16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis
Completed · Phase 3 · Has a placebo group
Conditions studied: Arthritis, Psoriatic
In brief
The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active PsA despite current or previous NSAID or DMARD therapy
Key facts
- Study ID
- NCT02294227
- Run by
- Novartis Pharmaceuticals
- People needed
- 341
- Starts
- 2015-05-29
- Expected to finish
- 2017-12-19
- Last updated by the study team
- 2019-07-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Other protocol-defined inclusion criteria do apply.
You may not qualify if…
- 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.
Where it is running
- Novartis Investigative Site — Upland, California, United States
- Novartis Investigative Site — Denver, Colorado, United States
- Novartis Investigative Site — Palm Harbor, Florida, United States
- Novartis Investigative Site — Sarasota, Florida, United States
- Novartis Investigative Site — Peoria, Illinois, United States
- Novartis Investigative Site — Shreveport, Louisiana, United States
- Novartis Investigative Site — Saint Clair Shores, Michigan, United States
- Novartis Investigative Site — St Louis, Missouri, United States
- Novartis Investigative Site — Lincoln, Nebraska, United States
- Novartis Investigative Site — Albany, New York, United States
- Novartis Investigative Site — Oklahoma City, Oklahoma, United States
- Novartis Investigative Site — Duncansville, Pennsylvania, United States
- Novartis Investigative Site — Charleston, South Carolina, United States
- Novartis Investigative Site — Greenville, South Carolina, United States
- Novartis Investigative Site — Mesquite, Texas, United States
- Novartis Investigative Site — Burlington, Vermont, United States
- Novartis Investigative Site — Seattle, Washington, United States
- Novartis Investigative Site — Seattle, Washington, United States
- Novartis Investigative Site — Kogarah, New South Wales, Australia
- Novartis Investigative Site — Maroochydore, Queensland, Australia
- Novartis Investigative Site — Hobart, Tasmania, Australia
- Novartis Investigative Site — Malvern East, Victoria, Australia
- Novartis Investigative Site — Aalst, Belgium
- Novartis Investigative Site — Brussels, Belgium
- Novartis Investigative Site — Mesa, Arizona, United States
Full record on ClinicalTrials.gov
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