Overview

An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis

Status:
Terminated
Trial end date:
2017-09-26
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Benzocaine
Ustekinumab
Criteria
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