Study of Iguratimod in Sjögren's Syndrome

Sjogren's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03023592
• Other study ID #: PUMCH170115
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 15, 2017
• Last updated: January 15, 2017
• Start date: February 2017
• Est. completion date: April 2018

Study information

• Verified date: January 2017
• Source: Peking Union Medical College Hospital
• Contact: Hua Chen, Dr.
• Phone: 86-10-69158797
• Email: chenhua[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• Iguratimod
Iguratimod 25 mg orally twice a day for 24 weeks

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ESSDAI improvement	The change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score at 24 weeks.	week 24
Primary	ESSPRI improvement	The change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score at 24 weeks.	week 24
Secondary	Unstimulated salivary flow rate	The change from baseline in unstimulated salivary flow rate at 24 weeks.	week 24
Secondary	Schimer's test	The change from baseline in Schimer's test at 24 weeks.	week 24
Secondary	SF-36	The change from baseline in SF-36 score at 24 weeks.	week 24
Secondary	HAQ	The change from baseline in HAQ score at 24 weeks.	week 24
Secondary	Immunoglobulins	The change from baseline in IgG, IgM and IgA levels at 24 weeks.	week 24
Secondary	Rheumatoid Factors	The change from baseline in titer of rheumatoid factors at 24 weeks.	week 24