A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Intervention: Placebo; Ustekinumab 45 mg; Ustekinumab 90 mg; Golimumab 50 mg
Intervention description: Placebo subcutaneous (SC) injection at Weeks 0, 4, and 16 in Group 1.; Ustekinumab 45 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52 in Group 1. Participants will start with ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52 in Group 2.; Ustekinumab 90 mg SC injection at Weeks 24 and 28 followed by q12w dosing, with the last administration of study agent at Week 52 in Group 1. Participants will start with ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52 in Group 3.; Participants who meet EE criteria (less than [<] 10 percent [%] improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52 in Group 1, 2 and 3.
Intervention MeSH terms: Golimumab; Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 315.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing Spondylitis; Ustekinumab; Golimumab; STELARA

Summary:

      The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha)
      refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured
      by the reduction in signs and symptoms of radiographic AxSpA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have a diagnosis of definite ankylosing spondylitis (AS), as defined
             by the modified 1984 New York criteria. The radiographic criterion must be confirmed
             by a central xray reader and at least 1 clinical criterion must be met

          -  Participants must have symptoms of active disease at screening and at baseline, as
             evidenced by both a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score
             of greater than or equal to (>=4) and a visual analog scale (VAS) score for total back
             pain of >=4, each on a scale of 0 to 10

          -  Participants with elevated high sensitivity C-reactive protein (hsCRP) level of
             >=0.300 milligram per deciliter (mg/dL) at screening

          -  Refractory by either lack of benefit or documented intolerance to 1 and no more than 1
             anti-TNF(alpha) agent

          -  Inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over a
             4-week period in total with maximal doses of NSAID(s), or is unable to receive a full
             4 weeks of maximal NSAID therapy because of intolerance, toxicity, or
             contraindications to NSAIDs.

          -  Participants with complete ankylosis of the spine are permitted to be included in the
             study, but will be limited to approximately 10 percent (%) of the study population

        Exclusion Criteria:

          -  Participants who have other inflammatory diseases that might confound the evaluations
             of benefit from the ustekinumab therapy, including but not limited to, rheumatoid
             arthritis, systemic lupus erythematosus, or Lyme disease

          -  Participants who have received infliximab or infliximab biosimilar, within 12 weeks of
             the first study agent administration; have received adalimumab, adalimumab biosimilar,
             or certolizumab pegol within 6 weeks of the first study agent administration; have
             received etanercept or etanercept biosimilar within 6 weeks of the first study agent
             administration

          -  Participants who have ever received golimumab

          -  Participants who are pregnant, nursing, or planning a pregnancy or fathering a child
             while enrolled in the study or within 5 months after receiving the last administration
             of study agent

          -  Participants who have received any systemic immunosuppressives or disease-modifying
             antirheumatic drugs (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or
             hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent.
             Medications in these categories include, but are not limited to leflunomide,
             chloroquine, azathioprine, cyclosporine, mycophenolate mofetil, gold, and
             penicillamine