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Maximise

Mira Bartz Batliner, Carina Hutz, Silvia Forrer & Andrea Rubbert Roth

abstract MAXIMISE (Managing AXIal Manifestations in PsorIatic
Arthritis with SEcukinumab), a randomized, double-blind,
placebo-controlled, multicenter, 52-week study to assess
the efficacy and safety of secukinumab 150 mg or 300 mg
s.c. in patients with active psoriatic arthritis and axial
skeleton involvement who have inadequate response to
non-steroidal anti-inflammatory drugs (NSAIDs)
   
project homepage http://https://clinicaltrials.gov/ct2/show/NCT02721966
type of project clinical studies
status completed
start of project 2016
end of project 2019
study design To evaluate secukinumab 150 mg s.c. versus placebo in achieving an improvement in
ASDAS at Week 12.
 Proportion of patients in each treatment group with improvement in ASDAS at Week 52.
 To evaluate secukinumab 300 mg s.c. versus placebo in achieving an improvement in
modified nail psoriasis severity index (mNAPSI) at Week 12 for those patients with nail
psoriasis at Baseline.
 To evaluate secukinumab 150 mg s.c. versus placebo in achieving an improvement in
mNAPSI at Week 12 for those patients with nail psoriasis at Baseline.
 Proportion of patients in each treatment group with any reduction in mNAPSI score at
Week 52.
 To evaluate secukinumab 300 mg s.c. versus placebo in achieving a reduction of bone
marrow edema measured by MRI, i.e. Berlin MRI score for spine and sacroiliac joint at
Week 12.
 To evaluate secukinumab 150 mg s.c. versus placebo in achieving a reduction of bone
marrow edema measured by MRI, i.e. Berlin MRI score for spine and sacroiliac joint at
Week 12.
 Proportion of patients in each treatment group with any reduction in bone marrow edema
measured by the Berlin MRI score for spine and sacroiliac joint at Week 52
responsible person Prof. Dr. Rubbert-Roth