Integrated Clinical Study of Traditional Chinese and Western Medicine for Refractory Rheumatoid A… (NCT07721142) | Clinical Trial Compass
RecruitingPhase 4
Integrated Clinical Study of Traditional Chinese and Western Medicine for Refractory Rheumatoid Arthritis
China300 participantsStarted 2025-10-15
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the ACR20 response rate at week 12
Timeframe: To compare the ACR20 response rate at week 12 between the Kunxian Capsule combined with methotrexate (MTX) and JAK inhibitor (JAKi) group and the methotrexate (MTX) plus JAK inhibitor (JAKi) group.
Trial details
NCT IDNCT07721142
SponsorShanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
. 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.
Exclusion criteria
. 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;
. Meeting any of the following criteria for tuberculosis screening, which require exclusion:
. Presence or history of active infections, including:
. History of recurrent herpes zoster, disseminated herpes zoster, or disseminated herpes simplex, or history of herpes zoster or herpes simplex within 2 months prior to randomization;
. Positive hepatitis B surface antigen (HBsAg) and/or HBV DNA \>50 IU/mL (or \>500 copies/mL) at screening; positive hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody;