- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04981145
The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome
March 23, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
78
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jing Xue
- Phone Number: 13858121751
- Email: xuej@zju.edu.cn
Study Locations
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IGU Group
|
Participants are treated with Iguratimod Tablets 25 mg Twice a day for 24 weeks.
|
Active Comparator: HCQ Group
|
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
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
|
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
Time Frame: 24 weeks
|
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
Time Frame: 24 weeks
|
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
Time Frame: 24 weeks
|
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
Time Frame: 10 and 24 weeks
|
The change from baseline in IgG concentration at 10 and 24 weeks.
|
10 and 24 weeks
|
Change in serum complements C3 and C4 concentration
Time Frame: 10 and 24 weeks
|
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
Time Frame: 10 and 24 weeks
|
The change from baseline in titer of rheumatoid factors at 10 and 24 weeks.
|
10 and 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yongmei Han, Sir Run Run Shaw Hospital
- Principal Investigator: Hongzhi Wang, First Affiliated Hospital of Jiaxing University
- Principal Investigator: Ying Guan, Zhuji People's hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 14, 2022
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
July 1, 2023
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)
April 4, 2022
Last Update Submitted That Met QC Criteria
March 23, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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