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Study of Iguratimod in Sjögren's Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03023592
Recruitment Status : Unknown
Verified January 2017 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : January 18, 2017
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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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
Sjogren's Syndrome Drug: Iguratimod 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: T-614


Outcome Measures
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Primary Outcome Measures :
  1. ESSDAI improvement [ Time Frame: week 24 ]
    The change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score at 24 weeks.

  2. ESSPRI improvement [ Time Frame: 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 [ Time Frame: week 24 ]
    The change from baseline in unstimulated salivary flow rate at 24 weeks.

  2. Schimer's test [ Time Frame: week 24 ]
    The change from baseline in Schimer's test at 24 weeks.

  3. SF-36 [ Time Frame: week 24 ]
    The change from baseline in SF-36 score at 24 weeks.

  4. HAQ [ Time Frame: week 24 ]
    The change from baseline in HAQ score at 24 weeks.

  5. Immunoglobulins [ Time Frame: week 24 ]
    The change from baseline in IgG, IgM and IgA levels at 24 weeks.

  6. Rheumatoid Factors [ Time Frame: week 24 ]
    The change from baseline in titer of rheumatoid factors at 24 weeks.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023592


Contacts
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Contact: Hua Chen, Dr. 86-10-69158797 chenhua@pumch.cn

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Hua Chen, Dr.    86-10-69158797    chenhua@pumch.cn   
Principal Investigator: Yan Zhao, Dr.         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Yan Zhao, Dr. Peking Union Medical College Hospital
More Information
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03023592    
Other Study ID Numbers: PUMCH170115
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Peking Union Medical College Hospital:
Sjogren's Syndrome
Iguratimod
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
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
Autoimmune Diseases
Immune System Diseases