An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis
Condition: Nonradiographic Axial Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Spondylitis, Ankylosing; Non-Radiographic Axial Spondyloarthritis
Intervention: Group 1: Placebo; Group 2: Ustekinumab 45 mg; Group 3: Ustekinumab 90 mg
Intervention description: Participants will receive placebo SC at Weeks 0, 4, 16, and 20. At Week 24, all participants (except those who early escaped) will crossover to receive ustekinumab 45 or 90 mg SC at Weeks 24 and 28 followed by every 12 weeks up to Week 52. At Week 16, participants in placebo group with < 10% improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16 will enter early escape to receive ustekinumab 45 mg or 90 mg at Weeks 16, 20, and 28 followed by every 12 weeks up to Week 52. At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and 52 will be re-randomized to receive placebo or ustekinumab every 12 weeks up to Week 88. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or 52 will continue with ustekinumab every 12 weeks up to Week 88.; Participants will receive ustekinumab 45 mg subcutaneously at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants will receive placebo subcutaneously to maintain the blind. At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and Week 52 will be re-randomized to receive either placebo or ustekinumab 45 mg every 12 weeks in a blinded fashion. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or Week 52 will continue receiving ustekinumab 45 mg every 12 weeks through Week 88.; Participants will receive ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants will receive placebo subcutaneously to maintain the blind. At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and Week 52 will receive either placebo or ustekinumab 90 mg every 12 weeks in a blinded fashion. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or Week 52 will continue receiving ustekinumab 90 mg every 12 weeks through Week 88.
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 356.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Nonradiographic Axial Spondylitis, Ankylosing; Ustekinumab

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).
    

Eligibility 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