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Tests treatment safety and results for Primary Sjögren's Syndrome
Official title The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome
ClinicalTrials.gov ID: NCT04981145
What this study is testing
What is Iguratimod Tablets?
Iguratimod Tablets is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for primary sjögren's syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A multi-center, prospective, open-label, randomized controlled study of efficacy and safety of Iguratimod in patients with Primary Sjögren's syndrome
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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;
You likely can't join if
- 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...
- Fundus/visual field lesions;
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.