24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis

Status:	Completed
Conditions:	Arthritis, Psoriasis
Therapuetic Areas:	Dermatology / Plastic Surgery, Rheumatology
Healthy:	No
Age Range:	18 - Any
Updated:	12/14/2018
Start Date:	April 10, 2014
End Date:	March 28, 2018

A Phase III, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab in Autoinjectors, to Demonstrate Efficacy at 24 Weeks and Long Term Safety and Efficacy up to 3 Years in Subjects With Active Psoriatic Arthritis

The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data,
and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic
Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID),
disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis
factor alpha (TNFα) therapy.

Inclusion Criteria:

- Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for
Psoriatic ARthritis (CASPAR) criteria.

- Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.

- Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.

- Inadequate control of symptoms with NSAID.

Exclusion Criteria:

- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing
infectious or malignant process.

- Subjects taking high potency opioid analgesics.

- Previous exposure to secukinumab or other biologic drug directly targeting
interleukin-17 (IL-17) or IL-17 receptor.

- Ongoing use of prohibited psoriasis treatments / medications.

- Subjects who have ever received biologic immunomodulating agents except for those
targeting TNFα.

- Previous treatment with any cell-depleting therapies.

We found this trial at

sites

Novartis Investigative Site

Freehold, New Jersey 07728

from

Freehold, NJ