SHS_280166 MEAP CNOV 16113

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis After 16 Weeks of Treatment Compared to Placebo and to Assess the Safety, Tolerability and Efficacy up to 52 Weeks

To demonstrate that the efficacy of secukinumab 300 mg at Week 16 is superior to placebo in adult patients with active PsA based on the proportion of patients achieving an American College of Rheumatology 20 (ACR20) response.

Inclusion Criteria:

•Male or non-pregnant, non-lactating female patients at least 18 years of age
•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
•Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of =2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis

Exclusion Criteria:

•Chest X-ray with evidence of ongoing infectious or malignant process
•Patients who ever received biologic immunomodulating agents including those targeting TNFa, IL-6 and IL-12/23 investigational or approved
Phase IV
NCT02798211
All Other
Rheumatology
Philip Mease, M.D.
Novartis
Sephren Barrow
  • Swedish Medical Center