NCT03023592

Study of Iguratimod in Sjögren's Syndrome

A Preliminary Efficacy Study of Iguratimod in Patients With Sjögren's Syndrome

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A single-center, self-control, open-label study of efficacy and safety of Iguratimod in patients with Sjögren's Syndrome

Detailed description

In this study, patients with Sjögren's Syndrome are enrolled and received Iguratimod 25 mg twice a day for 24 weeks. The differences of ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score, ESSPRI(EULAR Sjogren's Syndrome Patient Reported Index) score, unstimulated salivary flow rate, Schirmer's test SF-36 score and HAQ score between baseline and week 24 are evaluated to determine the efficacy of Iguratimod in patients with Sjögren's Syndrome.

Conditions

• Sjogren's Syndrome

Interventions

Type	Name	Description
DRUG	Iguratimod	Iguratimod 25 mg orally twice a day for 24 weeks

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-02-01
• Completion: 2018-04-01
• First posted: 2017-01-18
• Last updated: 2017-01-18

Locations

1 site across 1 country: China