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

The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome: a Multi-center, Prospective, Open Study

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

Study Overview

• Status: Recruiting
• Conditions: Primary Sjögren's Syndrome
• Intervention / Treatment: Drug: Iguratimod Tablets; Drug: Hydroxychloroquine Sulfate Tablets

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jing Xue; Phone Number: 13858121751; Email: xuej@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Second affiliated hospital of zhejiang university，school of medical
      • Contact: Jing Xue; Phone Number: 13858121751; Email: jingxue@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IGU Group	Drug: Iguratimod Tablets; Participants are treated with Iguratimod Tablets 25 mg Twice a day for 24 weeks.
Active Comparator: HCQ Group	Drug: Hydroxychloroquine Sulfate Tablets; Participants are treated with Hydroxychloroquine Sulfate Tablets 200 mg Twice a day for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in The European League Against Rheumatism (EULAR) Sjogren's Syndrome Patient Reported Index (ESSPRI) score from Baseline to Week 24	The ESSPRI is composed of 3 scales - dryness, fatigue, and pain. Each scale is measured 0 - 10, 0 being no symptoms, 10 being maximal imaginable dryness, fatigue or pain. The total score is the mean score of the three scales. Baseline ESSPRI total score will be compared to week 24, end of treatment, ESSPRI total score.	24 weeks
Change in total score of the EULAR Sjogren's syndrome disease activity index (ESSDAI) from baseline to week 24	The ESSDAI is a disease activity measurement that has 12 domains. The score of each domain is the product of the weight of the domain by the level of activity. Activity levels are 0 - 3, 0 being no activity, 3 being high activity. The total score is the sum of the score of all domains. Change in total score from BL to week 24 will be measured.	24 weeks
Change in Schimer's test	The change from baseline in Schimer's test at 24 weeks. The Schirmer's test assesses tear secretion.	24 weeks
Change in Immunoglobulin G (IgG) concentration	The change from baseline in IgG concentration at 10 and 24 weeks.	10 and 24 weeks
Change in serum complements C3 and C4 concentration	The change from baseline in serum complements C3 and C4 concentrationat 10 and 24 weeks.	10 and 24 weeks
Change in titer of Rheumatoid Factors	The change from baseline in titer of rheumatoid factors at 10 and 24 weeks.	10 and 24 weeks

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Yongmei Han, Sir Run Run Shaw Hospital; Principal Investigator: Ying Guan, Zhuji People's Hospital; Principal Investigator: Hongzhi Wang, Affiliated Hospital of Jiaxing University

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 17, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Sjögren's syndrome; Iguratimod; Primary Sjögren's syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Hydroxychloroquine
• Other Study ID Numbers: 2021-0391

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No