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:
1. 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).
2. Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
3. 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).
4. 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.
5. Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/or reimbursement guidelines.
Exclusion Criteria:
1. Participant has prematurely discontinued study treatment in the parent protocol.
2. 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).
Novartis Investigative Site
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Sao Paulo,SP,01244-030,Brazil
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Sao Paulo,SP,04266 010,Brazil
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Rio de Janeiro,20241-180,Brazil
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Sao Jose do Rio Preto,15090 000,Brazil
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Salvador,BA,40150 150,Brazil
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Vitoria,ES,29055 450,Brazil
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Juiz de Fora,MG,36010 570,Brazil
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Sofia,1784,Bulgaria
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Plovdiv,4002,Bulgaria
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Sofia,1431,Bulgaria
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Pingxiang,Jiangxi,337000,China
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Zhejiang,315016,China
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Baotou,Inner Mongolia,014010,China
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Beijing,100000,China
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Guangzhou,Guangdong,510080,China
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Chang Chun,Jilin,130021,China
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Hefei,Anhui,230001,China
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Hohhot,Inner Mongolia,10050,China
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Jinan,250012,China
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Bengbu,233004,China
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Guangzhou,Guangdong,510515,China
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Linyi,Shandong,276000,China
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Hefei,Anhui,230601,China
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Nanjing,Jiangsu,210008,China
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Shanghai,200040,China
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Shantou,Guangdong,515041,China
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Chengdu,Sichuan,610041,China
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Beijing,Beijing,100044,China
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Nanjing,Jiangsu,210009,China
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Shanghai,200050,China
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Shenzhen,Guangdong,518020,China
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Urumqi,Xinjiang,830001,China
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Chongqing,Chongqing,400010,China
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Yangzhou,Jiangsu,225001,China
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Shanghai,200127,China
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Wuhan,Hubei,430030,China
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KunMing,Yun Nan,650000,China
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Xiamen,Fujian,361001,China
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Nanchang,Jiangxi,330006,China
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Tianjin,300052,China
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Changsha,Hunan,410011,China
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Wenzhou,Zhejiang,325000,China
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Guang Zhou,Guangdong,510120,China
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Bucaramanga,Santander,0001,Colombia
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Ibague,Tolima,730006,Colombia
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Bogota,110221,Colombia
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Cundinamarca,111121,Colombia
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Uherske Hradiste,686 01,Czechia
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Hradec Kralove,CZE,500 05,Czechia
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Brno Bohunice,625 00,Czechia
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Praha 11,14900,Czechia
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Praha 2,128 50,Czechia
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Praha 4,140 59,Czechia
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Ostrava,Czech Republic,772 00,Czechia
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Praha 5,150 06,Czechia
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Brno-Zidonice,CZE,61500,Czechia
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Guatemala,01001,Guatemala
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Guatemala,01009,Guatemala
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Guatemala City,01010,Guatemala
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Nashik,Maharashtra,422101,India
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Torun,87-100,Poland
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Warszawa,02 637,Poland
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Bialystok,15-351,Poland
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Sochaczew,96-500,Poland
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Saint Petersburg,197198,Russian Federation
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Kazan,420064,Russian Federation
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Yaroslavl,150003,Russian Federation
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Moscow,119296,Russian Federation
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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
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Madrid,28046,Spain
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Basel,4031,Switzerland
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Bern,3010,Switzerland
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St Gallen,9007,Switzerland
Southwest Rheum Rsrch LLC
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Mesquite,Texas,75150,United States
Atul K Singhal
Center for Rheumatology Research
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West Hills,California,91307,United States
Nazanin Firooz
Lauren Jackson
Ahmed Arif Medical Research Center
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Grand Blanc,Michigan,48439,United States
Ali Karrar
Homestead Assoc In Research Inc
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Homestead,Florida,33033,United States
Gilberto Seco
Altoona Center for Clin Res
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Duncansville,Pennsylvania,16635,United States
Alan J Kivitz
Denver Arthritis Clinic
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Denver,Colorado,80230,United States
Christopher Ryan Antolini
Rheumatology Pulmonary Clinic
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Beckley,West Virginia,25801,United States
Wassim S Saikali
Oregon Health Sciences University
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Portland,Oregon,97239,United States
Atul Deodhar
Integral Rheumatology and Immunology Specialists IRIS
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Plantation,Florida,33324,United States
Guillermo Valenzuela
Accurate Clinical Research Inc
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San Antonio,Texas,78229,United States
Philip Waller
Viet Ta
FL Medical Clinic Orlando Health
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Zephyrhills,Florida,33542,United States
Natalie Faith
Purushotham Akther and Roshan Kotha MD Inc
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La Mesa,California,91942,United States
Roshan Kotha
West Tennessee Research Institute
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Jackson,Tennessee,38305,United States
Jacob A. Aelion
Medvin Clinical Research
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Van Nuys,California,91405,United States
Samy Metyas
Illinois Bone And Joint Institute
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Hinsdale,Illinois,60521,United States
Angela R Crowley
Swarnika Sampat
Precn Comprehensive Clnl Rsch Solns
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San Leandro,California,94578,United States
Suneet Grewal
Dawes Fretzin Clinical Rea Group
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Indianapolis,Indiana,46256,United States
Scott Fretzin
Worldwide Contacts
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