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
Recruiting
Ningbo,Zhejiang,315016,China
Novartis Investigative Site
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Ürümqi,Xinjiang,830001,China
Novartis Investigative Site
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Hefei,Anhui,230601,China
Novartis Investigative Site
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Wuhan,Hubei,430030,China
Novartis Investigative Site
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Yangzhou,Jiangsu,225001,China
Novartis Investigative Site
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Chengdu,Sichuan,610041,China
Novartis Investigative Site
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Wenzhou,Zhejiang,325000,China
Novartis Investigative Site
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Beijing,100000,China
Novartis Investigative Site
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Shanghai,200040,China
Novartis Investigative Site
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Kunming,Yunnan,650000,China
Novartis Investigative Site
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Bucaramanga,Santander Department,680003,Colombia
Novartis Investigative Site
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Prague,150 06,Czechia
Novartis Investigative Site
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Brno,625 00,Czechia
Novartis Investigative Site
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Uherské Hradiště,686 01,Czechia
Novartis Investigative Site
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Brno-Zidonice,CZE,61500,Czechia
Novartis Investigative Site
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Ostrava,Czech Republic,772 00,Czechia
Novartis Investigative Site
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Prague,128 00,Czechia
Novartis Investigative Site
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Prague,148 00,Czechia
Novartis Investigative Site
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Prague,140 59,Czechia
Novartis Investigative Site
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Guatemala City,01001,Guatemala
Novartis Investigative Site
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Guatemala City,01009,Guatemala
Novartis Investigative Site
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Bialystok,15-351,Poland
Novartis Investigative Site
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Torun,87-100,Poland
Novartis Investigative Site
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Krakow,30-002,Poland
Novartis Investigative Site
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Bydgoszcz,85-168,Poland
Novartis Investigative Site
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Saint Petersburg,197198,Russia
Novartis Investigative Site
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Madrid,28046,Spain
Novartis Investigative Site
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Madrid,28009,Spain
Overlake Arthritis and Osteoporosis
Recruiting
Bellevue,Washington,98004,United States
Arinola Dada
Varsha Sridhar
Accurate Clinical Research Inc
Recruiting
San Antonio,Texas,78229,United States
Philip Waller
Yanet Martinez
Rheumatology Associates of South Florida
Recruiting
Boca Raton,Florida,33486,United States
Shawn Baca
Oregon Health Sciences University
Recruiting
Portland,Oregon,97239,United States
Atul Deodhar
Altoona Center for Clin Res
Recruiting
Duncansville,Pennsylvania,16635,United States
Alan J Kivitz
FL Medical Clinic Orlando Health
Recruiting
Zephyrhills,Florida,33542,United States
Natalie Faith
Rheumatology Pulmonary Clinic
Recruiting
Beckley,West Virginia,25801,United States
Wassim S Saikali
West Tennessee Research Institute
Recruiting
Jackson,Tennessee,38305,United States
Jacob A Aelion
Worldwide Contacts
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