AScalate: Treat-to-target in Axial Spondyloarthritis

  • STATUS
    Recruiting
  • End date
    Jun 23, 2022
  • participants needed
    300
  • sponsor
    Novartis Pharmaceuticals
Updated on 8 December 2021
adalimumab
secukinumab
steroidal anti-inflammatory drugs
MRI
NSAID
biological therapy
spondylitis

Summary

This is a randomized, parallel-group, open-label, multicenter study of patients with active axSpA. The aim is to demonstrate that the efficacy of a Treat-to-Target (T2T) approach (with secukinumab as first-line biologic) is superior to a Standard-Of-Care (SOC) approach in terms of achieving strong clinical efficacy in patients with active axial Spondyloarthritis (axSpA) who are nave to biological therapy and who have had an inadequate response to non-steroidal anti-inflammatory drugs. The study will include an 8-week Screening period, a 36-week treatment period according to previous randomization, and a safety follow-up period of 20 weeks. The primary endpoint is the percentage of patients achieving an Assessment in SpondyloArthritis international Society response 40 (ASAS40) at Week 24.

Details
Condition Axial Spondyloarthritis
Treatment Standard-of-Care, Secukinumab/Adalimumab-Biosimilar
Clinical Study IdentifierNCT03906136
SponsorNovartis Pharmaceuticals
Last Modified on8 December 2021

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