Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment

Launched by NOVARTIS PHARMACEUTICALS · Nov 16, 2020

Keywords

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Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Diagnosis of PsA as classified by CASPAR criteria for at least 6 months before randomization.
• • Active PsA at baseline defined as ≥ 3 tender joints out of 68 and ≥ 3 swollen joints out of 66 (dactylitis of a digit counts as one joint each).
• • Inadequate response or intolerance to previous or current treatment with at least one TNFα inhibitor
• • Inadequate response or intolerance to conventional disease modifying anti-rheumatic drugs (cDMARDs)
• • Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm diameter and/or nail changes consistent with psoriasis and/or documented history of plaque psoriasis.
• • Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) antibodies negative at screening.
• Key Exclusion Criteria:
• • Pregnant or nursing women,
• • Previous exposure to secukinumab, ustekinumab or any other biologic drug directly targeting IL-17, IL-17 receptor, IL-12 or IL-23.
• • Patients for whom the use of secukinumab or ustekinumab is contraindicated.
• • Use of any other investigational drug. Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents
• • Evidence of ongoing infectious or malignant process
• • Subjects receiving high potency opioid analgesics
• • Ongoing use of prohibited psoriasis treatments/medications
• • Other protocol-defined inclusion/exclusion criteria may apply