Combined therapy of Iguratimod and tofacitinib: This study aims to evaluate the efficacy and safety of the combination of iguratimod and tofacitinib in the treatment of RA patients with poor responses to traditional or biological DMARDs, providing evidence-based support for clinical treatment.
Study 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 quality of life and lifespan of patients. Currently, the treatment of RA adopts a target attainment strategy, aiming to control the disease and reduce the disability rate. Although traditional disease-modifying antirheumatic drugs (DMARDs) can alleviate symptoms, they have slow onset, many side effects, and cannot completely stop the disease progression. Among biological DMARDs (bDMARDs), tumor necrosis factor-α (TNF-α) inhibitors have better effects, but some patients have poor responses and their conditions are not effectively controlled, thus new treatment options are urgently needed. This study aims to evaluate the efficacy and safety of the combination of iguratimod and tofacitinib in the treatment of RA patients with poor responses to traditional or biological DMARDs, providing evidence-based support for clinical treatment.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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.
Primary outcome measure(s)
ACR20 (%) — 12 and 24 weeks of treatment American College of Rheumatology 20% improvement criteria (ACR20) response rates(Expressed as a percentage value) at 12 and 24 weeks of treatment.
ACR50 (%) — 12 and 24 weeks of treatment American College of Rheumatology 50% improvement criteria (ACR50) response rates(Expressed as a percentage value) at 12 and 24 weeks of treatment.
ACR70 (%) — 12 and 24 weeks of treatment American College of Rheumatology 70% improvement criteria (ACR70) response rates(Expressed as a percentage value) at 12 and 24 weeks of treatment.
DAS28 — 12 and 24 weeks of treatment Changes in disease activity score (DAS28) from baseline at 12 and 24 weeks of treatment. This score has no unit of measure.
Trial sites (1)
Facility
City
Region
Status
4th Affiliated Hospital, School of Medicine, Zhejiang University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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