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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02915159




Registration number
NCT02915159
Ethics application status
Date submitted
23/09/2016
Date registered
26/09/2016
Date last updated
10/08/2020

Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome
Scientific 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
Secondary ID [1] 0 0
2016-001948-19
Secondary ID [2] 0 0
IM101-603
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sjogrens Disease 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: 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

Placebo comparator: 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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
Timepoint [1] 0 0
Day 169
Secondary outcome [1] 0 0
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI)
Timepoint [1] 0 0
Day 169
Secondary outcome [2] 0 0
Change From Baseline in the Stimulated Whole Salivary Flow
Timepoint [2] 0 0
Day 169
Secondary outcome [3] 0 0
Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population
Timepoint [3] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [4] 0 0
Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3
Timepoint [4] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [5] 0 0
Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3
Timepoint [5] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [6] 0 0
Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population
Timepoint [6] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [7] 0 0
Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population
Timepoint [7] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [8] 0 0
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population
Timepoint [8] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [9] 0 0
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3
Timepoint [9] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [10] 0 0
Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3
Timepoint [10] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [11] 0 0
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3
Timepoint [11] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [12] 0 0
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3
Timepoint [12] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [13] 0 0
Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3
Timepoint [13] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [14] 0 0
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3
Timepoint [14] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [15] 0 0
Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points
Timepoint [15] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [16] 0 0
Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points
Timepoint [16] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [17] 0 0
Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point
Timepoint [17] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [18] 0 0
Change From Baseline at All Measured Time Points in the ESSDAI
Timepoint [18] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [19] 0 0
Change From Baseline at All Measured Time Points in the ESSPRI
Timepoint [19] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [20] 0 0
Change From Baseline in Components of ESSDAI
Timepoint [20] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
Secondary outcome [21] 0 0
Change From Baseline in ESSPRI Components
Timepoint [21] 0 0
Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Secondary outcome [22] 0 0
Change From Baseline in Schirmer's Test
Timepoint [22] 0 0
Day 85, Day 169
Secondary outcome [23] 0 0
Change From Baseline in the Ocular Staining Score (OSS)
Timepoint [23] 0 0
Day 85, Day 169
Secondary outcome [24] 0 0
Change From Baseline in Tear Break-up Time
Timepoint [24] 0 0
Day 85, Day 169
Secondary outcome [25] 0 0
Change From Baseline in Unstimulated Salivary Flow
Timepoint [25] 0 0
Day 85, Day 169
Secondary outcome [26] 0 0
Change From Baseline in Stimulated Salivary Flow
Timepoint [26] 0 0
Day 85, Day 169
Secondary outcome [27] 0 0
Change From Baseline in Numeric Rating Scale for Mouth Dryness
Timepoint [27] 0 0
Day 1, 29, 57, 85, 113, 141, 169
Secondary outcome [28] 0 0
Change From Baseline in Numeric Rating Scale for Eye Dryness
Timepoint [28] 0 0
Day 1, 29, 57, 85, 113, 141, 169
Secondary outcome [29] 0 0
Change From Baseline in Participant Assessment of Disease Activity
Timepoint [29] 0 0
Day 29, 57, 85, 113, 141, 169
Secondary outcome [30] 0 0
Change From Baseline in Physician Global Assessment of Disease Activity
Timepoint [30] 0 0
Day 29, 57, 85, 113, 141, 169
Secondary outcome [31] 0 0
Change From Baseline in Patient Fatigue
Timepoint [31] 0 0
Day 29, 57, 85, 113, 141, 169
Secondary outcome [32] 0 0
Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI)
Timepoint [32] 0 0
Day 85, Day 169
Secondary outcome [33] 0 0
Change From Baseline in 36-item Short Form Health Survey (SF-36)
Timepoint [33] 0 0
Day 85, Day 169
Secondary outcome [34] 0 0
Geometric Mean of Trough Concentration (Cmin) of Abatacept
Timepoint [34] 0 0
Day 29, 85, 113, 141, 169
Secondary outcome [35] 0 0
Percentage of Participants With a Positive Antibody Response
Timepoint [35] 0 0
Day 85 db, day 169 db, post treatment day 85
Secondary outcome [36] 0 0
Summary of Adverse Events: Double Blind Period
Timepoint [36] 0 0
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.
Secondary outcome [37] 0 0
Laboratory Marked Abnormalities: Double Blind Period
Timepoint [37] 0 0
Day 1 up to first dose of OL abatacept or up to 56 post last dose in double -blind for those not in OL.
Secondary outcome [38] 0 0
Percentage of Participants With a Positive Antibody Response in the Cumulative Abatacept Period
Timepoint [38] 0 0
Day 365, post open label treatment day 85
Secondary outcome [39] 0 0
Summary of Adverse Events: Cumulative Abatacept Period
Timepoint [39] 0 0
Day 365 and 3 months of follow up approximately 450 Days
Secondary outcome [40] 0 0
Laboratory Marked Abnormalities: Cumulative Abatacept Period
Timepoint [40] 0 0
Day 365 and 3 months of follow up approximately 450 Days

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



* 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/07/2019
Sample size
Target
Accrual to date
Final
250
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Maroochydore
Recruitment hospital [2] 0 0
Local Institution - Woodville
Recruitment hospital [3] 0 0
Local Institution - Camberwell
Recruitment hospital [4] 0 0
Local Institution - Nedlands
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
3124 - Camberwell
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Caba
Country [16] 0 0
Argentina
State/province [16] 0 0
Cordoba
Country [17] 0 0
Brazil
State/province [17] 0 0
Bahia
Country [18] 0 0
Brazil
State/province [18] 0 0
ES
Country [19] 0 0
Brazil
State/province [19] 0 0
RIO Grande DO SUL
Country [20] 0 0
Brazil
State/province [20] 0 0
Sao Paulo
Country [21] 0 0
Czechia
State/province [21] 0 0
Brno
Country [22] 0 0
France
State/province [22] 0 0
Bordeaux
Country [23] 0 0
France
State/province [23] 0 0
Le Kremlin Bicetre Cedex
Country [24] 0 0
France
State/province [24] 0 0
Marseille
Country [25] 0 0
France
State/province [25] 0 0
Montpellier Cedex 5
Country [26] 0 0
France
State/province [26] 0 0
Paris Cedex 10
Country [27] 0 0
France
State/province [27] 0 0
Strasbourg
Country [28] 0 0
Germany
State/province [28] 0 0
Freiburg
Country [29] 0 0
Germany
State/province [29] 0 0
Hannover
Country [30] 0 0
Germany
State/province [30] 0 0
Wuppertal
Country [31] 0 0
Italy
State/province [31] 0 0
Milano
Country [32] 0 0
Italy
State/province [32] 0 0
Udine
Country [33] 0 0
Japan
State/province [33] 0 0
Aichi
Country [34] 0 0
Japan
State/province [34] 0 0
Fukuoka
Country [35] 0 0
Japan
State/province [35] 0 0
Hokkaido
Country [36] 0 0
Japan
State/province [36] 0 0
Hyogo
Country [37] 0 0
Japan
State/province [37] 0 0
Ibaraki
Country [38] 0 0
Japan
State/province [38] 0 0
Kyoto
Country [39] 0 0
Japan
State/province [39] 0 0
Miyagi
Country [40] 0 0
Japan
State/province [40] 0 0
Nagasaki
Country [41] 0 0
Japan
State/province [41] 0 0
Okayama
Country [42] 0 0
Japan
State/province [42] 0 0
Shizuoka
Country [43] 0 0
Japan
State/province [43] 0 0
Tokyo
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Daegu
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Gwangju
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Seoul
Country [47] 0 0
Mexico
State/province [47] 0 0
Guanajuato
Country [48] 0 0
Mexico
State/province [48] 0 0
Nuevo LEON
Country [49] 0 0
Mexico
State/province [49] 0 0
Distrito Federal
Country [50] 0 0
Mexico
State/province [50] 0 0
San Luis Potosi
Country [51] 0 0
Puerto Rico
State/province [51] 0 0
San Juan
Country [52] 0 0
Sweden
State/province [52] 0 0
Solna
Country [53] 0 0
Sweden
State/province [53] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02915159