Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement

• Status: Completed
• Trial end date: 2019-06-26
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Anti-Inflammatory Agents, Non-Steroidal; Antibodies, Monoclonal

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.