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NCT04638647PHASE4Recruiting

Secukinumab Open Label Roll-over Extension Protocol

Novartis Pharmaceuticals

Start Date

12/22/2020

Completion Date

4/4/2030

Summary

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.

Eligibility Criteria

Age Range: 6 years to 100 years

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).

Interventions

BIOLOGICAL

Secukinumab s.c. injection

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Conditions

Autoimmunity, Inflammation

Locations

Providence Medical Foundation

Fullerton, California 92835

United States

Purushotham Akther and Roshan Kotha MD Inc

La Mesa, California 91942

United States

Precn Comprehensive Clnl Rsch Solns

San Leandro, California 94578

United States

Orrin Troum MD and Medical Associates

Santa Monica, California 90404

United States

Inland Rheumatology Clinical Trials INC

Upland, California 91786

United States

Medvin Clinical Research

Van Nuys, California 91405

United States

Center for Rheumatology Research

West Hills, California 91307

United States

Denver Arthritis Clinic

Denver, Colorado 80230

United States

Rheumatology Associates of South Florida

Boca Raton, Florida 33486

United States

Homestead Assoc In Research Inc

Homestead, Florida 33033

United States

IRIS Research and Development

Plantation, Florida 33324

United States

Conquest Research

Winter Park, Florida 32789

United States

FL Medical Clinic Orlando Health

Zephyrhills, Florida 33542

United States

Willow Rheumatology Wellness

Willowbrook, Illinois 60527

United States

Dawes Fretzin Clinical Rea Group

Indianapolis, Indiana 46256

United States

Klein and Associates

Hagerstown, Maryland 21740

United States

Ahmed Arif Medical Research Center

Grand Blanc, Michigan 48439

United States

Physician Research Collaboration

Lincoln, Nebraska 68516

United States

Arthritis Rheumatology and Bone Disease Associates PA

Voorhees Township, New Jersey 08043

United States

St Lawrence Health System

Potsdam, New York 13676

United States

Oregon Health Sciences University

Portland, Oregon 97239

United States

Altoona Center for Clin Res

Duncansville, Pennsylvania 16635

United States

West Tennessee Research Institute

Jackson, Tennessee 38305

United States

Austin Regional Clinic Rheumatology

Austin, Texas 78731

United States

Accurate Clinical Research Inc

Houston, Texas 77089

United States

Southwest Rheum Rsrch LLC

Mesquite, Texas 75150

United States

Overlake Arthritis and Osteoporosis

Bellevue, Washington 98004

United States

Rheumatology Pulmonary Clinic

Beckley, West Virginia 25801

United States

Novartis Investigative Site

Vitória, Espírito Santo 29055 450

Brazil

Novartis Investigative Site

Salvador, Estado de Bahia 40150 150

Brazil

Novartis Investigative Site

Juiz de Fora, Minas Gerais 36010 570

Brazil

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São Paulo, São Paulo 01244-030

Brazil

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São Paulo, São Paulo 04266 010

Brazil

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Rio de Janeiro, 20241-180

Brazil

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Sao Jose Rio Preto, 15090 000

Brazil

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Pleven, 5800

Bulgaria

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Plovdiv, 4002

Bulgaria

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Sofia, 1407

Bulgaria

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Sofia, 1431

Bulgaria

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Sofia, 1784

Bulgaria

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Stara Zagora, 6000

Bulgaria

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Hefei, Anhui 230001

China

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Hefei, Anhui 230601

China

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Beijing, Beijing Municipality 100044

China

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Chongqing, Chongqing Municipality 400010

China

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Xiamen, Fujian 361001

China

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Guangzhou, Guangdong 510080

China

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Guangzhou, Guangdong 510120

China

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Guangzhou, Guangdong 510515

China

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Shantou, Guangdong 515000

China

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Shenzhen, Guangdong 518020

China

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Wuhan, Hubei 430030

China

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Changsha, Hunan 410011

China

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Zhuzhou, Hunan 412000

China

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Baotou, Inner Mongolia 014010

China

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Hohhot, Inner Mongolia 010050

China

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Nanjing, Jiangsu 210008

China

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Nanjing, Jiangsu 210009

China

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Yangzhou, Jiangsu 225001

China

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Nanchang, Jiangxi 330006

China

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Pingxiang, Jiangxi 337000

China

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Changchun, Jilin 130021

China

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Linyi, Shandong 276000

China

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Chengdu, Sichuan 610041

China

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Ürümqi, Xinjiang 830001

China

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Kunming, Yunnan 650000

China

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Ningbo, Zhejiang 315016

China

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Wenzhou, Zhejiang 325000

China

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Beijing, 100000

China

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Beijing, 100050

China

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Beijing, 100730

China

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Bengbu, 233004

China

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Jinan, 250012

China

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Shanghai, 200040

China

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Shanghai, 200050

China

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Shanghai, 200127

China

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Tianjin, 300052

China

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Bogota, Cundinamarca 110221

Colombia

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Chía, Cundinamarca 250001

Colombia

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Bucaramanga, Santander Department 680003

Colombia

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Ibague, Tolima Department 730006

Colombia

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Ostrava, Czech Republic 772 00

Czechia

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Brno-Zidonice, CZE 61500

Czechia

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Prague, Prague 1 11000

Czechia

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Brno, 625 00

Czechia

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Brno, 638 00

Czechia

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Hradec Králové, 500 05

Czechia

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Prague, 128 00

Czechia

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Prague, 140 59

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Prague, 148 00

Czechia

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Prague, 150 06

Czechia

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Uherské Hradiště, 686 01

Czechia

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Pátrai, 26443

Greece

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Guatemala City, 01001

Guatemala

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Guatemala City, 01009

Guatemala

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Guatemala City, 01010

Guatemala

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Guatemala City, 01011

Guatemala

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Surat, Gujarat 395009

India

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Bangalore, Karnataka 560 079

India

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Mumbai, Maharashtra 400 053

India

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Nashik, Maharashtra 422101

India

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Hyderabad, Telangana 500082

India

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New Delhi, 110029

India

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Florence, FI 50134

Italy

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Reggio Emilia, RE 42123

Italy

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Kuching, Sarawak 93586

Malaysia

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Kuala Lumpur, 59100

Malaysia

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Guadalajara, Jalisco 44160

Mexico

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Culiacan, State of Mexico 80000

Mexico

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Metepec, State of Mexico 52140

Mexico

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Krakow, Lesser Poland Voivodeship 30-727

Poland

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Wroclaw, Lower Silesian Voivodeship 52-210

Poland

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Bialystok, 15-351

Poland

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Bydgoszcz, 85-168

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Krakow, 30-002

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Poznan, 60-218

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Sochaczew, 96-500

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Torun, 87-100

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Warsaw, 02-118

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Warsaw, 02-637

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Warsaw, 02-962

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Warsaw, 04-305

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Wroclaw, 53-224

Poland

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Lisbon, 1649-035

Portugal

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Barnaul, 656024

Russia

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Chelyabinsk, 454048

Russia

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Kazan', 420012

Russia

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Kazan', 420064

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Kemerovo, 650029

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Kemerovo, 650070

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Krasnodar, 350020

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Moscow, 115522

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Moscow, 119296

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Moscow, 127473

Russia

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Saint Petersburg, 190068

Russia

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Saint Petersburg, 197022

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Saint Petersburg, 197198

Russia

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Saint Petersburg, 197198

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Saint Petersburg, 197341

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Saratov, 410053

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Smolensk, 214019

Russia

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Ulyanovsk, 432063

Russia

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Yaroslavl, 150003

Russia

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Yaroslavl, 150054

Russia

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Yekaterinburg, 620023

Russia

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Yekaterinburg, 620028

Russia

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Panorama, Western Cape 7500

South Africa

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Stellenbosch, Western Cape 7600

South Africa

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Seoul, 03080

South Korea

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Seoul, 06351

South Korea

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Santiago Compostela, A Coruna 15706

Spain

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Málaga, Andalusia 29009

Spain

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L'Hospitalet de Llobregat, Barcelona 08907

Spain

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Bilbao, Bizkaia 48013

Spain

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Santander, Cantabria 39008

Spain

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Vigo, Pontevedra 36214

Spain

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A Coruña, 15006

Spain

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Madrid, 28009

Spain

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Madrid, 28009

Spain

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Madrid, 28041

Spain

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Madrid, 28046

Spain

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Madrid, 28046

Spain

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Seville, 41009

Spain

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Valencia, 46026

Spain

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Basel, 4031

Switzerland

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Bern, 3010

Switzerland

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Sankt Gallen, 9007

Switzerland