Integrated Clinical Study of Traditional Chinese and Western Medicine for Refractory Rheumatoid Arthritis

NCT07721142 | Recruiting Phase 4

• 1 other identifier: 2025-K-74
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (1)

• the ACR20 response rate at week 12

  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.

Study Arms (2)

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

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

Drug: Kunxian Capsule Placebo

Interventions

Kunxian Capsule DRUG

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 group

Kunxian Capsule Placebo DRUG

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;

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine: lead

Study Sites (1)

Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

kunxian

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Dongyi He

CONTACT

15800300800; dongyihe@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: July 22, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): March 15, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-03

Locations

CN (1)