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

Primary Purpose

Primary Sjögren's Syndrome

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Iguratimod Tablets

Hydroxychloroquine Sulfate Tablets

About this trial

This is an interventional treatment trial for Primary Sjögren's Syndrome focused on measuring Primary Sjögren's syndrome, Sjögren's syndrome, Iguratimod

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Second affiliated hospital of zhejiang university，school of medicalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IGU Group

HCQ Group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

Change in Schimer's test

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

Change in Immunoglobulin G (IgG) concentration

The change from baseline in IgG concentration at 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.

Change in titer of Rheumatoid Factors

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

Full Information

NCT ID

NCT04981145

First Posted

July 5, 2021

Last Updated

March 23, 2022

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT04981145

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 14, 2022 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Sjögren's Syndrome

Keywords

Primary Sjögren's syndrome, Sjögren's syndrome, Iguratimod

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IGU Group

Arm Type

Experimental

Arm Title

HCQ Group

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Iguratimod Tablets

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Hydroxychloroquine Sulfate Tablets

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

24 weeks

Title

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

Description

Time Frame

24 weeks

Title

Change in Schimer's test

Description

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

Time Frame

24 weeks

Title

Change in Immunoglobulin G (IgG) concentration

Description

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

Time Frame

10 and 24 weeks

Title

Change in serum complements C3 and C4 concentration

Description

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

Time Frame

10 and 24 weeks

Title

Change in titer of Rheumatoid Factors

Description

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

Time Frame

10 and 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jing Xue

Phone

13858121751

xuej@zju.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yongmei Han

Organizational Affiliation

Sir Run Run Shaw Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hongzhi Wang

Organizational Affiliation

Affiliated Hospital of Jiaxing University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ying Guan

Organizational Affiliation

Zhuji People's hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Second affiliated hospital of zhejiang university，school of medical

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jing Xue

Phone

13858121751

jingxue@zju.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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