NCT03639740

Treat-to-target With Secukinumab in Axial Spondyloarthritis

TReat-to-tArget (T2T) With seCukinumab in Axial Spondyloarthritis. IdEntification of MRI and Biochemical Biomarkers for Disease Activity, Treatment Response and Structural Damage Progression (the TRACE Study)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Professor Mikkel Østergaard · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A study of axSpA and AS receiving Secukinumab in a treat-to-target strategy.

Detailed description

Comparison of reductions in MRI inflammation in the sacroiliac joints and spine from week 16 to 24 in patients who at week 16 are in ASDAS remission (i.e. continue sc. secukinumab 150 mg monthly) vs. not in ASDAS remission (i.e. increase sc. secukinumab 300 mg monthly). ASDAS remission is defined as ASDAS inactive disease i.e. ASDAS\<1.3.

Conditions

• Axial Spondyloarthritis
• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Secukinumab 150 milligram [Cosentyx]	For intervention description: see arm/group description

Timeline

• Start date: 2019-01-15
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2018-08-21
• Last updated: 2019-01-03

Locations

10 sites across 1 country: Denmark