A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive 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: Participants will receive Placebo subcutaneous (SC) injection at Weeks 0, 4, and 16 in Group 1 and at Week 24 in Group 2 and Group 3.; Participants will receive 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 100 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 100 in Group 2.; Participants will receive Ustekinumab 90 mg SC injection at Weeks 24 and 28 followed by q12w dosing, with the last administration of study agent at Week 100 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 100 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 Groups 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: 347.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Axial Spondyloarthritis; Ustekinumab; Golimumab; Stelara

Summary:

      The purpose of this study is to assess the efficacy of ustekinumab, in adult participants
      with active radiographic axial spondyloarthritis (AxSpA), who are naive to anti-TNF alpha
      agents, 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 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

          -  If using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics for AS,
             must be on a stable dose for at least 2 weeks prior to the first administration of
             study agent. If currently not using NSAIDs or other analgesics for AS, must not have
             received NSAIDs or other analgesics for AS for at least 2 weeks prior to the first
             administration of the study agent

          -  A woman of childbearing potential must have a negative serum (beta-human chorionic
             gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test at Week 0
             before randomization

        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 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 prior biologic therapy, including but not limited
             to anti-TNF alpha agents, tocilizumab, alefacept, efalizumab, natalizumab, abatacept,
             anakinra, ustekinumab, tidrakizumab or other anti-interleukin (IL) 23 biologics,
             brodalumab, secukinumab, ixekizumab, and B-cell depleting therapies

          -  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 chloroquine,
             azathioprine, cyclosporine, mycophenolate mofetil, gold, and penicillamine

          -  Participant who have received leflunomide within 3 months prior to the first
             administration of study agent (irrespective of undergoing a drug elimination
             procedure), or have received leflunomide within 12 months prior to the first
             administration of study agent and have not undergone a drug elimination procedure