Primary Sjögren's SyndromePhase 4NCT04981145
The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome
A Phase 4 study testing Iguratimod Tablets and Hydroxychloroquine Sulfate Tablets in people with Primary Sjögren's Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
A multi-center, prospective, open-label, randomized controlled study of efficacy and safety of Iguratimod in patients with Primary Sjögren's syndrome Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Sjögren's Syndrome
- What is being tested?
- Iguratimod Tablets and Hydroxychloroquine Sulfate Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2022to Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second affiliated hospital of zhejiang university，school of medical
Hangzhou, Zhejiang, 310000
Jing Xue, 13858121751, jingxue@zju.edu.cn
About this study
Official title: 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
- Conditions
- Primary Sjögren's Syndrome
- Being tested
- Iguratimod Tablets, Hydroxychloroquine Sulfate Tablets
- Keywords
- Primary Sjögren's syndrome, Sjögren's syndrome, Iguratimod
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iguratimod TabletsDrug
Participants are treated with Iguratimod Tablets 25 mg Twice a day for 24 weeks.
Hydroxychloroquine Sulfate TabletsDrug
Participants are treated with Hydroxychloroquine Sulfate Tablets 200 mg Twice a day for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| IGU Group | Experimental | Not described Receives: Drug: Iguratimod Tablets |
| HCQ Group | Active comparator | Not described Receives: Drug: Hydroxychloroquine Sulfate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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.
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.
Measured: 24 weeks
Change in Immunoglobulin G (IgG) concentration
The change from baseline in IgG concentration at 10 and 24 weeks.
Measured: 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.
Measured: 10 and 24 weeks
Change in titer of Rheumatoid Factors
The change from baseline in titer of rheumatoid factors at 10 and 24 weeks.
Measured: 10 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start14 Jan 2022
- Primary completionDec 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongmei Han, Principal investigator, Sir Run Run Shaw HospitalHongzhi Wang, Principal investigator, Affiliated Hospital of Jiaxing UniversityYing Guan, Principal investigator, Zhuji People's Hospital of Zhejiang Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981145
- Sponsor's protocol ID
- 2021-0391
- Status last verified
- Oct 2024
- First submitted
- 5 Jul 2021
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome: a Multi-center, Prospective, Open Study
- ClinicalTrials.gov ID
- NCT04981145
- Acronym / sponsor ID
- 2021-0391
- Conditions
- Primary Sjögren's Syndrome
- Keywords
- Primary Sjögren's syndrome, Sjögren's syndrome, Iguratimod
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-center, prospective, open-label, randomized controlled study of efficacy and safety of Iguratimod in patients with Primary Sjögren's syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IGU Group | Experimental | Drug: Iguratimod Tablets |
| HCQ Group | Active comparator | Drug: Hydroxychloroquine Sulfate Tablets |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iguratimod TabletsParticipants are treated with Iguratimod Tablets 25 mg Twice a day for 24 weeks. | Drug | IGU Group |
| Hydroxychloroquine Sulfate TabletsParticipants are treated with Hydroxychloroquine Sulfate Tablets 200 mg Twice a day for 24 weeks. | Drug | HCQ Group |
Primary outcome
The change of SSRI-30 between the two groups at 24 weeks
Time frame: 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
6 secondary outcomes
Change in The European League Against Rheumatism (EULAR) Sjogren's Syndrome Patient Reported Index (ESSPRI) score from Baseline to Week 24
Time frame: 24 weeks
Change in total score of the EULAR Sjogren's syndrome disease activity index (ESSDAI) from baseline to week 24
Time frame: 24 weeks
Change in Schimer's test
Time frame: 24 weeks
Change in Immunoglobulin G (IgG) concentration
Time frame: 10 and 24 weeks
Change in serum complements C3 and C4 concentration
Time frame: 10 and 24 weeks
Change in titer of Rheumatoid Factors
Time frame: 10 and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 41423293Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iguratimod Tablets and Hydroxychloroquine Sulfate Tablets in people with Primary Sjögren's Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Xue (13858121751, xuej@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of SSRI-30 between the two groups at 24 weeks (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04981145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.