Study Description
The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation.
Interventions
Secukinumab s.c. injection
Eligibility Criteria
Inclusion Criteria:
Signed informed consent must be obtained for adult participants before any assessment is performed. Written informed assent and parental permission (age as per local law) must be obtained for pediatric participants before any assessment is performed. If participants reach age of consent (age as per local law) during the study, they will need to also sign the corresponding study informed consent(s).
Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
Participant has completed treatment per protocol in a Novartis study of secukinumab (unless otherwise specified in a parent study protocol). Participants, who derive benefit from the treatment with secukinumab but have not completed the treatment in certain parent studies, due to parent study termination by Novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (technical / administrative reasons).
Participant is deriving benefit from secukinumab, investigator believes he/she would continue to derive benefit from secukinumab and the benefit outweighs the risk, based on the investigator's judgement.
Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/or reimbursement guidelines.
Exclusion Criteria:
Participant has prematurely discontinued study treatment in the parent protocol.
Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., in European Union (EU) 20 weeks).
Study Location
Novartis Investigative Site
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Rio de Janeiro,20241-180,Brazil
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Vitoria,ES,29055 450,Brazil
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Salvador,BA,40150 150,Brazil
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Juiz de Fora,MG,36010 570,Brazil
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Sao Jose do Rio Preto,15090 000,Brazil
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São Paulo,SP,01244-030,Brazil
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Sao Paulo,SP,04266 010,Brazil
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Sofia,1431,Bulgaria
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Sofia,1784,Bulgaria
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Plovdiv,4002,Bulgaria
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Yangzhou,Jiangsu,225001,China
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Shanghai,200040,China
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Linyi,Shandong,276000,China
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Beijing,Beijing,100044,China
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Pingxiang,Jiangxi,337000,China
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Zhejiang,315016,China
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Shanghai,200050,China
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Beijing,100000,China
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Jinan,250012,China
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Shanghai,200127,China
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Nanchang,Jiangxi,330006,China
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Beijing,100730,China
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Tianjin,300052,China
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Chang Chun,Jilin,130021,China
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Hefei,Anhui,230001,China
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Shantou,Guangdong,515041,China
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Bengbu,233004,China
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Nanjing,Jiangsu,210008,China
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Guang Zhou,Guang Dong Province,510120,China
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Changsha,Hunan,410011,China
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Hefei,Anhui,230601,China
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Shenzhen,Guangdong,518020,China
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Nanjing,Jiangsu,210009,China
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Wuhan,Hubei,430030,China
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Guangzhou,Guangdong,510080,China
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Chengdu,Sichuan,610041,China
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Hohhot,Inner Mongolia,10050,China
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Xiamen,Fujian,361001,China
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Guangzhou,Guangdong,510515,China
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KunMing,Yun Nan,650000,China
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Urumqi,Xinjiang,830001,China
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Baotou,Inner Mongolia,014010,China
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Chongqing,Chongqing,400010,China
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Ibague,Tolima,730006,Colombia
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Cundinamarca,111121,Colombia
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Bucaramanga,Santander,0001,Colombia
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Bogota,110221,Colombia
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Hradec Kralove,CZE,500 05,Czech Republic
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Brno Bohunice,625 00,Czech Republic
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Praha 5,150 06,Czech Republic
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Brno-Zidonice,CZE,61500,Czech Republic
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Prague 4,14059,Czech Republic
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Uherske Hradiste,686 01,Czech Republic
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Praha 11,14900,Czech Republic
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Ostrava,Czech Republic,772 00,Czech Republic
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Praha 2,128 50,Czech Republic
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Guatemala,01001,Guatemala
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Guatemala,01009,Guatemala
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Guatemala,01010,Guatemala
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Culiacan,MEX,80000,Mexico
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Metepec,Estado De Mexico,52140,Mexico
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Guadalajara,Jalisco,44160,Mexico
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Warszawa,02-962,Poland
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Poznan,60-218,Poland
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Wroclaw,53-224,Poland
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Krakow,Malopolskie,30-727,Poland
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Torun,87-100,Poland
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Bialystok,15-351,Poland
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Krakow,30 002,Poland
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Sochaczew,96-500,Poland
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Panorama,Western Cape,7500,South Africa
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Stellenbosch,7600,South Africa
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Valencia,46026,Spain
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Santiago De Compostela,Galicia,15706,Spain
Dawes Fretzin Clinical Rea Group .
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Indianapolis,Joan Prusa (+1 317 516 5030#102) email: [email protected] -- Scott Fretzin,46256 - Indiana,United States
West Tennessee Research Institute
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Jackson,Kim Smith (731-664-7824) email: [email protected] -- Jacob A. Aelion,38305 - Tennessee,United States
Denver Arthritis Clinic .
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Denver,Kaitlyn Arce (+1 303 394 2828) email: [email protected] -- Christopher Ryan Antolini,80230 - Colorado,United States
Homestead Associates in Research Inc
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Miami,Jhenny Grullon (305-246-0873) email: [email protected] -- Gilberto Seco,33032 - Florida,United States
Oregon Health Sciences University
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Portland,(503-494-5742) -- Atul Deodhar,97239 - Oregon,United States
Ahmed Arif Medical Research Center
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Grand Blanc,(810-953-8700) -- Ali Karrar,48439 - Michigan,United States
Integral Rheumatology and Immunology Specialists IRIS
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Plantation,(954-476-2338) -- Guillermo Valenzuela,33324 - Florida,United States
Precn Comprehensive Clnl Rsch Solns
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San Leandro,(510-357-1040) -- Suneet Grewal,94578 - California,United States
Athritis, Rheumatology and Back Disease Associates, PA .
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Voorhees,Jessica Reibel (856-424-5005) email: [email protected] -- Joshua B Sundhar,08043 - New Jersey,United States
Klein and Associates Rheumatology
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Cumberland,Ladonna Ortt email: [email protected] -- Steven J Klein,21740 - Maryland,United States
Providence Medical Foundation .
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Fullerton,Baudelia Ruvalcaba email: [email protected] -- Shirley Pang,92835 - California,United States
Center for Rheumatology Research Rheumatology
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West Hills,Lauren Jackson email: [email protected] -- Nazanin Firooz,91307 - California,United States
Medvin Clinical Research .
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Van Nuys,Samy Metyas,91405 - California,United States
Purushotham Akther and Roshan Kotha MD Inc
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La Mesa,Eva Duran (619-229-1995) email: [email protected] -- Roshan Kotha,91942 - California,United States
Conquest Research
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Winter Park,Natalie Pritchard (407-353-2402) email: [email protected] -- Anand Patel,32789 - Florida,United States
Southwest Rheumatology Research LLC
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Mesquite,Joan Mendoza (972-288-2600) email: [email protected] -- Atul K K. Singhal,75150 - Texas,United States
Worldwide Contacts
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