RecruitingNot ApplicableNCT06301373

Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis

Methotrexate Combined With Tofacitinib in the Treatment of Active Rheumatoid Arthritis With a Myeloid-stromal Pathotype: a Randomized, Controlled, Open Label, Multicenter Clinical Study

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

130 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis

Summary

Rheumatoid arthritis (RA) is the leading cause of disability in Chinese women. We established a synovial pathology queue in the early stage and proposed a new synovial immunopathology classification. We found that baseline myeloid stromal RA patients had severe conditions and poor outcome. Early identification of synovial myeloid stromal RA patients and intensified treatment are key to improving RA efficacy. This project aims to conduct a randomized, controlled, open label, multicenter clinical study on early intensified treatment of RA based on synovial pathology classification. 130 adult patients with synovial myeloid stromal type of primary treatment moderate to severe active RA were planned to be enrolled in three centers: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; Shenshan Medical Center, Memorial Hospital of Sun Yat-Sen University, and Guangzhou Panyu Central Hospital. They were randomly divided into an intensive treatment group and a conventional treatment group in a 1:1 ratio. The intensive treatment group was treated with methotrexate combined with tofacitinib, while the conventional treatment group was treated with methotrexate monotherapy. The expected intervention period is 12 weeks, with a follow-up period of 48 weeks. The primary endpoint is the proportion of subjects who achieved ACR20 at week 12. Secondary endpoint indicators include improvement in disease activity and joint function among subjects at different follow-up points, safety, and the proportion of subjects who experienced joint destruction progression at week 48. This project proposes the concept of achieving precise diagnosis of RA based on synovial pathology classification, and explores the efficacy of early methotrexate combined with tofacitinib intensified treatment for patients with synovial medullary stromal RA who have poor conventional treatment efficacy, providing high-level clinical evidence for achieving precise initial treatment of RA treatment guidelines.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether combining two medications — methotrexate and tofacitinib — works better than standard therapy alone in people with rheumatoid arthritis (RA) who have moderate or high disease activity and a specific type of joint inflammation pattern on biopsy called myeloid-stromal pathotype. **You may be eligible if...** - You have been diagnosed with rheumatoid arthritis - Your RA is moderately or highly active - You have had a joint biopsy confirming the myeloid-stromal inflammation pattern - You are willing to follow the study protocol and sign informed consent **You may NOT be eligible if...** - You received conventional RA disease-modifying drugs in the 12 weeks before the study - You received biologic agents (e.g., adalimumab, etanercept) in the 6 months before the study - You received a JAK inhibitor (such as tofacitinib) before the study - You have serious uncontrolled health conditions (e.g., severe diabetes, respiratory or liver disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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