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Study of Iguratimod in Sjögren's Syndrome

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03023592
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
13.9
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Preliminary Efficacy Study of Iguratimod in Patients With Sjögren's Syndrome
Study Start Date :
Feb 1, 2017
Anticipated Primary Completion Date :
Feb 1, 2018
Anticipated Study Completion Date :
Apr 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. ESSDAI improvement [week 24]

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

    2. ESSPRI improvement [week 24]

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

    Secondary Outcome Measures

    1. Unstimulated salivary flow rate [week 24]

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

    2. Schimer's test [week 24]

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

    3. SF-36 [week 24]

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

    4. HAQ [week 24]

      The change from baseline in HAQ score at 24 weeks.

    5. Immunoglobulins [week 24]

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

    6. Rheumatoid Factors [week 24]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing Beijing China 100730

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT03023592
    Other Study ID Numbers:
    • PUMCH170115
    First Posted:
    Jan 18, 2017
    Last Update Posted:
    Jan 18, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Peking Union Medical College Hospital
    Sjogren's Syndrome
    Iguratimod
    Additional relevant MeSH terms:
    Sjogren's Syndrome
    Syndrome

    Study Results

    No Results Posted as of Jan 18, 2017