NCT06945666Not yet recruitingPhase 4
A Study of Iguratimod in Combination With Tofacitinib in RA Patients
A Multicenter Prospective Study of Iguratimod in Combination With Tofacitinib in Patients With Rheumatoid Arthritis With Poor Response to Conventional or Biological DMARDs
Source: ClinicalTrials.gov · Last updated 25 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 2 Apr 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Jie Chang
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06945666
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- From 1 Aug 2025 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously used eramode or tofaciib and discontinued treatment for safety reasons;
Other illness
- 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.
Other
- Include other ongoing projects or studies;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 4th Affiliated Hospital, School of Medicine, Zhejiang University Coordinator of this site? Confirm its status | Yiwu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.