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The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome

NCT04981145 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-10-16

No results posted yet for this study

Summary

A multi-center, prospective, open-label, randomized controlled study of efficacy and safety of Iguratimod in patients with Primary Sjögren's syndrome

Conditions

  • Primary Sjögren's Syndrome

Interventions

DRUG

Iguratimod Tablets

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

DRUG

Hydroxychloroquine Sulfate Tablets

Participants are treated with Hydroxychloroquine Sulfate Tablets 200 mg Twice a day for 24 weeks.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Yongmei Han · Sir Run Run Shaw Hospital

  • Hongzhi Wang · Affiliated Hospital of Jiaxing University

  • Ying Guan · Zhuji People's hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-14
Primary Completion
2024-12-31
Completion
2025-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04981145 on ClinicalTrials.gov