Lead Investigator: Claire Daien, CHU lapeyronie
Title of Proposed Research: The most appropriate conventional DMARD to combine with tofacitinib in Rheumatoid Arthritis post hoc analysis of ORAL sync study
Vivli Data Request: 4039
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by synovial inflammation leading to both cartilage destruction and bone erosions. Targeted therapies have changed management and outcomes of RA patients. JAK inhibitors (tofacitinib) are a new class of targeted synthetic Disease-Modifying-Anti Rheumatic-Drug (tsDMARD) approved as RA treatment, in monotherapy or in combination. Some data indicate that tofacitinib is more efficient in combination with methotrexate (MTX) than in monotherapy. When MTX cannot be used, others conventional synthetic Disease-Modifying-Anti Rheumatic-Drug (called non-MTX csDMARD) such as leflunomide or sulfasalazine can be proposed in combination with tofacitinib but their effectiveness in association is not established. Recent post hoc analysis has been realized for baricitinib in association with csDMARDs but not for tofacitinib.
A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications NCT00856544 article : Kremer J, Li Z-G, Hall S, Fleischmann R, Genovese M, Martin-Mola E, et al. Tofacitinib in combination with nonbiologic disease-modifying antirheumatic drugs in patients with active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2013 Aug 20;159(4):253–61.
Data Contributor: Pfizer Inc.
Study ID: NCT00856544
Update: This data request was withdrawn on 8 June 2021 by the researcher