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

Primary Sjögren's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04981145
• Other study ID #: 2021-0391
• Status: Recruiting
• Phase: Phase 4
• Start date: January 14, 2022
• Est. completion date: July 2023

Study information

• Verified date: March 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jing Xue
• Phone: 13858121751
• Email: xuej[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: July 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Primary Sjögren's Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• Iguratimod Tablets
Participants are treated with Iguratimod Tablets 25 mg Twice a day for 24 weeks.
• Hydroxychloroquine Sulfate Tablets
Participants are treated with Hydroxychloroquine Sulfate Tablets 200 mg Twice a day for 24 weeks.

Locations

Country	Name	City	State
China	Second affiliated hospital of zhejiang university,school of medical	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in Immunoglobulin G (IgG) concentration	The change from baseline in IgG concentration at 10 and 24 weeks.	10 and 24 weeks
Secondary	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
Secondary	Change in titer of Rheumatoid Factors	The change from baseline in titer of rheumatoid factors at 10 and 24 weeks.	10 and 24 weeks