Study of Iguratimod in Sjögren's Syndrome

Peking Union Medical College Hospital30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sjogren's Syndrome

Interventions

IguratimodDRUG

Iguratimod 25 mg orally twice a day for 24 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

ESSDAI improvement

The change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score at 24 weeks.

Time frame: week 24

ESSPRI improvement

The change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score at 24 weeks.

Time frame: week 24

Secondary Outcomes

Unstimulated salivary flow rate

The change from baseline in unstimulated salivary flow rate at 24 weeks.

Time frame: week 24

Schimer's test

The change from baseline in Schimer's test at 24 weeks.

Time frame: week 24

SF-36

The change from baseline in SF-36 score at 24 weeks.

Time frame: week 24

HAQ

The change from baseline in HAQ score at 24 weeks.

Time frame: week 24

Immunoglobulins

The change from baseline in IgG, IgM and IgA levels at 24 weeks.

Time frame: week 24

Rheumatoid Factors

The change from baseline in titer of rheumatoid factors at 24 weeks.

Time frame: week 24

Central Contacts

Hua Chen, Dr.

CONTACT

86-10-69158797 chenhua@pumch.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.