Status:
NOT_YET_RECRUITING
A Study of Iguratimod in Combination With Tofacitinib in RA Patients
Lead Sponsor:
Jie Chang
Conditions:
Rheumatoid Arthritis (RA
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Rheumatoid arthritis (RA) is a common chronic inflammatory autoimmune disease characterized by synovitis, which can cause joint pain, deformity, and extra-articular symptoms, seriously affecting the q...
Detailed Description
This protocol is a multicenter, prospective study on the treatment of RA patients with poor response to conventional or biological DMARDs using a combination of iguratimod and tofacitinib. The study w...
Eligibility Criteria
Inclusion
- Age ≥18 years old, male or female.
- Meets the classification criteria for rheumatoid arthritis established by the American College of Rheumatology (ACR) and the European League against Rheumatism (EULAR) in 2010.
- Meeting any of the following treatment conditions with poor efficacy (DAS28 score as moderate-high disease activity) : receiving conventional DMARDs therapy such as methotrexate for at least 3 months; Treatment with biological agents such as TNFi for at least 3 months; Treatment with eramode or tofaciib alone for at least 3 months.
- Understand the procedure and content of the test, and voluntarily sign the informed consent.
Exclusion
- Patients with a known allergy to Iguratimod or tofacitinib.
- Patients who have previously used eramode or tofaciib and discontinued treatment for safety reasons;
- At the time of screening, they are in the acute phase of acute infection or chronic infection;
- At screening, hepatitis B DNA and/or hepatitis C RNA screening is positive, indicating viral hepatitis, HBs only Ag-positive healthy carriers were not considered as exclusion criteria, and inclusion of the patient was determined by the investigator;
- At the time of screening, have a history of active TB or TB screening suggests latent infection with mycobacterium tuberculosis;
- A medical condition or history of congestive heart failure at the time of screening;
- Include other ongoing projects or studies;
- Severe, progressive, uncontrolled disorders of vital organs and systems, as well as other medical conditions Any circumstances that should not be included in this collection.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06945666
Start Date
August 1 2025
End Date
May 31 2027
Last Update
April 25 2025
Active Locations (1)
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1
4th Affiliated Hospital, School of Medicine, Zhejiang University
Yiwu, Zhejiang, China, 322000