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).
Study Location
Novartis Investigative Site
Recruiting
Rio de Janeiro,20241-180,Brazil
Novartis Investigative Site
Recruiting
Salvador,BA,40150 150,Brazil
Novartis Investigative Site
Recruiting
Sao Jose do Rio Preto,15090 000,Brazil
Novartis Investigative Site
Recruiting
Juiz de Fora,MG,36010 570,Brazil
Novartis Investigative Site
Recruiting
Vitoria,ES,29055 450,Brazil
Novartis Investigative Site
Recruiting
São Paulo,SP,01244-030,Brazil
Novartis Investigative Site
Recruiting
Sao Paulo,SP,04266 010,Brazil
Novartis Investigative Site
Recruiting
Plovdiv,4002,Bulgaria
Novartis Investigative Site
Recruiting
Sofia,1431,Bulgaria
Novartis Investigative Site
Recruiting
Sofia,1784,Bulgaria
Novartis Investigative Site
Recruiting
Shantou,Guangdong,515041,China
Novartis Investigative Site
Recruiting
Baotou,Inner Mongolia,014010,China
Novartis Investigative Site
Recruiting
Hefei,Anhui,230001,China
Novartis Investigative Site
Recruiting
Shenzhen,Guangdong,518020,China
Novartis Investigative Site
Recruiting
Beijing,Beijing,100044,China
Novartis Investigative Site
Recruiting
Hefei,Anhui,230601,China
Novartis Investigative Site
Recruiting
Changsha,Hunan,410011,China
Novartis Investigative Site
Recruiting
Hohhot,Inner Mongolia,10050,China
Novartis Investigative Site
Recruiting
Chongqing,Chongqing,400010,China
Novartis Investigative Site
Recruiting
Guang Zhou,Guang Dong Province,510120,China
Novartis Investigative Site
Recruiting
Nanjing,Jiangsu,210008,China
Novartis Investigative Site
Recruiting
Wuhan,Hubei,430030,China
Novartis Investigative Site
Recruiting
Guangzhou,Guangdong,510080,China
Novartis Investigative Site
Recruiting
Nanjing,Jiangsu,210009,China
Novartis Investigative Site
Recruiting
Xiamen,Fujian,361001,China
Novartis Investigative Site
Recruiting
Guangzhou,Guangdong,510515,China
Conquest Research
Recruiting
Winter Park,Florida,32789,United States
Anand Patel
Purushotham Akther and Roshan Kotha MD Inc
Recruiting
La Mesa,California,91942,United States
Roshan Kotha
Ahmed Arif Medical Research Center
Recruiting
Grand Blanc,Michigan,48439,United States
Ali Karrar
Oregon Health Sciences University
Recruiting
Portland,Oregon,97239,United States
Atul Deodhar
Homestead Associates in Research Inc
Recruiting
Miami,Florida,33032,United States
Gilberto Seco
Integral Rheumatology and Immunology Specialists IRIS
Recruiting
Plantation,Florida,33324,United States
Guillermo Valenzuela
Dawes Fretzin Clinical Rea Group .
Recruiting
Indianapolis,Indiana,46256,United States
Scott Fretzin
Rheumatology Pulmonary Clinic
Recruiting
Beckley,West Virginia,25801,United States
Wassim S Saikali
Athritis Rheumatology and Back Disease Associates PA .
Recruiting
Voorhees,New Jersey,08043,United States
Joshua B Sundhar
Precn Comprehensive Clnl Rsch Solns
Recruiting
San Leandro,California,94578,United States
Suneet Grewal
Klein and Associates Rheumatology
Recruiting
Cumberland,Maryland,21740,United States
Ladonna Ortt
Steven J Klein
Denver Arthritis Clinic .
Recruiting
Denver,Colorado,80230,United States
Christopher Ryan Antolini
Southwest Rheum Rsrch LLC
Recruiting
Mesquite,Texas,75150,United States
Atul K K. Singhal
Center for Rheumatology Research Rheumatology
Recruiting
West Hills,California,91307,United States
Lauren Jackson
Nazanin Firooz
West Tennessee Research Institute
Recruiting
Jackson,Tennessee,38305,United States
Jacob A. Aelion
Providence Medical Foundation .
Recruiting
Fullerton,California,92835,United States
Lilia Ignacios
Shirley Pang
Medvin Clinical Research .
Recruiting
Van Nuys,California,91405,United States
Samy Metyas
Worldwide Contacts
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