Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-01 @ 8:44 PM
Study NCT ID:
NCT06945666
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-25
First Post:
2025-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Iguratimod in Combination With Tofacitinib in RA Patients
Sponsor:
Jie Chang
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: