Tests iguratimod with tofacitinib in rheumatoid arthritis not helped by earlier drugs
Tests two drugs together in adults with rheumatoid arthritis who responded poorly to earlier treatment.
Plain-language title generated from the registry record
Registry title: A Study of Iguratimod in Combination With Tofacitinib in RA Patients
Key facts
- Where
- Yiwu, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06945666, who can take part
Where in China
- 4th Affiliated Hospital, School of Medicine, Zhejiang UniversityYiwu, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jie Chang
- Trial code
- NCT06945666
- Record updated
- 25 April 2025
- Original description
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.Read full original descriptionShow less
A Multicenter Prospective Study of Iguratimod in Combination With Tofacitinib in Patients With Rheumatoid Arthritis With Poor Response to Conventional or Biological DMARDs
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.
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 who have previously used eramode or tofaciib and discontinued treatment for safety reasons; Patients with a known allergy to Iguratimod or tofacitinib; 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; 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; Include other ongoing projects or studies.