Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement
Condition: Axial Psoratic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Secukinumab; Secukinumab and Placebo
Intervention description: Anti IL-17a monoclonal antibody; Placebo matching AIN457
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 498 patients were randomized in this Phase 3b trial. 5 (of 503) were mis-randomized, i.e. received randomization number but never received study medication.
This was a 52-week, randomized, double-blind, double-dummy, placebo-controlled, multicenter study to assess the efficacy of secukinumab 150 mg or 300 mg in patients with AxPsA who had an inadequate response to NSAIDs. The study had 2 treatment periods; a placebo-controlled period from Baseline to Week 12 followed by an active treatment period from Week 12 to Week 52.
At Week 12, patients randomized to placebo at Baseline were re-randomized (1:1) to active treatment with secukinumab 150 mg or secukinumab 300 mg.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 503.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Assessment of spondyloarthritis international society; ASAS; axial; Psoriatic Arthritis; PsA; Magnetic resonance imaging; MRI

Summary:

      The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or
      300 mg in the management of axial manifestations in PsA patients who have failed to respond
      to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according
      to assessment of spondyloarthritis international society (ASAS) recommendations for the
      treatment of axial spondyloarthritis (AxSpA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment is performed

          -  Diagnosis of psoriatic arthritis classified by Classification criteria for psoriatic
             arthritis (CASPAR) criteria

          -  Active spinal disease defined by Bath ankylosing spondylitis disease activity index
             (BASDAI) score ≥ 4

          -  Spinal Pain visual analog scale (VAS) ≥ 40 (on a VAS 100 scale)

          -  Inadequate Response to at least 2 non-steroidal anti-inflammatory drugs over a 4 weeks
             period

        Exclusion Criteria:

          -  History of exposure to other IL-17 or IL-23 inhibitor biologic drug

          -  History of exposure to previous biologic disease modifying anti-rheumatic drugs
             (DMARDs) (Tumor necrosis factor (TNF) blockers or Ustekinumab)

          -  Current treatment with disease modifying anti-rheumatic drugs (DMARDs) other than
             Methotrexate

          -  Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone,
             morphine)

          -  Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing
             infectious or malignant process, obtained within 3 months prior to screening and
             evaluated by a qualified physician

        Other protocol-defined inclusion and exclusion criteria may have applied.