Clinical Trial Evaluating Methotrexate + Biologic Versus Methotrexate, Salazopyrine and Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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 biologic therapy, such as anti-TNFα, and more recently abatacept or tocilizumab. Triple therapy using 3 conventional disease-modifying drugs (DMARDs), methotrexate+salazopyrine+hydroxychloroquine could be an alternative option to biologics, all the more as they have a more favorable safety profile and a much lower cost. Uncertainty remains regarding the superiority of biologics on triple therapy in methotrexate insufficient responders (IR). Investigators decided to address this issue by performing a randomized controlled pragmatic trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Strasbourg, France
• Treatments: Hydroxychloroquine; Methotrexate; Sulfasalazine

Criteria

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

• 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 5 months after the end of the study for men and depending for the biotherapy associated for women (referred to the summary product characteristic).

Exclusion Criteria:

• Previous treatment with one of the evaluated biologics

• Previous treatment with triple therapy

• Other inflammatory arthritis except RA associated with Sjögren's syndrome

• Contraindication to all biologics or to methotrexate, 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