Comparing targeted therapy with triple therapy for rheumatoid arthritis patients not responding to standard treatments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of adding targeted therapy to methotrexate or leflunomide versus using a combination of conventional disease-modifying drugs (DMARDs) in patients with rheumatoid arthritis who have not responded adequately to these first-line treatments. The study aims to determine which approach provides better outcomes for patients who have insufficient responses to methotrexate or leflunomide. Participants will receive either the targeted therapy or a triple therapy regimen, and their responses will be monitored over time to assess improvements in their condition.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpitaux Universitaires de Strasbourg
  Strasbourg, France Recruiting

Study contacts

• Study coordinator: Jacques-Eric GOTTENBERG, Professor
• Email: jacques-eric.gottenberg@chru-strasbourg.fr
• Phone: 3 88 12 79 53

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• GenAI-assisted RA bone erosion risk and DMARD choice

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• Pain patterns in rheumatic diseases: see if pain works differently in patients and healthy people

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• Telitacicept for difficult-to-treat rheumatoid arthritis

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• PTC844 in people with active rheumatoid arthritis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.