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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03023592 |
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Date of registration:
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15/01/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of Iguratimod in Sjögren's Syndrome
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Scientific title:
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A Preliminary Efficacy Study of Iguratimod in Patients With Sjögren's Syndrome |
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Date of first enrolment:
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February 2017 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03023592 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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China
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Contacts
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Name:
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Hua Chen, Dr. |
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Address:
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Telephone:
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86-10-69158797 |
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Email:
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chenhua@pumch.cn |
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Affiliation:
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Name:
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Hua Chen, Dr. |
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Address:
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Telephone:
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86-10-69158797 |
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Email:
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chenhua@pumch.cn |
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Affiliation:
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Name:
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Yan Zhao, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Peking Union Medical College Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sjogren's Syndrome
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Intervention(s)
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Drug: Iguratimod
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Primary Outcome(s)
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ESSDAI improvement
[Time Frame: week 24]
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ESSPRI improvement
[Time Frame: week 24]
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Secondary Outcome(s)
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Schimer's test
[Time Frame: week 24]
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Unstimulated salivary flow rate
[Time Frame: week 24]
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SF-36
[Time Frame: week 24]
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HAQ
[Time Frame: week 24]
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Immunoglobulins
[Time Frame: week 24]
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Rheumatoid Factors
[Time Frame: week 24]
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Secondary ID(s)
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PUMCH170115
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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