A Study of Iguratimod in Combination With Tofacitinib in RA Patients

Sponsor
Jie Chang
Study ID
NCT06945666
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Rheumatoid Arthritis (RA

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Combined therapy of Iguratimod and tofacitinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Apr 2025
Primary completion
Jan 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: treatment group
    This study adopted a parallel controlled design, setting up a combined treatment group without an additional control group. The patients in the group received treatment with the standard dose of Iguratimod combined with tofacitinib. The recommended dose of Iguratimod is 25mg bid and that of tofacitinib is 5mg bid. During the treatment, other background therapeutic drugs were allowed to be used (determined by the prescribers), but other anti-rheumatic drugs that affected the study results were not allowed.

Primary Outcome Measure

ACR20 (%) [ Time Frame: 12 and 24 weeks of treatment ]

Central Contacts

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