Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Secukinumab
Intervention description: Anti IL-17a monoclonal antibody
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 997.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis; Arthritis; Psoriatic; Psoriatic Arthropathy; Spondylitis

Summary:

      The purpose of this study was to demonstrate efficacy including effect on inhibition of
      progression of structural damage, safety and tolerability up to 2 years with primary focus at
      Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe
      (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects
      with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or
      previous anti-TNFα therapy. Long term efficacy up to 2 years was based on signs and symptoms
      of joint/bone structure preservation (X-ray) and improvement in physical function measured by
      Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail
      improvement for psoriasis signs.
    

Eligibility criteria:

        Inclusion Criteria:

        Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with
        moderate to severe PsA who must have at BSL ≥3 tender joints out of 78 and ≥3 swollen
        joints out of 76 (dactylitis of a digit counts as one joint each).

          -  Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies
             negative at screening.

          -  Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a
             documented history of plaque psoriasis.

          -  Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization
             with inadequate control of symptoms or at least one dose if stopped due to intolerance
             to NSAIDs.-Subjects who are regularly taking NSAIDs as part of their PsA therapy are
             required to be on a stable dose for at least 2 weeks before study randomization and
             should remain on a stable dose up to Week 24.

          -  Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or
             equivalent for at least 2 weeks before randomization and should remain on a stable
             dose up to Week 24.

          -  Subjects taking MTX (≤ 25 mg/week) are allowed to continue their medication if the
             dose is stable for at least 4 weeks before randomization and should remain on a stable
             dose up to Week 52.

          -  Subjects on MTX must be on folic acid supplementation at randomization.

          -  Subjects who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to
             randomization visit except for leflunomide, which has to be discontinued for 8 weeks
             prior to randomization unless a cholestyramine wash-out has been performed.

          -  Subjects who have been on a TNFα inhibitor must have experienced an inadequate
             response to previous or current treatment with a TNFα inhibitor given at an approved
             dose for at least 3 months or have stopped treatment due to safety/tolerability
             problems after at least one administration of a TNFα inhibitor.

          -  Subjects who have previously been treated with TNFα inhibitors (investigational or
             approved) will be allowed entry into study after appropriate wash-out period prior to
             randomization

        Exclusion Criteria:

        Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process. -
        Subjects taking high potency opioid analgesics.

          -  Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or
             IL-17 receptor. - Ongoing use of prohibited psoriasis treatments / medications (e.g.,
             topical corticosteroids, UV therapy) at randomization.

          -  Any intramuscular or intravenous or intra-articular corticosteroid treatment within 4
             weeks before randomization.

          -  Subjects who have ever received biologic immunomodulating agents except for those
             targeting TNFα (investigational or approved).

          -  Previous treatment with any cell-depleting therapies including but not limited to
             anti- CD20, investigational agents

          -  Other protocol-defined exclusion criteria do apply