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RecruitingNCT04981145Updated Oct 16, 2024

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

A Phase 4 interventional study of Iguratimod Tablets and Hydroxychloroquine Sulfate Tablets in Primary Sjögren's Syndrome, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-16.

Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2022; still recruiting 4 years 9 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Primary Sjögren's Syndrome

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Keywords

  • Primary Sjögren's syndrome
  • Sjögren's syndrome
  • Iguratimod
03

In context

Sjogren's Syndrome

381 studies on the registry are indexed under Sjogren's Syndrome; 106 are open to participants now.

This study's planned enrollment of 78 is above the median of 50 across 250 interventional studies indexed under Sjogren's Syndrome.

Browse Sjogren's Syndrome studies →

Lead sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 90 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
78 participants (estimated)

Study arms

  • Experimental
    IGU Group

    Drug: Iguratimod Tablets

  • Active comparator
    HCQ Group

    Drug: Hydroxychloroquine Sulfate Tablets

Interventions

06

What researchers measure

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

    Time frame: 24 weeks

Secondary outcomes

  1. 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.

    Time frame: 24 weeks

  2. 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.

    Time frame: 24 weeks

  3. Change in Schimer's test

    The change from baseline in Schimer's test at 24 weeks. The Schirmer's test assesses tear secretion.

    Time frame: 24 weeks

  4. Change in Immunoglobulin G (IgG) concentration

    The change from baseline in IgG concentration at 10 and 24 weeks.

    Time frame: 10 and 24 weeks

  5. Change in serum complements C3 and C4 concentration

    The change from baseline in serum complements C3 and C4 concentrationat 10 and 24 weeks.

    Time frame: 10 and 24 weeks

  6. Change in titer of Rheumatoid Factors

    The change from baseline in titer of rheumatoid factors at 10 and 24 weeks.

    Time frame: 10 and 24 weeks

07

Study locations

1 of 1 sites recruiting
  • Second affiliated hospital of zhejiang university，school of medical
    Hangzhou, Zhejiang 310000, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 41423293 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2022 (actual). Primary completion is estimated for Dec 2024, 35 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 5, 2021
First posted
Jul 28, 2021
StartActual
Jan 14, 2022
Primary completionEst.
Dec 2024
CompletionEst.
Jul 2025
Last update
Oct 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04981145
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Responsible party
Sponsor
First posted
Jul 28, 2021
Start date
Jan 14, 2022
Primary completion
Dec 2024 (estimated)
Completion
Jul 2025 (estimated)
Last update
Oct 16, 2024

Study contacts

Jing Xue
Contact
xuej@zju.edu.cn
13858121751
Yongmei Han
principal investigator · Sir Run Run Shaw Hospital
Hongzhi Wang
principal investigator · Affiliated Hospital of Jiaxing University
Ying Guan
principal investigator · Zhuji People's Hospital of Zhejiang Province

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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