Study of Efficacy and Safety of Secukinumab in Psoriatic Arthritis and Axial Spondyloarthritis Patients With Active Enthesitis Including One Achilles Tendon Site
Condition: Psoriatic Arthritis; Axial Spondyloarthritis; Enthesitis
MeSH terms: Spondylitis; Arthritis; Arthritis, Psoriatic; Spondylarthritis; Axial Spondyloarthritis; Enthesopathy
Intervention: Secukinumab; Secukinumab Placebo
Intervention description: Induction: Week 0,1,2,3 150 mg or 300 mg Secukinumab s.c. Maintenance: 150 mg or 300 mg Secukinumab s.c. every 4 weeks starting at Week 4; Induction: Week 0,1,2,3 Secukinumab Placebo s.c. Maintenance: Secukinumab Placebo s.c. every 4 weeks starting at Week 4 until Week 24 followed by 150 or 300 mg Secukinumab s.c. every 4 weeks
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Double-blind
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Active psoriatic arthritis; Axial spondyloarthritides; Subcutaneous; Secukinumab in prefilled syringe; Enthesitis; Achilles tendon; AxSpA; PsA

Summary:

      The purpose of this study was to demonstrate efficacy, including effects on inflammation by
      magnetic resonance imaging (MRI) assessments, of secukinumab on Achilles tendon enthesitis
      for up to 1 year with a primary focus at Week 24, in patients with active Psoriatic Arthritis
      and axial Spondyloarthritis despite current or previous non-steroidal anti-inflammatory drugs
      (NSAID) and/or disease modifying anti-rheumatic drug (DMARD) and/or anti-TNFα therapy.
    

Eligibility criteria:

        Key Inclusion Criteria:

        - Patients with Psoriatic arthritis: Diagnosis of Psoriatic arthritis as per the
        Classification criteria for Psoriatic Arthritis (CASPAR criteria) with symptoms for at
        least 6 months and active Psoriatic arthritis as assessed by ≥ 1 tender joints out of 78
        and ≥ 1 swollen joints out of 76 at Baseline (dactylitis of a digit counts as one joint
        each).

        - Patients with Axial Spondyloarthritis: Diagnosis of Axial Spondyloarthritis as per the
        classification of the Assessment of Spondyloarthritis International Society axial
        Spondyloarthritis (ASAS) criteria and objective signs of inflammation at Screening
        (magnetic resonance imaging (MRI) or definite radiographic sacroilitis and/or abnormal
        C-Reactive Protein) and active disease assessed by total Bath ankylosing spondylitis
        disease activity index (BASDAI) ≥ 4 (0-10) at Baseline.

          -  Diagnosis of Achilles tendon enthesitis according to swelling and tenderness at the
             insertional site of the Achilles tendon into the calcaneus.

          -  Onset of heel pain ≥ 1 month at Baseline.

          -  Heel enthesitis that is magnetic resonance imaging (MRI)-positive according to the
             investigator's judgement.

          -  Patients who have been exposed to up to two TNFα inhibitors.

        Key Exclusion Criteria:

          -  Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing
             infectious or malignant process.

          -  Previous exposure to secukinumab or other biologic drug directly targeting Interleukin
             (IL)-17 or Interleukin (IL)-17 receptor.

          -  Ongoing use of psoriasis treatments / medications (e.g. topical corticosteroids,
             ultraviolet (UV) therapy) at randomization.

          -  Patients who have previously been exposed to more than two Tumor necrosis factor (TNF)
             inhibitors (investigational or approved).

          -  Patients who have ever received biologic immunomodulating agents (investigational or
             approved), except those targeting Tumor necrosis factor (TNF) inhibitors.

          -  Pregnant or nursing (lactating) women.

          -  History of ongoing, chronic or recurrent infectious disease or evidence of
             tuberculosis infection.