Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.
NCT ID: NCT01770379
Last Updated: 2016-07-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
242 participants
INTERVENTIONAL
2012-10-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Secukinumab 75 mg
Secukinumab 75 mg s.c.
Secukinumab (AIN457)
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17)
Secukinumab 150 mg
Secukinumab 150 mg s.c.
Secukinumab (AIN457)
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17)
Placebo
Placebo patients will be re-randomized 1:1 to secukinumab 75 or 150mg s.c. (non-responders at Week 16 will be re-assigned to new treatment at Week 16; responders at Week 16 will be re-assigned to new treatment at Week 24)
Placebo
Interventions
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Secukinumab (AIN457)
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17)
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current RA functional status class IV according to the ACR 1991 revised criteria •Previous use of secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor and/or any history of hypersensitivity to secukinumab or its excipient or to drugs of similar chemical classes. Other protocol-defined inclusion/exclusion criteria may apply
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Peoria, Arizona, United States
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Santa Monica, California, United States
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Upland, California, United States
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Miami, Florida, United States
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Pembroke Pines, Florida, United States
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Zephyrhills, Florida, United States
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Cumberland, Maryland, United States
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Edina, Minnesota, United States
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Tupelo, Mississippi, United States
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Lees Summit, Missouri, United States
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St Louis, Missouri, United States
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Reno, Nevada, United States
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Albuquerque, New Mexico, United States
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Zanesville, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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North Charleston, South Carolina, United States
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Rapid City, South Dakota, United States
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Jackson, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Benbrook, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Mesquite, Texas, United States
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Mar del Plata, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Salvador, Estado de Bahia, Brazil
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Juiz de Fora, Minas Gerais, Brazil
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Curitiba, Paraná, Brazil
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São Paulo, São Paulo, Brazil
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Cali, Colombia, Colombia
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Bogotá, , Colombia
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Uherské Hradiště, Czech Republic, Czechia
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Prague, , Czechia
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Santo Domingo, Republica Dominicana, Dominican Republic
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Hanover, Germany, Germany
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Bad Doberan, , Germany
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Göttingen, , Germany
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Hamburg, , Germany
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Magdeburg, , Germany
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Pirna, , Germany
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Athens, GR, Greece
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Heraklion, GR, Greece
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Athens, , Greece
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Guatemala City, Departamento de Guatemala, Guatemala
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Secunderabad, Andhra Pradesh, India
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Pune, Maharashtra, India
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Pune, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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Jaipur, Rajasthan, India
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Bergamo, BG, Italy
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Catania, CT, Italy
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Roma, RM, Italy
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Verona, VR, Italy
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Bologna, , Italy
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Fukuoka, Fukuoka, Japan
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Takasaki, Gunma, Japan
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Hiroshima, Hiroshima, Japan
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Yokohama, Kanagawa, Japan
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Kumamoto, Kumamoto, Japan
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Miyagi-gun, Miyagi, Japan
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Nagano, Nagano, Japan
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Sasebo, Nagasaki, Japan
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Setouchi, Okayama-ken, Japan
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Kawachi-Nagano, Osaka, Japan
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Tokorozawa, Saitama, Japan
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Hamamatsu, Shizuoka, Japan
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Toyama, Toyama, Japan
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Panama City, Provincia de Panamá, Panama
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Panama City, Provincia de Panamá, Panama
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Lisbon, Portugal, Portugal
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Lisbon, Portugal, Portugal
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Panorama, Western Cape, South Africa
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Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Countries
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References
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Huang Y, Fan Y, Liu Y, Xie W, Zhang Z. Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials. Clin Rheumatol. 2019 Oct;38(10):2765-2776. doi: 10.1007/s10067-019-04595-1. Epub 2019 May 14.
Other Identifiers
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2011-006058-94
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457F2311
Identifier Type: -
Identifier Source: org_study_id
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