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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

NCT02714634 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2025-03-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Methotrexate + 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

DRUG

methotrexate or leflunomide + sulfasalazine + hydroxychloroquine administration

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-30
Primary Completion
2029-03-31
Completion
2029-03-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02714634 on ClinicalTrials.gov