BridgeMD
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
EU CTIS ID: 2024-516704-41-00
What this study is testing
To demonstrate whether or not targeted therapies are more effective than triple therapies in methotrexate or leflunomide-IR patients with RA.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 and/or 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
You likely can't join if
- Previous treatment with or contraindication to targeted therapies (biologic or JAK/STAT inhibitor)*
- 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
- Previous treatment with or contraindication to triple therapy*
See the full eligibility 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 and/or 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 (blood test)
- 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).
- Previous treatment with or contraindication to targeted therapies (biologic or JAK/STAT inhibitor)*
- 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
- Previous treatment with or contraindication to triple therapy*
- Other inflammatory arthritis except those associated to 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 for patients in the biologic arm
- Patient who cannot be followed during 12 months
- Pregnancy, breastfeeding, desire of pregnancy in the 12 months
- Drug addiction, addiction to alcohol
The study team makes the final eligibility decision.
Where it's taking place
- Monaco
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Monaco. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.