Spots Global Cancer Trial Database for Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents (CAIN457F2309 and CAIN457F2309E1)
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Trial Identification
Brief Title: Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents (CAIN457F2309 and CAIN457F2309E1)
Official Title: A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents (CAIN457F2309) and A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2309E1)
Study ID: NCT01350804
Conditions
Study Description
Brief Summary: The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo or abatacept (active comparator). The core study was completed. However, the extension study was prematurely terminated after the primary endpoint analysis of the core study at week 24 had demonstrated numerically higher efficacy for the active comparator abatacept compared to secukinumab.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Novartis Investigative Site, Anniston, Alabama, United States
Novartis Investigative Site, Vestavia, Alabama, United States
Novartis Investigative Site, Freemont, California, United States
Novartis Investigative Site, Pomona, California, United States
Novartis Investigative Site, Upland, California, United States
Novartis Investigative Site, Van Nuys, California, United States
Novartis Investigative Site, Bridgeport, Connecticut, United States
Novartis Investigative Site, Aventura, Florida, United States
Novartis Investigative Site, Boca Raton, Florida, United States
Novartis Investigative Site, Hialeah, Florida, United States
Novartis Investigative Site, Miami, Florida, United States
Novartis Investigative Site, Orlando, Florida, United States
Novartis Investigative Site, Palm Harbor, Florida, United States
Novartis Investigative Site, Pembroke Pines, Florida, United States
Novartis Investigative Site, Pensacola, Florida, United States
Novartis Investigative Site, Plantation, Florida, United States
Novartis Investigative Site, Sarasota, Florida, United States
Novartis Investigative Site, Tampa, Florida, United States
Novartis Investigative Site, Coeur d'Alene, Idaho, United States
Novartis Investigative Site, Morton Grove, Illinois, United States
Novartis Investigative Site, Springfield, Illinois, United States
Novartis Investigative Site, Wichita, Kansas, United States
Novartis Investigative Site, Bowling Green, Kentucky, United States
Novartis Investigative Site, Lexington, Kentucky, United States
Novartis Investigative Site, Boston, Massachusetts, United States
Novartis Investigative Site, Lansing, Michigan, United States
Novartis Investigative Site, Eagan, Minnesota, United States
Novartis Investigative Site, Kansas City, Missouri, United States
Novartis Investigative Site, Richmond Heights, Missouri, United States
Novartis Investigative Site, Omaha, Nebraska, United States
Novartis Investigative Site, Cincinnati, Ohio, United States
Novartis Investigative Site, Zanesville, Ohio, United States
Novartis Investigative Site, Oklahoma City, Oklahoma, United States
Novartis Investigative Site, Jackson, Tennessee, United States
Novartis Investigative Site, Kingsport, Tennessee, United States
Novartis Investigative Site, Austin, Texas, United States
Novartis Investigative Site, Carrollton, Texas, United States
Novartis Investigative Site, Dallas, Texas, United States
Novartis Investigative Site, Dallas, Texas, United States
Novartis Investigative Site, Houston, Texas, United States
Novartis Investigative Site, Sugar Land, Texas, United States
Novartis Investigative Site, Waco, Texas, United States
Novartis Investigative Site, Spokane, Washington, United States
Novartis Investigative Site, Clarksburg, West Virginia, United States
Novartis Investigative Site, Curitiba, PR, Brazil
Novartis Investigative Site, Rio de Janeiro, RJ, Brazil
Novartis Investigative Site, Porto Alegre, RS, Brazil
Novartis Investigative Site, Sao Paulo, SP, Brazil
Novartis Investigative Site, Sao Paulo, SP, Brazil
Novartis Investigative Site, São Paulo, SP, Brazil
Novartis Investigative Site, Plovdiv, , Bulgaria
Novartis Investigative Site, Plovdiv, , Bulgaria
Novartis Investigative Site, Russe, , Bulgaria
Novartis Investigative Site, Sevlievo, , Bulgaria
Novartis Investigative Site, Sofia, , Bulgaria
Novartis Investigative Site, Sofia, , Bulgaria
Novartis Investigative Site, Sofia, , Bulgaria
Novartis Investigative Site, St. John's, Newfoundland and Labrador, Canada
Novartis Investigative Site, Sainte-Foy, Quebec, Canada
Novartis Investigative Site, Trois-Rivieres, Quebec, Canada
Novartis Investigative Site, Bogotá, Cundinamarca, Colombia
Novartis Investigative Site, Barranquilla, , Colombia
Novartis Investigative Site, Bogotá, , Colombia
Novartis Investigative Site, Bruntal, , Czech Republic
Novartis Investigative Site, Ostrava, , Czech Republic
Novartis Investigative Site, Uherske Hradiste, , Czech Republic
Novartis Investigative Site, Zlin, , Czech Republic
Novartis Investigative Site, Bordeaux Cedex, , France
Novartis Investigative Site, Cahors, , France
Novartis Investigative Site, Montpellier, , France
Novartis Investigative Site, Paris, , France
Novartis Investigative Site, Toulouse, , France
Novartis Investigative Site, Aachen, , Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Cottbus, , Germany
Novartis Investigative Site, Erlangen, , Germany
Novartis Investigative Site, Essen, , Germany
Novartis Investigative Site, Gommern, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Koeln, , Germany
Novartis Investigative Site, Leipzig, , Germany
Novartis Investigative Site, Magdeburg, , Germany
Novartis Investigative Site, Osnabrück, , Germany
Novartis Investigative Site, Zerbst, , Germany
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Gyor, , Hungary
Novartis Investigative Site, Gyula, , Hungary
Novartis Investigative Site, Szolnok, , Hungary
Novartis Investigative Site, Valeggio Sul Mincio, (vr), Italy
Novartis Investigative Site, Firenze, FI, Italy
Novartis Investigative Site, Genova, GE, Italy
Novartis Investigative Site, Perugia, PG, Italy
Novartis Investigative Site, Siena, SI, Italy
Novartis Investigative Site, Mexicali, Baja California, Mexico
Novartis Investigative Site, Mexico, Distrito Federal, Mexico
Novartis Investigative Site, Mexico, Distrito Federal, Mexico
Novartis Investigative Site, Guadalajara, Jalisco, Mexico
Novartis Investigative Site, Monterrey, Nuevo Leon, Mexico
Novartis Investigative Site, Culiacan, Sinaloa, Mexico
Novartis Investigative Site, Iasi, , Romania
Novartis Investigative Site, Korolev, , Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Petrozavodsk, , Russian Federation
Novartis Investigative Site, Saint-Petersburg, , Russian Federation
Novartis Investigative Site, Tula, , Russian Federation
Novartis Investigative Site, Banska Bystrica, Slovak Republic, Slovakia
Novartis Investigative Site, Piestany, , Slovakia
Novartis Investigative Site, Malaga, Andalucia, Spain
Novartis Investigative Site, Sevilla, Andalucia, Spain
Novartis Investigative Site, Sabadell, Barcelona, Spain
Novartis Investigative Site, Santander, Cantabria, Spain
Novartis Investigative Site, La Coruna, Galicia, Spain
Novartis Investigative Site, Santiago de Compostela, Galicia, Spain
Novartis Investigative Site, Madrid, , Spain
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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