Psoriasis Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

414

Study ID:

NCT01989468

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 77 Locations for this study

See Locations Near You

Novartis Investigative Site
Aventura Florida, 33180, United States
Novartis Investigative Site
Palm Harbor Florida, 34684, United States
Novartis Investigative Site
Sarasota Florida, 34239, United States
Novartis Investigative Site
Indianapolis Indiana, 46256, United States
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Bowling Green Kentucky, 42101, United States
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Saint Louis Missouri, 63117, United States
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Freehold New Jersey, 07728, United States
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Albany New York, 12206, United States
Novartis Investigative Site
Duncansville Pennsylvania, 16635, United States
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Austin Texas, 78731, United States
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Mesquite Texas, 75150, United States
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Wenatchee Washington, 98801, United States
Novartis Investigative Site
Kogarah New South Wales, 2217, Australia
Novartis Investigative Site
Maroochydore Queensland, 4558, Australia
Novartis Investigative Site
Hobart Tasmania, 7000, Australia
Novartis Investigative Site
Malvern East Victoria, 3145, Australia
Novartis Investigative Site
Sofia , 1413, Bulgaria
Novartis Investigative Site
Sofia , 1431, Bulgaria
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Sofia , 1505, Bulgaria
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Veliko Tarnovo , 5000, Bulgaria
Novartis Investigative Site
Victoria British Columbia, V8V 3, Canada
Novartis Investigative Site
Winnipeg Manitoba, R3A 1, Canada
Novartis Investigative Site
Toronto Ontario, M9W 4, Canada
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Trois Rivieres Quebec, G8Z 1, Canada
Novartis Investigative Site
Bruntal Czech Republic, 792 0, Czechia
Novartis Investigative Site
Praha 2 Czech Republic, 128 5, Czechia
Novartis Investigative Site
Uherske Hradiste Czech Republic, 686 0, Czechia
Novartis Investigative Site
Aachen , 52064, Germany
Novartis Investigative Site
Berlin , 10117, Germany
Novartis Investigative Site
Chemnitz , 09130, Germany
Novartis Investigative Site
Erlangen , 91056, Germany
Novartis Investigative Site
Gommern , 39245, Germany
Novartis Investigative Site
Hamburg , 20095, Germany
Novartis Investigative Site
Hamburg , 22081, Germany
Novartis Investigative Site
Hamburg , 22415, Germany
Novartis Investigative Site
Hannover , 30625, Germany
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Hildesheim , 31134, Germany
Novartis Investigative Site
Magdeburg , 39110, Germany
Novartis Investigative Site
Zerbst , 39261, Germany
Novartis Investigative Site
Bologna BO, 40138, Italy
Novartis Investigative Site
Catania CT, 95100, Italy
Novartis Investigative Site
Genova GE, 16132, Italy
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Rozzano MI, 20089, Italy
Novartis Investigative Site
Reggio Emilia RE, 42123, Italy
Novartis Investigative Site
Torino TO, 10128, Italy
Novartis Investigative Site
Verona VR, 37126, Italy
Novartis Investigative Site
Amsterdam , 1105 , Netherlands
Novartis Investigative Site
Heerlen , 6419 , Netherlands
Novartis Investigative Site
Rotterdam , 3079 , Netherlands
Novartis Investigative Site
Caguas , 00725, Puerto Rico
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Ponce , 00716, Puerto Rico
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Chelyabinsk , 45407, Russian Federation
Novartis Investigative Site
Ekaterinburg , 62002, Russian Federation
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Moscow , 11552, Russian Federation
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Rostov on Don , 34402, Russian Federation
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Saratov , 41005, Russian Federation
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Sestroretsk , 19770, Russian Federation
Novartis Investigative Site
Yaroslavl , 15000, Russian Federation
Novartis Investigative Site
Sevilla Andalucia, 41009, Spain
Novartis Investigative Site
Santander Cantabria, 39008, Spain
Novartis Investigative Site
Barcelona Catalunya, 08036, Spain
Novartis Investigative Site
La Coruna Galicia, 15006, Spain
Novartis Investigative Site
Fribourg , 1708, Switzerland
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St Gallen , CH 90, Switzerland
Novartis Investigative Site
London England, E11 1, United Kingdom
Novartis Investigative Site
Salford Manchester, M6 8H, United Kingdom
Novartis Investigative Site
Cannock Staffordshire, WS11 , United Kingdom
Novartis Investigative Site
Stoke on Trent Staffordshire, ST6 7, United Kingdom
Novartis Investigative Site
Barnsley , S75 2, United Kingdom
Novartis Investigative Site
Eastbourne , BN21 , United Kingdom
Novartis Investigative Site
Harrogate , HG2 7, United Kingdom
Novartis Investigative Site
Hull , HU3 2, United Kingdom
Novartis Investigative Site
London , NW3 2, United Kingdom
Novartis Investigative Site
London , SE1 9, United Kingdom
Novartis Investigative Site
Manchester , M23 9, United Kingdom
Novartis Investigative Site
Torquay , TQ2 7, United Kingdom
Novartis Investigative Site
Tyne And Wear , NE29 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

414

Study ID:

NCT01989468

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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