A study of axSpA and AS receiving Secukinumab in a treat-to-target strategy.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
88
For intervention description: see arm/group description
Reumatologisk Afdeling, Aarhus Universitetshospital
Aarhus, Denmark
NOT_YET_RECRUITINGVidencenter for Reumatologi og Rygsygdomme, Rigshospitalet - Frederiksberg
Frederiksberg, Denmark
RECRUITINGProportion of patients with a positive change in MRI-inflammation
Assessed with the sum of SPARCC MRI SIJ and spine inflammation indices
Time frame: Comparison of week 16 and 24
Proportion of patients in remission vs patients not in ASDAS (Ankylosing Spondylitis Disease Activity Score) remission.
as measured by remission (\<1.3) / not in ASDAS remission (\>1.3)
Time frame: Comparison of week 16 and 24
Changes in ASDAS score (i.e. Ankylosing Spondylitis Disease Activity Score (ASDAS 0.6-7.0))
as measured by changes in ASDAS.
Time frame: Evaluated from week 0 to 16 and from week 16 to 24
Changes in MRI inflammation scores from week 0 to 16 and week 16 to 24, respectively.
as measured by the SPARCC MRI SIJ and Spine Inflammation indices and the Canada-Denmark MRI system for a positive change in MRI inflammation in the spine as assessed with the Canada-Denmark MRI system for assessment of inflammation.
Time frame: Week 0 to 16 and week 16 to 24
Changes in scores/anatomical location of MRI lesions in the spine
as measured by the Canada-Denmark MRI system for assessment of inflammation, fat metaplasia, erosion, and new bone formation.
Time frame: week 16
Changes in scores/anatomical location of MRI lesions in the SIJs
as measured by the SPARCC MRI SIJ Inflammation Index and SPARCC SIJ Structural Score (SSS)
Time frame: week 16
MRI inflammation
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Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet Glostrup
Glostrup Municipality, Denmark
RECRUITINGKong Christian X´s Gigthospital
Gråsten, Denmark
NOT_YET_RECRUITINGVidencenter for Reumatologi og Rygsygdomme, Rigshospitalet - Gentofte
Hellerup, Denmark
RECRUITINGVidencenter for Reumatologi og Rygsygdomme, Rigshospitalet - Nordsjællands Hospital Hillerød
Hillerød, Denmark
NOT_YET_RECRUITINGReumatologisk Afdeling, Regionshospitalet Nordjylland, Hjørring
Hjørring, Denmark
NOT_YET_RECRUITINGReumatologisk afdeling, Sjællands Universitetshospital, Køge
Køge, Denmark
NOT_YET_RECRUITINGReumatologisk Afdeling, Odense Universitetshospital
Odense, Denmark
NOT_YET_RECRUITINGReumatologisk Afdeling, Regionshospitalet Silkeborg
Silkeborg, Denmark
NOT_YET_RECRUITINGas measured by the SPARCC (Spondyloarthritis Research Consortium of Canada) MRI sacroiliac joint and Spine Inflammation indices and the Canada-Denmark MRI system for assessment of inflammation assessed on cMRI (conventional MRI) i.e. on STIR (short tau inversion recovery) sequences on conventional and novel scan planes and on DWI (Diffusion-weighted imaging) sequences evaluated visually and based on regions of interest (ROIs).
Time frame: week 16