A Pragmatic Trial of Interleukin-17 Inhibition Versus Janus Kinase Inhibition After Tumor Necrosis Factor-alpha Inhibitor Failure in Axial Spondyloarthritis

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Previously received an IL-17i or JAKi

Active infection requiring antimicrobials

Inflammatory bowel disease (IBD)- Crohn's disease or Ulcerative Colitis

Active cancer or cancer remission within the past 3 years (apart from non-melanoma skin cancer (NMSC) and cervical intraepithelial neoplasia (CIN)

Trial design

Treatments tested in this trial

  • Secukinumab (IL-17i )
  • Upadacitinib (JAKi)

Treatment groups

40 Participants
are divided into 2 treatment groups