RecruitingPhase 4NCT02714634

Clinical Trial Evaluating Methotrexate or Leflunomide + Targeted Therapy Versus Methotrexate or Leflunomide + Sulfasalazine + Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate or Leflunomide

Randomized Controlled Clinical Trial Evaluating Methotrexate or Leflunomide + Targeted Therapy Versus Methotrexate or Leflunomide + Sulfasalazine + Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate or Leflunomide


Sponsor

University Hospital, Strasbourg, France

Enrollment

286 participants

Start Date

Mar 30, 2016

Study Type

INTERVENTIONAL

Conditions

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 therapy, such as anti-TNFα, and more recently abatacept or tocilizumab. Triple therapy using 3 conventional disease-modifying drugs (DMARDs), methotrexate or leflunomide+salazopyrine+hydroxychloroquine could be an alternative option to targeted therapies, all the more as they have a more favorable safety profile and a much lower cost. Uncertainty remains regarding the superiority of targeted therapies on triple therapy in methotrexate or leflunomide insufficient responders (IR). Investigators decided to address this issue by performing a randomized controlled pragmatic trial.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment approaches for people with rheumatoid arthritis (a condition where the immune system attacks the joints) who have not improved enough on their current medication — one approach adds a targeted biologic drug, while the other combines three existing medications. **You may be eligible if...** - You have been diagnosed with rheumatoid arthritis - Your disease is still moderately to severely active despite treatment - You have been taking methotrexate or leflunomide for at least 3 months at the recommended dose without enough improvement - You have signs of joint damage on X-rays or specific antibodies in your blood (rheumatoid factor or anti-CCP) - You are 18 years or older - Women of childbearing age must have a negative pregnancy test and use effective contraception **You may NOT be eligible if...** - You are pregnant or not using reliable birth control - You have had a serious reaction to the study medications before - You have other significant health conditions that would interfere with the study 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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Interventions

DRUGMethotrexate + targeted therapy administration

* Methotrexate or leflunomide + adalimumab or * Methotrexate or leflunomide + certolizumab or * Methotrexate or leflunomide + etanercept or * Methotrexate or leflunomide + golimumab or * Methotrexate or leflunomide + infliximab or * Methotrexate or leflunomide + abatacept or * Methotrexate or leflunomide + rituximab or * Methotrexate or leflunomide + tocilizumab or * Methotrexate or leflunomide + sarilumab or * Methotrexate or leflunomide + filgotinib or * Methotrexate or leflunomide + upadacitinib or * Methotrexate or leflunomide + Tofacitinib or * Methotrexate or leflunomide + baricitinib

DRUGmethotrexate or leflunomide + sulfasalazine + hydroxychloroquine administration

Locations(1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

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NCT02714634


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