24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis
Completed · Phase 3 · Has a placebo group
Conditions studied: Psoriatic Arthritis
In brief
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.
Key facts
- Study ID
- NCT01989468
- Run by
- Novartis Pharmaceuticals
- People needed
- 414
- Starts
- 2014-04-10
- Expected to finish
- 2018-03-28
- Last updated by the study team
- 2019-04-16
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.
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 — Palm Harbor, Florida, United States
- Novartis Investigative Site — Sarasota, Florida, United States
- Novartis Investigative Site — Indianapolis, Indiana, United States
- Novartis Investigative Site — Bowling Green, Kentucky, United States
- Novartis Investigative Site — St Louis, Missouri, United States
- Novartis Investigative Site — Freehold, New Jersey, United States
- Novartis Investigative Site — Albany, New York, United States
- Novartis Investigative Site — Duncansville, Pennsylvania, United States
- Novartis Investigative Site — Austin, Texas, United States
- Novartis Investigative Site — Mesquite, Texas, United States
- Novartis Investigative Site — Wenatchee, 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 — Sofia, Bulgaria
- Novartis Investigative Site — Sofia, Bulgaria
- Novartis Investigative Site — Sofia, Bulgaria
- Novartis Investigative Site — Veliko Tarnovo, Bulgaria
- Novartis Investigative Site — Victoria, British Columbia, Canada
- Novartis Investigative Site — Winnipeg, Manitoba, Canada
- Novartis Investigative Site — Toronto, Ontario, Canada
- Novartis Investigative Site — Trois-Rivières, Quebec, Canada
- Novartis Investigative Site — Bruntál, Czech Republic, Czechia
- Novartis Investigative Site — Aventura, Florida, United States
Full record on ClinicalTrials.gov
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