Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis (PsA) After 16 Weeks of Treatment Compared to Placebo

Completed · Phase 4 · Has a placebo group

Conditions studied: Psoriatic Arthritis

In brief

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

Key facts

Study ID

NCT02798211

Run by

Novartis Pharmaceuticals

People needed

258

Starts

2016-06-27

Expected to finish

2018-12-05

Last updated by the study team

2021-10-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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/or anti-CCP antibodies negative at screening
• A target skin psoriatic lesion and a PASI score of 1 or greater

You may not qualify if…

• Chest X-ray with evidence of ongoing infectious or malignant process
• Patients who ever received biologic immunomodulating agents including those targeting TNFα, IL-6 and IL-12/23 investigational or approved

Where it is running

• Novartis Investigative Site — Little Rock, Arkansas, United States
• Novartis Investigative Site — El Cajon, California, United States
• Novartis Investigative Site — Fountain Valley, California, United States
• Novartis Investigative Site — La Jolla, California, United States
• Novartis Investigative Site — La Mesa, California, United States
• Novartis Investigative Site — Upland, California, United States
• Novartis Investigative Site — Aventura, Florida, United States
• Novartis Investigative Site — Clearwater, Florida, United States
• Novartis Investigative Site — DeBary, Florida, United States
• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — North Naples, Florida, United States
• Novartis Investigative Site — Palm Harbor, Florida, United States
• Novartis Investigative Site — Pensacola, Florida, United States
• Novartis Investigative Site — Plantation, Florida, United States
• Novartis Investigative Site — Sarasota, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Duluth, Georgia, United States
• Novartis Investigative Site — Baltimore, Maryland, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Worcester, Massachusetts, United States
• Novartis Investigative Site — Battle Creek, Michigan, United States
• Novartis Investigative Site — Kalamazoo, Michigan, United States
• Novartis Investigative Site — Eagan, Minnesota, United States
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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