At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 250 enrolled
Drug / intervention
Abatacept +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Abatacept and Placebo for Sjogrens Disease. Completed, enrolled 250 participants across 71 sites in 13 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in patients with Sjögren's Syndrome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSjogrens Disease
CountriesArgentina, Australia, Brazil, Czechia, France, Germany, Italy, Japan, Mexico, Puerto Rico, South Korea, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 2016
Enrollment StartDec 2016
Primary CompletionAug 2018
Study CompletionJul 2019
TodayJul 2026
First PostedSep 26, 2016
Enrollment StartDec 6, 2016
Primary CompletionAug 7, 2018
Study CompletionJul 23, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.8 years ago
Interventions
Abataceptbiological
Placeboother