Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis - Trial NCT06301373

Timeline & Enrollment

Primary Outcome

The proportion of subjects who achieved ACR20

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.

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