To evaluate the efficacy and safety of Kunxian Capsule combined with Methotrexate and Tofacitinib in the treatment of difficult-to-treat rheumatoid arthritis through a multicenter, randomized, double-blind, placebo-controlled clinical trial, and to identify the therapeutic advantages of integrated Chinese and Western medicine for optimizing the clinical strategy of D2T RA.
Fully understand the purpose and requirements of the trial, voluntarily participate by signing written informed consent, and be willing and able to complete the study procedures, including medication administration and follow-up assessments;
Male patients aged ≥50 years with no fertility requirements, or postmenopausal female patients, younger than 70 years;
Patients diagnosed with rheumatoid arthritis (RA) according to the 1987 revised criteria of the American College of Rheumatology (ACR), or the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria;
Primary symptoms: joint pain and swelling with a wandering nature; joint pain and swelling with intermittent occurrence.
Suspected or confirmed allergy to the investigational drug (including excipients or drugs of the same class), or any other severe allergic disease (excluding RA itself) that, in the investigator's judgment, may compromise subject safety;
Presence of inflammatory diseases other than RA, including but not limited to psoriatic arthritis, ankylosing spondylitis, or systemic lupus erythematosus;
Severe, progressive, or uncontrolled diseases of the kidneys, liver, blood, gastrointestinal tract, endocrine system, lungs, heart, nervous system, psychiatric conditions, or brain; history of venous thromboembolism, diverticulitis, significantly abnormal or poorly controlled blood lipids;
History of lymphoproliferative disorders, or current or past malignancy;