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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02915159
• Date of registration: 23/09/2016
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• 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
• Date of first enrolment: December 6, 2016
• Target sample size: 250
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02915159
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Brazil, Canada, Czech Republic, Czechia, France, Germany, Italy, Japan, Korea, Republic of, Mexico, Puerto Rico, Sweden, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sjogrens Disease

Intervention(s)

Biological: Abatacept

Other: Placebo

Primary Outcome(s)

Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) [Time Frame: Day 169]

Secondary Outcome(s)

Change From Baseline at All Measured Time Points in the ESSDAI [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]

Change From Baseline in Tear Break-up Time [Time Frame: Day 85, Day 169]

Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]

Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI) [Time Frame: Day 85, Day 169]

Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]

Change From Baseline in Numeric Rating Scale for Eye Dryness [Time Frame: Day 1, 29, 57, 85, 113, 141, 169]

Change From Baseline in Participant Assessment of Disease Activity [Time Frame: Day 29, 57, 85, 113, 141, 169]

Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]

Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]

Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]

Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]

Change From Baseline in the Stimulated Whole Salivary Flow [Time Frame: Day 169]

Change From Baseline in Physician Global Assessment of Disease Activity [Time Frame: Day 29, 57, 85, 113, 141, 169]

Geometric Mean of Trough Concentration (Cmin) of Abatacept [Time Frame: Day 29, 85, 113, 141, 169]

Laboratory Marked Abnormalities: Cumulative Abatacept Period [Time Frame: Day 365 and 3 months of follow up approximately 450 Days]

Laboratory Marked Abnormalities: Double Blind Period [Time Frame: Day 1 up to first dose of OL abatacept or up to 56 post last dose in double -blind for those not in OL.]

Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]

Summary of Adverse Events: Cumulative Abatacept Period [Time Frame: Day 365 and 3 months of follow up approximately 450 Days]

Summary of Adverse Events: Double Blind Period [Time Frame: 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.]

Change From Baseline at All Measured Time Points in the ESSPRI [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]

Change From Baseline in Numeric Rating Scale for Mouth Dryness [Time Frame: Day 1, 29, 57, 85, 113, 141, 169]

Change From Baseline in Schirmer's Test [Time Frame: Day 85, Day 169]

Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]

Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3 [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]

Change From Baseline in Components of ESSDAI [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169]

Change From Baseline in ESSPRI Components [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]

Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]

Change From Baseline in Patient Fatigue [Time Frame: Day 29, 57, 85, 113, 141, 169]

Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]

Change From Baseline in 36-item Short Form Health Survey (SF-36) [Time Frame: Day 85, Day 169]

Change From Baseline in Stimulated Salivary Flow [Time Frame: Day 85, Day 169]

Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI) [Time Frame: Day 169]

Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]

Percentage of Participants With a Positive Antibody Response in the Cumulative Abatacept Period [Time Frame: Day 365, post open label treatment day 85]

Change From Baseline in the Ocular Staining Score (OSS) [Time Frame: Day 85, Day 169]

Change From Baseline in Unstimulated Salivary Flow [Time Frame: Day 85, Day 169]

Percentage of Participants With a Positive Antibody Response [Time Frame: Day 85 db, day 169 db, post treatment day 85]

Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]

Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]

Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population [Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]

Secondary ID(s)

2016-001948-19

IM101-603

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02915159