: Riverside
country: United States
facility: Riverside Medical Clinic
state: California
city: Lakewood
country: United States
facility: Colorado Arthritis Associates
state: Colorado
city: Lawrenceville
country: United States
facility: North Georgia Rheumatology Group
state: Georgia
city: Boise
country: United States
facility: Intermountain Research Center Inc.
state: Idaho
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Eagan
country: United States
facility: St. Paul Rheumatology, P.A.
state: Minnesota
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: Charlotte
country: United States
facility: Local Institution
state: North Carolina
city: Charlotte
country: United States
facility: Joint and Muscle Medical Care and Research Institute (JMMCRI)
state: North Carolina
city: Durham
country: United States
facility: Duke Clinical Research Unit, Duke Univ Med Ctr, Duke South
state: North Carolina
city: Oklahoma City
country: United States
facility: Health Research Of Oklahoma
state: Oklahoma
city: Bethlehem
country: United States
facility: East Penn Rheumatology
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Dallas
country: United States
facility: Scott Zashin Inc.
state: Texas
city: Capital Federal
country: Argentina
facility: Organizacion Medica De Investigacion S.A. (Omi)
state: Buenos Aires
city: Ciudad Autonoma Beunos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: San Fernando
country: Argentina
facility: Instituto de Asistencia Reumatologica Integral
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Caba
country: Argentina
facility: Consultorios Medicos Dr. Catalan Pellet
city: Cordoba
country: Argentina
facility: Instituto Reumatologico Strusberg
city: Maroochydore
country: Australia
facility: Local Institution
state: Queensland
city: Woodville
country: Australia
facility: Local Institution
state: South Australia
city: Camberwell
country: Australia
facility: Local Institution
state: Victoria
city: Nedlands
country: Australia
facility: Local Institution
state: Western Australia
city: Savaldor
country: Brazil
facility: Local Institution
state: Bahia
city: Vitoria
country: Brazil
facility: Local Institution
state: ES
city: Porto Alegre
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Brno
country: Czechia
facility: Revmatologie s.r.o.
city: Bordeaux
country: France
facility: Local Institution
city: Le Kremlin Bicetre Cedex
country: France
facility: Local Institution
city: Marseille
country: France
facility: Hopital Europeen
city: Marseille
country: France
facility: Local Institution
city: Montpellier Cedex 5
country: France
facility: Hopital Lapeyronie
city: Paris Cedex 10
country: France
facility: Local Institution
city: Strasbourg
country: France
facility: Local Institution
city: Freiburg
country: Germany
facility: Medizinische Universitaetsklinik Freiburg
city: Hannover
country: Germany
facility: Med Hochschule Hannover
city: Wuppertal
country: Germany
facility: Krankenhaus St. Josef
city: Milano
country: Italy
facility: Local Institution
city: Udine
country: Italy
facility: Ospedale Santa Maria Della Misericordia
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Kitakyushu-shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Nishinomiya-shi
country: Japan
facility: Local Institution
state: Hyogo
city: Tsukuba-shi
country: Japan
facility: Local Institution
state: Ibaraki
city: Kamigyo-ku
country: Japan
facility: Local Institution
state: Kyoto
city: Sendai-shi
country: Japan
facility: Local Institution
state: Miyagi
city: Nagasaki-shi
country: Japan
facility: Local Institution
state: Nagasaki
city: Kurashiki-shi
country: Japan
facility: Local Institution
state: Okayama
city: Hamamatsu-shi
country: Japan
facility: Local Institution
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Meguro-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Gwangju
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Leon
country: Mexico
facility: Consultorio Medico de Reumatologia Dr.Jesus Alberto Lopez Garcia
state: Guanajuato
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez
state: Nuevo LEON
city: Distrito Federal
country: Mexico
facility: Local Institution
city: San Luis Potosi
country: Mexico
facility: Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
city: San Juan
country: Puerto Rico
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
city: Solna
country: Sweden
facility: Local Institution
city: Uppsala
country: Sweden
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: