An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spo… (NCT02407223) | Clinical Trial Compass
TerminatedPhase 3
An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis
Stopped: This study was stopped because ustekinumab did not achieve key endpoints in a related study. The safety profile was consistent with past ustekinumab studies.
Argentina356 participantsStarted 2015-07-13
Plain-language summary
The purpose of this study is to assess the efficacy and safety of ustekinumab in adult participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA).
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Participants must be classified as having nonradiographic axial spondyloarthritis (nr-AxSpA) based on 2009 Assessment of SpondyloArthritis International Society (ASAS) criteria
* Must have an age at nr-AxSpA onset of \<= 45 years
* Must have at screening or active inflammation on magnetic resonance imaging (MRI) as evidenced by the central readers and no radiographic sacroiliitis that fulfills the 1984 modified New York Criteria
* Must have symptoms of active disease at screening and at baseline, as evidenced by both a BASDAI score of \>= 4 and a visual analogue scale (VAS) score for total back pain of more than or equal to (\>=) 4, each on a scale of 0 to 10
Exclusion Criteria:
* Have radiographic sacroiliitis fulfilling the 1984 modified New York Criteria
* Have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy
* Have received any systemic immunosuppressives or disease-modifying anti-rheumatic drug (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent
* Have received epidural, intra-articular, intramuscular (IM), or intravenous (IV) corticosteroids, including adrenocorticotropic hormone during the 4 weeks prior to first administration of study agent
* Have received prior biologic therapy other than anti-TNFα
* Have received more than 1 prior anti-TNFα agent
What they're measuring
1
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24