Rheumatoid Arthritis (RA)Phase 4NCT07721142
Integrated Clinical Study of Traditional Chinese and Western Medicine for Refractory Rheumatoid Arthritis
A Phase 4 study testing Kunxian Capsule in people with Rheumatoid Arthritis (RA), run by Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Kunxian Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2025to 15 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Subjects meeting any of the following conditions will not be eligible for enrollment:
- 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:
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- History of active tuberculosis;
- Recent close contact with patients with active tuberculosis;
- Signs or symptoms of active tuberculosis based on medical history and physical examination;
- Chest CT scan within 3 months prior to enrollment showing evidence of active pulmonary tuberculosis;
- Positive interferon-gamma release assay (IGRA) within 6 weeks prior to enrollment;
- Presence or history of active infections, including:
- Receipt of systemic anti-infective therapy within 4 weeks prior to randomization;
- Pharyngalgia, nasal congestion, acute upper respiratory tract infection, or systemic acute infection within 2 weeks prior to randomization;
- Recurrent, chronic, or other active infections at screening that, in the investigator's judgment, may increase subject risk;
- 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;
- Receipt of, or planned receipt of, live or attenuated vaccines within 3 months prior to the first dose of study medication, during the study, or within 6 months after the last study dose;
- Pregnant, breastfeeding, planning pregnancy, or planning fatherhood during the study or within 6 months after the last dose; females or males with fertility requirements;
- Clinically significant abnormalities on 12-lead ECG at screening that may increase subject risk, in the investigator's judgment;
- Any other disease at screening that may interfere with study assessments;
- Laboratory abnormalities at screening, defined as:
- Hemoglobin <100.0 g/L in males, or <90.0 g/L in females;
- White blood cell (WBC) count <4.0 × 10⁹/L;
- Neutrophil count <1.5 × 10⁹/L;
- Platelet (PLT) count <100 × 10⁹/L;
- Lymphocyte count <0.5 × 10⁹/L;
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TBIL), or serum creatinine (Scr) above the upper limit of normal;
- Hematology, liver function, or renal function abnormalities that, in combination with medical history and/or additional examinations, are deemed clinically significant by the investigator;
- Prior use of any of the following drugs or treatments:
- Strong opioids within 1 week prior to randomization;
- Any JAK inhibitor within 2 weeks prior to randomization;
- Nonsteroidal anti-inflammatory drugs (NSAIDs) at the time of randomization with dosage adjustments within 2 weeks prior;
- Prednisone or equivalent corticosteroid >10 mg/day at randomization; or ≤10 mg/day with dosage adjustment within 4 weeks prior to randomization;
- Intra-articular, intramuscular, intravenous, trigger-point, bursal, or tendon-sheath corticosteroid injections within 4 weeks prior to randomization or during the study;
- Concurrent participation in another drug clinical trial;
- Any clinically significant abnormalities in clinical or laboratory examinations, or any other reason deemed inappropriate for study participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai
Dongyi He, 15800300800, dongyihe@medmail.com.cn
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Kunxian Capsule, Kunxian Capsule Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kunxian CapsuleDrug
Experimental Group (Kunxian Capsule Group + MTX + JAKi):
- Kunxian Capsule Placebo: 3 times daily, 0.3-0.6g each time, taken orally after meals; treatment duration: 12 weeks;
- Methotrexate: Once weekly, 10-15mg each time, taken orally after meals; treatment duration: 12 weeks;
- Tofacitinib: 2 times daily, 1 tablet each time, taken orally; treatment duration: 12 weeks;
Kunxian Capsule PlaceboDrug
Placebo Comparator Group (Kunxian Capsule Placebo Group + MTX + JAKi):
- Kunxian Capsule Placebo: 3 times daily, 0.3-0.6g each time, taken orally after meals; treatment duration: 12 weeks;
- Methotrexate: Once weekly, 10-15mg each time, taken orally after meals; treatment duration: 12 weeks;
- Tofacitinib: 2 times daily, 1 tablet each time, taken orally; treatment duration: 12 weeks;
| Study group | Role | What they receive |
|---|---|---|
| Kunxian Capsule group | Experimental | Kunxian Capsule (0.3 g per capsule, orally, 3 capsules each time, three times daily) combined with Methotrexate (10-15mg/week) and Tofacitinib (5 mg twice daily) for 12 weeks, followed by 12 weeks of maintenance treatment with the same regimen Receives: Drug: Kunxian Capsule |
| Placebo group | Placebo comparator | Kunxian Capsule placebo (identical in appearance and odor, orally, 3 capsules each time, three times daily) combined with Methotrexate (10-15mg/week) and Tofacitinib (5 mg twice daily) for 12 weeks; all participants then switch to Kunxian Capsule plus Methotrexate and Tofacitinib for the following 12 weeks Receives: Drug: Kunxian Capsule Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the ACR20 response rate at week 12
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start15 Oct 2025
- Primary completion15 Mar 2028 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongyi He, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721142
- Sponsor's protocol ID
- 2025-K-74
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Clinical Study of Traditional Chinese and Western Medicine for the Treatment of Refractory Rheumatoid Arthritis Using Renowned Traditional Chinese Medicines
- ClinicalTrials.gov ID
- NCT07721142
- Acronym / sponsor ID
- 2025-K-74
- Conditions
- Rheumatoid Arthritis (RA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western MedicineUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kunxian Capsule group | Experimental | Drug: Kunxian CapsuleKunxian Capsule (0.3 g per capsule, orally, 3 capsules each time, three times daily) combined with Methotrexate (10-15mg/week) and Tofacitinib (5 mg twice daily) for 12 weeks, followed by 12 weeks of maintenance treatment with the same regimen |
| Placebo group | Placebo comparator | Drug: Kunxian Capsule PlaceboKunxian Capsule placebo (identical in appearance and odor, orally, 3 capsules each time, three times daily) combined with Methotrexate (10-15mg/week) and Tofacitinib (5 mg twice daily) for 12 weeks; all participants then switch to Kunxian Capsule plus Methotrexate and Tofacitinib for the following 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (37 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kunxian CapsuleExperimental Group (Kunxian Capsule Group + MTX + JAKi): * Kunxian Capsule Placebo: 3 times daily, 0.3-0.6g each time, taken orally after meals; treatment duration: 12 weeks; * Methotrexate: Once weekly, 10-15mg each time, taken orally after meals; treatment duration: 12 weeks; * Tofacitinib: 2 times daily, 1 tablet each time, taken orally; treatment duration: 12 weeks; | Drug | Kunxian Capsule group |
| Kunxian Capsule PlaceboPlacebo Comparator Group (Kunxian Capsule Placebo Group + MTX + JAKi): * Kunxian Capsule Placebo: 3 times daily, 0.3-0.6g each time, taken orally after meals; treatment duration: 12 weeks; * Methotrexate: Once weekly, 10-15mg each time, taken orally after meals; treatment duration: 12 weeks; * Tofacitinib: 2 times daily, 1 tablet each time, taken orally; treatment duration: 12 weeks; | Drug | Placebo group |
Primary outcome
the ACR20 response rate at week 12
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kunxian Capsule in people with Rheumatoid Arthritis (RA), run by Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongyi He (15800300800, dongyihe@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the ACR20 response rate at week 12 (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.