A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syn… (NCT02915159) | Clinical Trial Compass
CompletedPhase 3
A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome
United States, Argentina, Australia250 participantsStarted 2016-12-06
Plain-language summary
The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in patients with Sjögren's Syndrome.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested abatacept specifically for primary Sjögren's syndrome and measured disease activity using a scoring tool called the ESSDAI — can you tell me what the results showed, and whether abatacept actually reduced disease activity scores compared to placebo?
2Since this was a Phase 3 trial that has now completed, does that mean there's enough evidence about abatacept's safety and effectiveness in Sjögren's syndrome for us to seriously consider it as a treatment option for me?
3Abatacept is a medication that works by suppressing part of the immune system — given my specific health history, what safety risks should I be aware of if we were to discuss this as a possible treatment?
4Are there standard treatments for primary Sjögren's syndrome that I should try first before considering something like abatacept, or does my level of disease activity make a biologic like this worth discussing sooner?
5Since this trial focused on adults with active primary Sjögren's syndrome, how would you assess whether my own disease activity level is similar to the patients who were enrolled, and does that affect whether abatacept might be relevant for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)