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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

Study acronym: BIO3
StatusRecruiting
PhasePhase 4
Started2016-03-30
View on ClinicalTrials.gov ↗

Amendment history

2025-03-10
Study Status, IPDSharing v3
Primary completion date2025-03→2029-03
Completion date2025-03→2029-03
2022-07-08
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility v2
Primary completion date2022-03→2025-03
Completion date2022-03→2025-03
InterventionsMethotrexate + biologic administration (Drug), methotrexate + salazopyrine + hydroxychloroquine administration (Drug)→Methotrexate + targeted therapy administration (Drug), methotrexate or leflunomide + sulfasalazine + hydroxychloroquine administration…
Eligibility criteria+204 characters
[...] o 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 ass [...] ive method of birth control during the study and continuing 5 months after the enddiscontinuation of the investigational drug or study. The forduration menwill anddepend depending foron the biotherapydrug associated for womenused (referred to the summary product characteristic). Exclusion Criteria: Previous treatment with oneor ofcontraindication theto evaluat [...] [...]
Secondary endpoints12 entries, revised
Blood concentrations of hydroxychloroquine, salazopyrineleflunomide, sulfasalazine and methotrexate in the triple therapy group and methotrexate, leflunomide, biologic / JAK/STAT inhibitor and anti-drug antibody in the other group.
Study title+53 characters
Clinical Trial Evaluating Methotrexate or Leflunomide + BiologicTargeted Therapy Versus Methotrexate, Salazopyrineor andLeflunomide + Sulfasalazine + Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate or Leflunomide
2021-08-05
Not Yet Recruiting→Recruiting Study Identification, Study Status, Conditions, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2020-02→2022-03
Completion date2020-02→2022-03
Start date2016-03→2016-03-30
Study sites0→1
2016-03-15
Original filing
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.
Trial Details
NCT Number NCT02714634
Lead Sponsor University Hospital, Strasbourg, France
Conditions Rheumatoid Arthritis, Insufficient Response to Methotrexate or Leflunomide
Enrollment 286 participants
Start Date 2016-03-30
Primary Completion 2029-03 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2025-03-12