Study of Iguratimod in Sjögren's Syndrome

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Sjogren's Syndrome

Treatments: Drug: Iguratimod

Study type: Interventional

Funder types: Other

Identifiers

NCT03023592

PUMCH170115

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Iguratimod

Experimental group

Description:

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

Treatment:

Drug: Iguratimod