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

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) is a Phase 4 interventional studying Rheumatoid Arthritis and Insufficient Response to Methotrexate or Leflunomide, sponsored by University Hospital, Strasbourg, France. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 286 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Rheumatoid Arthritis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Patient with rheumatoid arthritis according to EULAR/ACR 2010 criteria - DAS28-CRP\>3.2 - Insufficient response to methotrexate at a weekly dose≥15mg after at least 3 months or to leflunomide at a dose of 10 (in case 20 mg are not well tolerated) to 20 mg per day after 3 months of treatment - RA radiographic erosions and/or serum rheumatoid factor associated to anti-Cyclic Citrullinated Peptide (Anti-CCP) - Age greater or equal to 18 years - Written willing to sign a consent form, dated and signed before initiating any trial-related procedure - Affiliation to a social insurance system - Women of child bearing potential, negative β-HCG assay (Human chorionic gonadotropin) - Effective method of birth control during the study and continuing after the discontinuation of the investigational drug or study. The duration will depend on the drug used (referred to the summary product characteristic). Who Should NOT Join This Trial: - Previous treatment with or contraindication to targeted therapies (biologic or JAK/STAT inhibitor) - Previous treatment with triple therapy - Other inflammatory arthritis except RA associated with Sjögren's syndrome - Contraindication to all biologics/ JAK/STAT inhibitors or to methotrexate, leflunomide, sulfasalazine and hydroxychloroquine - Corticosteroids at a dose \>15 mg/d of equivalent prednisone for at least 4 weeks before the inclusion - Absence of tuberculosis screening - Patient who cannot be followed during 12 months - Pregnancy, breastfeeding, desire of pregnancy in the 12 months - Drug addiction, addiction to alcohol - Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment - Women of child bearing potential, unless they are using an effective method of birth control - Patient under law protection - Prisoners Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Patient with rheumatoid arthritis according to EULAR/ACR 2010 criteria * DAS28-CRP\>3.2 * Insufficient response to methotrexate at a weekly dose≥15mg after at least 3 months or to leflunomide at a dose of 10 (in case 20 mg are not well tolerated) to 20 mg per day after 3 months of treatment * RA radiographic erosions and/or serum rheumatoid factor associated to anti-Cyclic Citrullinated Peptide (Anti-CCP) * Age greater or equal to 18 years * Written informed consent, dated and signed before initiating any trial-related procedure * Affiliation to a social insurance system * Women of child bearing potential, negative β-HCG assay (Human chorionic gonadotropin) * Effective method of birth control during the study and continuing after the discontinuation of the investigational drug or study. The duration will depend on the drug used (referred to the summary product characteristic). Exclusion Criteria: * Previous treatment with or contraindication to targeted therapies (biologic or JAK/STAT inhibitor) * Previous treatment with triple therapy * Other inflammatory arthritis except RA associated with Sjögren's syndrome * Contraindication to all biologics/ JAK/STAT inhibitors or to methotrexate, leflunomide, sulfasalazine and hydroxychloroquine * Corticosteroids at a dose \>15 mg/d of equivalent prednisone for at least 4 weeks before the inclusion * Absence of tuberculosis screening * Patient who cannot be followed during 12 months * Pregnancy, breastfeeding, desire of pregnancy in the 12 months * Drug addiction, addiction to alcohol * Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment * Women of child bearing potential, unless they are using an effective method of birth control * Patient under law protection * Prisoners

Treatments Being Tested

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT02714634), the sponsor (University Hospital, Strasbourg, France), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT02714634 clinical trial studying?

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), metho… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT02714634?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT02714634?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT02714634. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT02714634. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.