Integrated Clinical Study of Traditional Chinese and Western Medicine for the Treatment of Refractory Rheumatoid Arthritis Using Renowned Traditional Chinese Medicines
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.
∙ Subjects must meet all of the following criteria to be enrolled in this study:
• 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;
• Patients with RA of the Wind-Damp Bi obstruction pattern according to traditional Chinese medicine (TCM), defined as:
‣ Primary symptoms: joint pain and swelling with a wandering nature; joint pain and swelling with intermittent occurrence.
⁃ Secondary symptoms: aversion to wind, or spontaneous sweating; headache; heaviness of the limbs.
• Tongue and pulse: pale-red tongue with thin white coating, slippery or floating pulse.Diagnosis requires at least 2 primary symptoms, or 1 primary symptom plus 2 secondary symptoms, in combination with tongue and pulse findings.
• Patients with confirmed moderate to severe active RA at screening, defined as ≥6 tender joints (TJC, based on 68-joint count) and ≥6 swollen joints (SJC, based on 66-joint count), with erythrocyte sedimentation rate (ESR) \>28 mm/h or C-reactive protein (CRP) \>10 mg/L, and DAS28-CRP \>3.2;
• Prior inadequate response (DAS28-ESR \>3.2) to at least two disease-modifying antirheumatic drug (DMARD) regimens (excluding methotrexate + JAK inhibitor + Kunxian capsule), each administered for at least 12 weeks.