Overview

Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome

Status:
Completed
Trial end date:
2019-08-01
Target enrollment:
Participant gender:
Summary
Primary Sjögren's syndrome (pSS) is a common chronic auto-immune disease, characterised by inflammation of the exocrine glands, resulting in progressive dryness of the eyes and the mouth. Furthermore, many patients experience extraglandular symptoms such as restricting fatigue. Currently, biological agents have been introduced in various systemic autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus. No biological agent has yet been approved for the treatment of pSS. In an open-label study, we have shown that abatacept treatment of pSS patients has promising results (Meiners et al., 2014). Therefore, the aim of this study is to evaluate efficacy and safety of subcutaneous abatacept treatment in pSS in a larger and randomized clinical trial.
Phase:
Phase 3
Details
Lead Sponsor:
University Medical Center Groningen
Collaborator:
Bristol-Myers Squibb
Treatments:
Abatacept