Study of Iguratimod in Sjögren's Syndrome

January 15, 2017 updated by: Peking Union Medical College Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Yan Zhao, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Iguratimod
Patients are treated with Iguratimod 25 mg Twice a day for 24 weeks.
Drug: Iguratimod
Iguratimod 25 mg orally twice a day for 24 weeks
Other Names:
  • T-614

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ESSDAI improvement
Time Frame: week 24
The change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score at 24 weeks.
week 24
ESSPRI improvement
Time Frame: week 24
The change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score at 24 weeks.
week 24

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Yan Zhao, Dr., Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2017

Primary Completion (ANTICIPATED)

February 1, 2018

Study Completion (ANTICIPATED)

April 1, 2018

Study Registration Dates

First Submitted

January 15, 2017

First Submitted That Met QC Criteria

January 15, 2017

First Posted (ESTIMATE)

January 18, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 15, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH170115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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