Overview

Clinical Trial Evaluating Methotrexate + Biologic Versus Methotrexate, Salazopyrine and Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate

Status:
Recruiting

Trial end date:
2022-03-01

Target enrollment:

Participant gender:

Summary

Approximately, 40 to 50% of patients with rheumatoid arthritis (RA), the most frequent inflammatory arthritide, are non responders to the consensual 1st line of treatment : methotrexate. In these patients, it is well demonstrated that the addition of other immunomodulatory drug(s) often results in a significant improvement. However, the best option regarding the drug(s) to add remains unclear. Rheumatologists are currently used to adding a targeted biologic therapy, such as anti-TNFα, and more recently abatacept or tocilizumab. Triple therapy using 3 conventional disease-modifying drugs (DMARDs), methotrexate+salazopyrine+hydroxychloroquine could be an alternative option to biologics, all the more as they have a more favorable safety profile and a much lower cost. Uncertainty remains regarding the superiority of biologics on triple therapy in methotrexate insufficient responders (IR). Investigators decided to address this issue by performing a randomized controlled pragmatic trial.

Phase:

Phase 4

Details

Lead Sponsor:

University Hospital, Strasbourg, France

Treatments:

Hydroxychloroquine
Methotrexate
Sulfasalazine