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

NCT02067910 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-08-28

No results posted yet for this study

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.

Conditions

  • Sjögren's Syndrome

Interventions

DRUG

Abatacept SC

Weekly subcutaneous administration of 125 mg Abatacept

Sponsors & Collaborators

Principal Investigators

  • H. Bootsma, MD, PhD · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2019-02-28
Completion
2019-08-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02067910 on ClinicalTrials.gov