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

NCT07721142 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-07-22

No results posted yet for this study

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)

Interventions

DRUG

Kunxian Capsule

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;

DRUG

Kunxian Capsule Placebo

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;

Sponsors & Collaborators

  • Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2028-03-15
Completion
2028-03-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07721142 on ClinicalTrials.gov