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

Korábbi kezelés

• Previous exposure to secukinumab, ustekinumab or any other biologic drug directly targeting IL-17, IL-17 receptor, IL-12 or IL-23.
• Use of any other investigational drug. Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents
• Subjects receiving high potency opioid analgesics
• Ongoing use of prohibited psoriasis treatments/medications
  • Other protocol-defined inclusion/exclusion criteria may apply

Más betegség

• Evidence of ongoing infectious or malignant process

Egyéb

• Pregnant or nursing women,
• Patients for whom the use of secukinumab or ustekinumab is contraindicated.

• 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.