Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriatic Arthritis

In brief

This study will assess the efficacy and safety of secukinumab in patients with active psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

Key facts

Study ID

NCT01392326

Run by

Novartis Pharmaceuticals

People needed

606

Starts

2011-09-01

Expected to finish

2014-10-01

Last updated by the study team

2016-02-04

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 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 o plaque psoriasis

You may not qualify if…

• Chest X-ray with evidence of ongoing infectious or malignant process
• Subjects who have previously been treated with more than 3 different TNFα inhibitors
• Subjects taking high potency opioid analgesics
• Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Mesa, Arizona, United States
• Novartis Investigative Site — Paradise Valley, Arizona, United States
• Novartis Investigative Site — Upland, California, United States
• Novartis Investigative Site — Tamarac, Florida, United States
• Novartis Investigative Site — Newnan, Georgia, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Eagan, Minnesota, United States
• Novartis Investigative Site — Richmond Heights, Missouri, United States
• Novartis Investigative Site — Lincoln, Nebraska, United States
• Novartis Investigative Site — Freehold, New Jersey, United States
• Novartis Investigative Site — Charlotte, North Carolina, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Duncansville, Pennsylvania, United States
• Novartis Investigative Site — Johnston, Rhode Island, United States
• Novartis Investigative Site — Columbia, South Carolina, United States
• Novartis Investigative Site — North Charleston, South Carolina, United States
• Novartis Investigative Site — Jackson, Tennessee, United States
• Novartis Investigative Site — Benbrook, Texas, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Mesquite, Texas, United States
• Novartis Investigative Site — Seattle, Washington, United States
• Novartis Investigative Site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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