Project

Maximise

Completed · 2016 until 2019

Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Completed
Start Date
2016
End Date
2019
Financing
Industry
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
Keywords
Psoriasis Arthritis mit axialer Beteiligung, secukinumab
Homepage
Brief description/objective

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)