Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Secukinumab (AIN457); Placebo
Intervention description: Secukinumab (AIN457); Placebo PFS for s.c. administration.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 397.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic arthritis, PsA, ACR, CASPAR, PASDAS

Summary:

      This study was to provide 24 - 52 week efficacy, safety and tolerability data to support the
      registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self
      administration in subjects with active PsA despite current or previous NSAID, DMARD and/or
      anti-TNFα therapy. An additional 4 years of long-term efficacy and safety data were collected
      during the post Week 52 period of the study.
    

Eligibility criteria:

        Inclusion Criteria:Patients eligible for inclusion in this study have to fulfill all of the
        following 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 Baseline ≥3 tender joints out of 78 and
             ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)

          -  Rheumatoid factor and anti-CCP antibodies negative at screening

          -  Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or
             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 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.

        Exclusion Criteria:Patients fulfilling any of the following criteria are not eligible for
        inclusion in this study:

          -  Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process,
             obtained within 3 months prior to screening and evaluated by a qualified physician

          -  Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone,
             morphine)

          -  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. The following wash out periods need to
             be observed:

          -  Oral or topical retinoids 4 weeks

          -  Photochemotherapy (e.g. PUVA) 4 weeks

          -  Phototherapy (UVA or UVB) 2 weeks

          -  Topical skin treatments (except in face, scalp and genital area during screening, only
             corticosteroids with mild to moderate potency) 2 weeks

          -  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 (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3,
             anti-CD19)