NCT06301373

Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis

Recruiting now NA Last updated 9 September 2025

What this trial tests

NA trial testing Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis in 130 participants. Currently enrolling.

Timeline

1 September 2024

Primary endpoint
1 April 2030

1 April 2030

Quick facts

Lead sponsor	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	130
Start date	1 September 2024
Primary completion	1 April 2030
Estimated completion	1 April 2030
Sites	1 location across China

Drugs / interventions tested

• Methotrexate Combined With Tofacitinib — full drug profile →
• Methotrexate — full drug profile →

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

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

Who can join

Adults 18 to 65, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.