Iguratimod Combined With Tofacitinib in the Treatment of Rheumatoid Arthritis
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria: Patients who meet the following inclusion criteria will be eligible to participate in the study: Male or female aged 18-65 years old; Weight not less than 40kg; Since the diagnosis of RA, the course of disease was ≥6 months; Patients who meet RA standards in 1987 and 2010 ; RA patients with moderate to high disease activity (DAS28 > 3.2) at the time of screening; 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); Poor response or intolerance to at least one DMARD, including csDMARDs, bDMARDs, but not tsDMARDs; Previous use of any JAK inhibitor was discontinued for six months before enrollment; For patients who have used DMARDs, the washout criteria must be met; 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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Double-Blind Iguratimod
Double-Blind Placebo
Iguratimod (25mg twice daily) combined with Tofacitinib (5mg twice daily) for 24 weeks (6 months)
Placebo (25mg twice daily) combined with Tofacitinib (5mg twice daily) for 24 weeks (6 months)