NCT05087589

Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjogren's Syndrome

Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjögren's Syndrome:a Prospective Observational Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore the clinical and immunological efficacy of tofacitinib on primary Sjögren's Syndrome

Detailed description

The investigators designed a single center, open-label, prospective study. Adults with active primary Sjögren's Syndrome will be enrolled, meeting the American College of Rheumatology(ACR) \& European allance of associations for rheumatology(EULAR)(2016) diagnostic criteria . Tofacitinib 5 mg bd was administered for 6 months to explore its efficacy and safety. The improvement of clinical and laboratory indexes was evaluated. Changes of immune cell subsets and cytokines were monitored.

Conditions

• Primary Sjögren's Syndrome

Interventions

Type	Name	Description
DRUG	Tofacitinib	Tofacitinib 5mg was taken orally twice a day for 6 months

Timeline

• Start date: 2021-11-20
• Primary completion: 2023-01-01
• Completion: 2023-10-01
• First posted: 2021-10-21
• Last updated: 2022-03-02

Locations

1 site across 1 country: China