Clinical trial NCT06945666: A Study of Iguratimod in Combination With Tofacitinib in RA Patients
Official title: A Multicenter Prospective Study of Iguratimod in Combination With Tofacitinib in Patients With Rheumatoid Arthritis With Poor Response to Conventional or Biological DMARDs
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Rheumatoid Arthritis (RA
Keywords: iguratimod
tofacitinib
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 will be conducted simultaneously at 8 research centers, and each center will strictly follow the unified research protocol and standard operating procedures.

Researchers are not allowed to interfere with the treatment of patients. The treatment and follow-up arrangements are determined by the prescribing doctor based on the actual clinical situation. Enrolled patients receive standard-dose treatment with aramodine combined with tofacitinib. The recommended dose of iguratimod is 25mg twice a day, and the recommended dose of tofacitinib is 5mg twice a day. During the treatment period, other background treatment drugs (decided by the prescribing doctor) are allowed, but other anti-rheumatic drugs that may affect the research results are not allowed, in order to simulate the real clinical diagnosis and treatment environment to the greatest extent and ensure the extrapolation of the research results.

The observation period was from the time of patient enrollment to 24 weeks after the end of treatment. For patients who experienced serious adverse events (SAEs), follow-up was conducted until the outcome was clear or the study was terminated. During the study, the patients' disease conditions, adverse drug reactions, and other situations were closely monitored. At each follow-up visit, the researchers would record the patients' symptoms and signs in detail, conduct relevant laboratory tests and necessary imaging examinations, and comprehensively assess the patients' disease status and treatment effects.

This study adopts a parallel controlled design, setting up a combined treatment group without an additional control group. The focus is on evaluating the efficacy and safety of the combined treatment plan in the target patient population. Through multi-center collaboration, data from patients with different characteristics in various regions will be extensively collected to enhance the representativeness and reliability of the research results. Meanwhile, to ensure the quality of the research data, a complete data management and quality control system will be established. Regular audits and evaluations of the data from each center will be conducted to promptly identify and correct any issues in the data.

Eligibility criteria: 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 outcomes:
measure: ACR20 (%)
timeFrame: 12 and 24 weeks of treatment
measure: ACR50 (%)
timeFrame: 12 and 24 weeks of treatment
measure: ACR70 (%)
timeFrame: 12 and 24 weeks of treatment
measure: DAS28
timeFrame: 12 and 24 weeks of treatment
Secondary outcomes:
measure: ESR (mm/h)
timeFrame: 4, 8, 12, and 24 weeks of treatment
measure: CRP (mg/L)
timeFrame: 4, 8, 12, and 24 weeks of treatment
measure: RF (IU/L)
timeFrame: 4, 8, 12, and 24 weeks of treatment
measure: CCP (U/L)
timeFrame: 4, 8, 12, and 24 weeks of treatment
measure: AE
timeFrame: From baseline to 24 weeks of treatment
Other outcomes:
Locations:
city: Yiwu
country: China
facility: 4th Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: