A Pragmatic Randomized Pilot Trial of Interleukin-17 Inhibition Versus Janus Kinase Inhibition After Tumor Necrosis Factor-alpha Inhibitor Failure in Axial Spondyloarthritis
The University of Texas Health Science Center, Houston
Summary
The purpose of this study is to determine the feasibility of conducting a pragmatic trial of IL-17i versus JAKi in adults with axial spondyloarthritis (axSpA) who have failed at least one tumor necrosis factor-alpha inhibitor (TNFi), to estimate the effectiveness of IL-17i versus JAKi at 16 weeks and to determine additional effectiveness measures, safety, and treatment persistence of IL-17i versus JAKi
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * fulfill ASAS classification criteria for axSpA and/or modified New York classification criteria for AS * Active axSpA (ASDAS ≥ 2.1 and/or BASDAI ≥ 4) * Failure of or intolerance to ≥1 TNF * Participants of reproductive potential must agree to use any form of effective contraception during the study period, in accordance with standard clinical practice and FDA labeling for the assigned study medication * Ability to provide informed consent Exclusion Criteria: * Previously received an IL-17i or JAKi * Active infection requiring antimicrobials * Contraindications to eithe…
Interventions
- DrugSecukinumab (IL-17i )
Secukinumab is a fully humananized monoclonal antibody targeting interleukin-17A. Secukinumab will be given as a prefilled syringe or autoinjector for subcutaneous administration. Dosing is 150 mg subcutaneously at weeks 0, 1, 2, 3, and 4 followed by 150mg every 4 weeks thereafter for a total of 16 weeks.
- DrugUpadacitinib (JAKi)
Upadacitinib is an oral selective inhibitor of janus kinase 1 (JAK1). Participants will take upadacitinib 15mg orally once daily for 16 weeks.
Location
- The University of Texas health Science Center at HoustonHouston, Texas