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

NCT04981145 | Recruiting Phase 4

• 1 other identifier: 2021-0391
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Primary Sjögren's syndrome; Sjögren's syndrome; Iguratimod

Outcome Measures

Primary Outcomes (1)

• The change of SSRI-30 between the two groups at 24 weeks

  SS Responder Index (SSRI) is a composite endpoint, investigators defined an SSRI-30 response as a ≥30% improvement in at least two of five outcome measures (patient-assessed visual analogue scale scores for fatigue, oral dryness and ocular dryness, unstimulated whole salivary flow and ESR at 24 weeks

  24 weeks

Secondary Outcomes (6)

• Change in The European League Against Rheumatism (EULAR) Sjogren's Syndrome Patient Reported Index (ESSPRI) score from Baseline to Week 24

  24 weeks

• Change in total score of the EULAR Sjogren's syndrome disease activity index (ESSDAI) from baseline to week 24

  24 weeks

• Change in Schimer's test

  24 weeks

• Change in Immunoglobulin G (IgG) concentration

  10 and 24 weeks

• Change in serum complements C3 and C4 concentration

  10 and 24 weeks

Study Arms (2)

IGU Group

EXPERIMENTAL

Drug: Iguratimod Tablets

HCQ Group

ACTIVE COMPARATOR

Drug: Hydroxychloroquine Sulfate Tablets

Interventions

Iguratimod Tablets DRUG

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

IGU Group

Hydroxychloroquine Sulfate Tablets DRUG

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

HCQ Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with pSS by meeting the 2016 ACR/EULAR Classification Criteria.
• The patient complained of dry mouth and eyes.
• Positive anti-SSA/Ro-60 antibody at screening.
• IgG≥16 g/L.
• No hormone, immunosuppressant, biological agents or other treatments were received within 4 weeks before screening;
• Pregnancy test of is negative. Use effective contraceptives during the trial (female)
• Those who did not participate in any drug trial within 12 weeks before enrollment

You may not qualify if:

• Pregnant or lactating or planning to get pregnant during the duration of the study.
• Complicated with other CTD
• Complicated with malignancy
• mental illness, a history of alcohol abuse, immunodeficiency, uncontrolled infections, and drug or other substance abuse
• serious systemic damage, glucocorticoids, other immunosuppressants and biological agents should be added to control the condition: Heart, liver (transaminase/bilirubin \>1.5 times the upper normal limit), kidney (Cr≥133mmol/L), lung (FVC % \< 60%), blood (white blood cell \<3×109/L, HGB\<80g/L, PLT\<80×109/L), etc.
• Fundus/visual field lesions;
• Allergic to any component of the study drug (IGU and/or HCQ);
• the investigator considers the patient to be unsuitable for entry into the study

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second affiliated hospital of zhejiang university，school of medical

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

• Chen X, Zhang T, Meng L, Xu C, Jiang L, Wang G, Hou T, Wang H, Han Y, Guan Y, Wang Y, Xue J. Efficacy and safety of iguratimod in patients with primary Sjogren's syndrome: a multicentre randomised controlled trial. RMD Open. 2025 Dec 21;11(4):e006180. doi: 10.1136/rmdopen-2025-006180.

  PMID: 41423293 DERIVED

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

iguratimod; Hydroxychloroquine

Condition Hierarchy (Ancestors)

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; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yongmei Han

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

• Hongzhi Wang

  Affiliated Hospital of Jiaxing University

  PRINCIPAL INVESTIGATOR

• Ying Guan

  Zhuji People's hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Xue

CONTACT

13858121751; xuej@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 28, 2021
• Study Start: January 14, 2022
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)