Last Update: Nov 15, 2024
An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Secukinumab Study and Are Judged by the Investigator to Benefit From Continued Secukinumab Treatment
ClinicalTrials.gov Identifier:
Novartis Reference Number:CAIN457A02001B
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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.

Autoimmunity, Inflammation
Phase4
Recruiting
715
Dec 22, 2020
Feb 29, 2028
All
6 Years - (Child, Adult, Older Adult)

Interventions

Biological

Secukinumab s.c. injection

Secukinumab pre-filled syringes (PFS) for 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

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

Recruiting

Mesquite,Texas,75150,United States

Atul K Singhal
Nancy De La Cruz

Center for Rheumatology Research

Recruiting

West Hills,California,91307,United States

Nazanin Firooz
Lauren Jackson

Ahmed Arif Medical Research Center

Recruiting

Grand Blanc,Michigan,48439,United States

Ali Karrar

Homestead Assoc In Research Inc

Recruiting

Homestead,Florida,33033,United States

Gilberto Seco
Jhenny Grullon

Altoona Center for Clin Res

Recruiting

Duncansville,Pennsylvania,16635,United States

Alan J Kivitz
Mary Beyer

Denver Arthritis Clinic

Recruiting

Denver,Colorado,80230,United States

Christopher Ryan Antolini

Rheumatology Pulmonary Clinic

Recruiting

Beckley,West Virginia,25801,United States

Catie Webb
Wassim S Saikali

Oregon Health Sciences University

Recruiting

Portland,Oregon,97239,United States

Atul Deodhar
Yuki Harry

Integral Rheumatology and Immunology Specialists IRIS

Recruiting

Plantation,Florida,33324,United States

Guillermo Valenzuela

Accurate Clinical Research Inc

Recruiting

San Antonio,Texas,78229,United States

Philip Waller
Viet Ta

FL Medical Clinic Orlando Health

Recruiting

Zephyrhills,Florida,33542,United States

Endora Ankrah
Natalie Faith

Purushotham Akther and Roshan Kotha MD Inc

Recruiting

La Mesa,California,91942,United States

Eva Duran
Roshan Kotha

West Tennessee Research Institute

Recruiting

Jackson,Tennessee,38305,United States

Jacob A. Aelion
Kim Smith

Medvin Clinical Research

Recruiting

Van Nuys,California,91405,United States

Samy Metyas

Illinois Bone And Joint Institute

Recruiting

Hinsdale,Illinois,60521,United States

Angela R Crowley
Swarnika Sampat

Precn Comprehensive Clnl Rsch Solns

Recruiting

San Leandro,California,94578,United States

Suneet Grewal

Dawes Fretzin Clinical Rea Group

Recruiting

Indianapolis,Indiana,46256,United States

Joan Prusa
Scott Fretzin

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