Psoriasis Clinical Trial
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis
Summary
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
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.
Other protocol-defined inclusion criteria do apply.
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.
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There are 64 Locations for this study
Mesa Arizona, 85202, United States
Upland California, 91786, United States
Denver Colorado, 80230, United States
Palm Harbor Florida, 34684, United States
Sarasota Florida, 34239, United States
Peoria Illinois, 61602, United States
Shreveport Louisiana, 71101, United States
Saint Clair Shores Michigan, 48081, United States
Saint Louis Missouri, 63117, United States
Lincoln Nebraska, 68516, United States
Albany New York, 12206, United States
Oklahoma City Oklahoma, 73103, United States
Duncansville Pennsylvania, 16635, United States
Charleston South Carolina, 29460, United States
Greenville South Carolina, 29601, United States
Mesquite Texas, 75150, United States
Burlington Vermont, 05401, United States
Seattle Washington, 98104, United States
Seattle Washington, 98122, United States
Kogarah New South Wales, 2217, Australia
Maroochydore Queensland, 4558, Australia
Hobart Tasmania, 7000, Australia
Malvern East Victoria, 3145, Australia
Aalst , 9300, Belgium
Bruxelles , 1070, Belgium
Bruxelles , 1200, Belgium
Yvoir , 5530, Belgium
Plovdiv , 4000, Bulgaria
Sofia , 1431, Bulgaria
Victoria British Columbia, V8V 3, Canada
Winnipeg Manitoba, R3A 1, Canada
Pointe-Claire Quebec, H9R 3, Canada
Trois Rivieres Quebec, G8Z 1, Canada
Bruntal Czech Republic, 792 0, Czechia
Hlucin Czech Republic, 748 0, Czechia
Praha 2 Czech Republic, 128 5, Czechia
Praha 4 Czech Republic, 140 0, Czechia
Uherske Hradiste Czech Republic, 686 0, Czechia
Le Mans , 72037, France
Montpellier , 34195, France
Erlangen , 91054, Germany
Frankfurt am Main , 60528, Germany
Gottingen , 37075, Germany
Hamburg , 20095, Germany
Hamburg , 22415, Germany
Herne , 44649, Germany
Magdeburg , 39110, Germany
Nienburg , 31582, Germany
Rozzano MI, 20089, Italy
Verona VR, 37126, Italy
Bologna , 40138, Italy
Bialystok , 15-46, Poland
Dopiewo , 62 06, Poland
Elblag , 82-30, Poland
Lodz , 90-26, Poland
Poznan , 60-21, Poland
Poznan , 61 11, Poland
Ekaterinburg , 62002, Russian Federation
Ekaterinburg , 62003, Russian Federation
Petrozavodsk , 18501, Russian Federation
St Petersburg , 19006, Russian Federation
Yaroslavl , 15000, Russian Federation
Stockholm , SE-17, Sweden
Leytonstone London, E11 1, United Kingdom
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