Study of Iguratimod in Sjögren's Syndrome

NCT03023592 | Unknown Phase 1 DMC

• 1 other identifier: PUMCH170115
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sjogren's Syndrome

Keywords

Sjogren's Syndrome; Iguratimod

Outcome Measures

Primary Outcomes (2)

• ESSDAI improvement

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

  week 24

• ESSPRI improvement

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

  week 24

Secondary Outcomes (6)

• Unstimulated salivary flow rate

  week 24

• Schimer's test

  week 24

• SF-36

  week 24

• HAQ

  week 24

• Immunoglobulins

  week 24

Study Arms (1)

Iguratimod

EXPERIMENTAL

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

Drug: Iguratimod

Interventions

Iguratimod DRUG

Iguratimod 25 mg orally twice a day for 24 weeks

Also known as: T-614

Iguratimod

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

iguratimod; T 614

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yan Zhao, Dr.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Chen, Dr.

CONTACT

86-10-69158797; chenhua@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2017
• First Posted: January 18, 2017
• Study Start: February 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: April 1, 2018
• Last Updated: January 18, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)