Study of Power Doppler Ultrasound (PDUS) to Measure Response of Secukinumab Treatment in Patients With Active Psoriatic Arthritis (PsA)
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: AIN457 (secukinumab); Placebo
Intervention description: Is a recombinant monoclonal antibody which neutralizes the activity of IL-17A, and has been shown to be effective in treating patients with moderate-to-severe plaque psoriasis.
Secukinumab 150 mg provided in 1 mL pre filled syringes (PFS) for s.c. injection. The 300 mg dose was administered as 2 × PFS injections.; Secukinumab placebo was provided in a 1 mL PFS for s.c. injection.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 166.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Power Doppler Ultrasonography; Psoriatic Arthritis; Enthesitis; Synovitis; Outcome Measures in Rheumatology; Spondyloarthritis Research Consortium of Canada; active psoriatic arthritis; secukinumab; Arthritis; GLOESS; monoclonal antibody; PsA

Summary:

      This study was designed to leverage the sensitivity of ultrasonography available in clinical
      practice setting to better describe the time course of response to secukinumab (150 mg and
      300 mg) on joint synovitis and enthesitis in PsA patients with an inadequate response to
      non-biologic DMARDs. PDUS changes in joint synovitis will be assessed using the global
      Outcome Measures in Rheumatology (OMERACT)-European League against Rheumatism (EULAR)
      synovitis score (GLOESS) and changes in joint enthesitis were assessed using the OMERACT
      enthesitis score.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient must be able to understand and communicate with the Investigator and comply
             with the requirements of the study and must provide written, signed and dated informed
             consent before any study assessment is performed.

          2. Male or female patients at least 18 years of age.

          3. Diagnosis of PsA as per CASPAR with active PsA for at least 6 months and a TJC ≥ 3 of
             78 and SJC ≥ 3 of 76 at Baseline.

          4. Patients must have a total synovitis PDUS score ≥ 2 and inflammation related to PD
             signal ≥ 1 for at least 2 (affected joints as observed via PDUS) of 48 joints at the
             Screening visit and at the Baseline visit (before infusion).

          5. At least 1 clinically-involved enthesitis site at Screening and at the Baseline visit
             (before infusion) defined by SPARCC index different from 0.

        Exclusion Criteria:

          1. 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.

          2. Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or
             IL-17 receptor.

          3. Any change in the dose of oral corticosteroids in the last 4 weeks prior to the
             Baseline visit or use of i.v. intramuscular or intra-articular corticosteroid during
             the last 4 weeks prior to the enrollment visit.

          4. Patients who have previously been treated with TNFα inhibitors (investigational or
             approved).

          5. History of hypersensitivity to the study drug or its excipients or to drugs of similar
             classes.

          6. 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).

          7. Prohibited psoriasis treatments/medications with topical corticosteroids in the last 4
             weeks prior to randomization.

          8. Pregnant or nursing (lactating) women.