Study of Iguratimod in Sjögren's Syndrome

Phase 1

• Conditions: Sjogren's Syndrome
• Interventions: Drug: Iguratimod

• Registration Number: NCT03023592
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Study Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-01-15
• Study First Submitted QC: 2017-01-15
• Last Update Submitted: 2017-01-15
• Study First Posted: 2017-01-18
• Last Update Posted: 2017-01-18
• Study Start: 2017-02
• Primary Completion: 2018-02
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• A diagnosis of Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria
• Positive dry eyes and (or) dry mouth symptoms
• Hyperglobulinemia

Exclusion Criteria

• Complicated with other systemic autoimmune diseases
• Severe complications of Sjogren's syndrome
• Glucocorticosteroid therapy, systemic immunosuppressant therapy, or biological agents therapy within 3 months prior to the screening visit
• Active infections or chronic infectious diseases
• A history of malignancies
• Pregnancy or breathfeeding
• Inability to comply with the study protocol for any other reason

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iguratimod	Iguratimod	Patients are treated with Iguratimod 25 mg Twice a day for 24 weeks.

Primary Outcome Measures

Name	Time	Method
ESSDAI improvement	week 24	The change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score at 24 weeks.
ESSPRI improvement	week 24	The change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score at 24 weeks.

Secondary Outcome Measures

Name	Time	Method
SF-36	week 24	The change from baseline in SF-36 score at 24 weeks.
HAQ	week 24	The change from baseline in HAQ score at 24 weeks.
Unstimulated salivary flow rate	week 24	The change from baseline in unstimulated salivary flow rate at 24 weeks.
Rheumatoid Factors	week 24	The change from baseline in titer of rheumatoid factors at 24 weeks.
Schimer's test	week 24	The change from baseline in Schimer's test at 24 weeks.
Immunoglobulins	week 24	The change from baseline in IgG, IgM and IgA levels at 24 weeks.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China