drugset / Trial / NCT06945666

A Study of Iguratimod in Combination With Tofacitinib in RA Patients

NCT06945666

Phase 4 Not yet recruiting 200 enrolled Jie Chang
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-08-01
Primary completion
2027-01-31
Completion
2027-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Iguratimod Small molecule 25 mg
Subject Tofacitinib Small molecule 5 mg

Indications