Iguratimod Combined With Tofacitinib in the Treatment of Rheumatoid Arthritis

• Status: Not yet recruiting
• Trial end date: 2025-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of Iguratimod combined with Tofacitinib in the treatment of csDMARD-IR patients with active moderate-to-severe rheumatoid arthritis

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Collaborator: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Treatments: Tofacitinib

Criteria

Inclusion Criteria:

Patients who meet the following inclusion criteria will be eligible to participate in the study:

1. Male or female aged 18-65 years old;

2. Weight not less than 40kg;

3. Since the diagnosis of RA, the course of disease was ≥6 months;

4. Patients who meet RA standards in 1987 and 2010 ;

5. RA patients with moderate to high disease activity (DAS28 > 3.2) at the time of screening;

6. Active RA (≥6 joints swelling [66 joints count]; ≥Tenderness of 6 joints [68 joint counts]; ESR>28 mm/h or C-reactive protein (CRP) >1.0 mg/dL);

7. Poor response or intolerance to at least one DMARD, including csDMARDs, bDMARDs, but not tsDMARDs;

8. Previous use of any JAK inhibitor was discontinued for six months before enrollment;

9. For patients who have used DMARDs, the washout criteria must be met;

10. Written informed consent;

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study:

• Pregnant or lactating women;

• Platelet count < 10^9/L, or white blood cell < 3*10^9/L, or absolute neutrophil count < 1.2*10^9/L, or Hemoglobin < 9 g/dL or hematocrit <30%;

• According to Cockcroft-Gault, the glomerular filtration rate was ≤40 ml/min.

• ALT>1.5×ULN, AST>1.5×ULN, Cr>135umol/L;

• Subjects with serious cardiovascular, renal, hematologic or endocrine diseases;

• A history of autoimmune rheumatic diseases other than Sjogren's syndrome;

• Subjects with uncontrolled infection;

• Subjects receiving live vaccines within 6 weeks prior to study entry;

• history of alcohol or drug abuse and abstinence for less than 6 months prior to the first use of the study drug;

• Subjects participating in other clinical study within 3 months prior to study entry;

• Have a history of malignant tumor;

• History of recurrent herpes zoster, diffuse herpes zoster;

• People who are allergic to any of the study drugs;

• Other conditions in which the investigator deemed the patient inappropriate for trial entry;