At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 503 enrolled
Drug / intervention
Secukinumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Participants With Active Psoriatic Arthritis and Axial Skeleton Involvement Who Have Inadequate Response to Non-steroidal Anti-inflammatory Drugs (NSAIDs)
In Brief
A Phase 3 clinical trial evaluating Secukinumab and Secukinumab and Placebo for Axial Psoratic Arthritis. Completed, enrolled 503 participants across 94 sites in 18 countries.
Detailed Summary
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in PsA patients who have failed to respond to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according to assessment of spondyloarthritis international society (ASAS) recommendations for the treatment of axial spondyloarthritis (AxSpA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAxial Psoratic Arthritis
CountriesBelgium, Bulgaria, Czechia, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Poland, Romania, Russia, Spain, Switzerland, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartOct 2016
Primary CompletionJun 2019
TodayJul 2026
First PostedMar 29, 2016
Enrollment StartOct 3, 2016
Primary CompletionJun 26, 2019
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.3 years ago
Interventions
Secukinumabbiological
Anti IL-17a monoclonal antibody
Secukinumab and Placebodrug
Placebo matching AIN457