Study of Iguratimod in Sjögren's Syndrome

NCT ID: NCT03023592

Last Updated: 2017-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-28

Study Completion Date

2018-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Sjogren's Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iguratimod

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

Group Type EXPERIMENTAL

Iguratimod

Intervention Type DRUG

Iguratimod 25 mg orally twice a day for 24 weeks

Interventions

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Iguratimod

Iguratimod 25 mg orally twice a day for 24 weeks

Intervention Type DRUG

Other Intervention Names

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T-614

Eligibility 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Zhao, Dr.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hua Chen, Dr.

Role: CONTACT

86-10-69158797

Facility Contacts

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Hua Chen, Dr.

Role: primary

86-10-69158797

Other Identifiers

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PUMCH170115

Identifier Type: -

Identifier Source: org_study_id

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