Autoimmunity, Inflammation Clinical Trial
Official title:
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
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.
| Status | Recruiting |
| Enrollment | 715 |
| Est. completion date | October 18, 2027 |
| Est. primary completion date | October 30, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years and older |
| Eligibility | 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). |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Novartis Investigative Site | Juiz de Fora | MG |
| Brazil | Novartis Investigative Site | Rio de Janeiro | |
| Brazil | Novartis Investigative Site | Salvador | BA |
| Brazil | Novartis Investigative Site | Sao Jose do Rio Preto | |
| Brazil | Novartis Investigative Site | Sao Paulo | SP |
| Brazil | Novartis Investigative Site | São Paulo | SP |
| Brazil | Novartis Investigative Site | Vitoria | ES |
| Bulgaria | Novartis Investigative Site | Plovdiv | |
| Bulgaria | Novartis Investigative Site | Sofia | |
| Bulgaria | Novartis Investigative Site | Sofia | |
| China | Novartis Investigative Site | Baotou | Inner Mongolia |
| China | Novartis Investigative Site | Beijing | |
| China | Novartis Investigative Site | Beijing | |
| China | Novartis Investigative Site | Beijing | Beijing |
| China | Novartis Investigative Site | Bengbu | |
| China | Novartis Investigative Site | Chang Chun | Jilin |
| China | Novartis Investigative Site | Changsha | Hunan |
| China | Novartis Investigative Site | Chengdu | Sichuan |
| China | Novartis Investigative Site | Chongqing | Chongqing |
| China | Novartis Investigative Site | Guang Zhou | Guang Dong Province |
| China | Novartis Investigative Site | Guangzhou | Guangdong |
| China | Novartis Investigative Site | Guangzhou | Guangdong |
| China | Novartis Investigative Site | Hefei | Anhui |
| China | Novartis Investigative Site | Hefei | Anhui |
| China | Novartis Investigative Site | Hohhot | Inner Mongolia |
| China | Novartis Investigative Site | Jinan | |
| China | Novartis Investigative Site | KunMing | Yun Nan |
| China | Novartis Investigative Site | Linyi | Shandong |
| China | Novartis Investigative Site | Nanchang | Jiangxi |
| China | Novartis Investigative Site | Nanjing | Jiangsu |
| China | Novartis Investigative Site | Nanjing | Jiangsu |
| China | Novartis Investigative Site | Pingxiang | Jiangxi |
| China | Novartis Investigative Site | Shanghai | |
| China | Novartis Investigative Site | Shanghai | |
| China | Novartis Investigative Site | Shanghai | |
| China | Novartis Investigative Site | Shantou | Guangdong |
| China | Novartis Investigative Site | Shenzhen | Guangdong |
| China | Novartis Investigative Site | Tianjin | |
| China | Novartis Investigative Site | Urumqi | Xinjiang |
| China | Novartis Investigative Site | Wenzhou | Zhejiang |
| China | Novartis Investigative Site | Wuhan | Hubei |
| China | Novartis Investigative Site | Xiamen | Fujian |
| China | Novartis Investigative Site | Yangzhou | Jiangsu |
| China | Novartis Investigative Site | Zhejiang | |
| China | Novartis Investigative Site | Zhuzhou | Hunan |
| Colombia | Novartis Investigative Site | Bogota | |
| Colombia | Novartis Investigative Site | Bucaramanga | Santander |
| Colombia | Novartis Investigative Site | Cundinamarca | |
| Colombia | Novartis Investigative Site | Ibague | Tolima |
| Czechia | Novartis Investigative Site | Brno Bohunice | |
| Czechia | Novartis Investigative Site | Brno-Zidonice | CZE |
| Czechia | Novartis Investigative Site | Hradec Kralove | CZE |
| Czechia | Novartis Investigative Site | Ostrava | Czech Republic |
| Czechia | Novartis Investigative Site | Prague | Prague 1 |
| Czechia | Novartis Investigative Site | Prague 4 | |
| Czechia | Novartis Investigative Site | Praha 11 | |
| Czechia | Novartis Investigative Site | Praha 2 | |
| Czechia | Novartis Investigative Site | Praha 5 | |
| Czechia | Novartis Investigative Site | Uherske Hradiste | |
| Greece | Novartis Investigative Site | Patra | |
| Guatemala | Novartis Investigative Site | Guatemala | |
| Guatemala | Novartis Investigative Site | Guatemala | |
| Guatemala | Novartis Investigative Site | Guatemala | |
| Guatemala | Novartis Investigative Site | Guatemala City | |
| Guatemala | Novartis Investigative Site | Guatemala City | |
| India | Novartis Investigative Site | Bangalore | Karnataka |
| India | Novartis Investigative Site | Hyderabad | Telangana |
| India | Novartis Investigative Site | Mumbai | Maharashtra |
| India | Novartis Investigative Site | Nashik | Maharashtra |
| India | Novartis Investigative Site | New Delhi | |
| India | Novartis Investigative Site | Surat | Gujarat |
| Korea, Republic of | Novartis Investigative Site | Seoul | |
| Korea, Republic of | Novartis Investigative Site | Seoul | |
| Malaysia | Novartis Investigative Site | Kuala Lumpur | |
| Malaysia | Novartis Investigative Site | Kuching | Sarawak |
| Mexico | Novartis Investigative Site | Culiacan | MEX |
| Mexico | Novartis Investigative Site | Guadalajara | Jalisco |
| Mexico | Novartis Investigative Site | Metepec | Estado De Mexico |
| Poland | Novartis Investigative Site | Bialystok | |
| Poland | Novartis Investigative Site | Krakow | |
| Poland | Novartis Investigative Site | Krakow | Malopolskie |
| Poland | Novartis Investigative Site | Poznan | |
| Poland | Novartis Investigative Site | Sochaczew | |
| Poland | Novartis Investigative Site | Torun | |
| Poland | Novartis Investigative Site | Warszawa | |
| Poland | Novartis Investigative Site | Warszawa | |
| Poland | Novartis Investigative Site | Warszawa | |
| Poland | Novartis Investigative Site | Warszawa | |
| Poland | Novartis Investigative Site | Wroclaw | |
| Poland | Novartis Investigative Site | Wroclaw | Dolnoslaskie |
| Russian Federation | Novartis Investigative Site | Barnaul | |
| Russian Federation | Novartis Investigative Site | Ekaterinburg | |
| Russian Federation | Novartis Investigative Site | Ekaterinburg | |
| Russian Federation | Novartis Investigative Site | Kazan | |
| Russian Federation | Novartis Investigative Site | Kazan | |
| Russian Federation | Novartis Investigative Site | Kemerovo | |
| Russian Federation | Novartis Investigative Site | Kemerovo | |
| Russian Federation | Novartis Investigative Site | Krasnodar | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Saint Petersburg | |
| Russian Federation | Novartis Investigative Site | Saint Petersburg | |
| Russian Federation | Novartis Investigative Site | Saint Petersburg | |
| Russian Federation | Novartis Investigative Site | Saratov | |
| Russian Federation | Novartis Investigative Site | Smolensk | |
| Russian Federation | Novartis Investigative Site | St Petersburg | |
| Russian Federation | Novartis Investigative Site | Ulyanovsk | |
| Russian Federation | Novartis Investigative Site | Yaroslavl | |
| South Africa | Novartis Investigative Site | Panorama | Western Cape |
| South Africa | Novartis Investigative Site | Stellenbosch | |
| Spain | Novartis Investigative Site | Bilbao | Pais Vasco |
| Spain | Novartis Investigative Site | Hospitalet de Llobregat | Barcelona |
| Spain | Novartis Investigative Site | La Coruna | Galicia |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Malaga | |
| Spain | Novartis Investigative Site | Santander | Cantabria |
| Spain | Novartis Investigative Site | Santiago De Compostela | Galicia |
| Spain | Novartis Investigative Site | Sevilla | Andalucia |
| Spain | Novartis Investigative Site | Valencia | |
| Spain | Novartis Investigative Site | Valencia | |
| Spain | Novartis Investigative Site | Vigo | Pontevedra |
| United States | Novartis Investigative Site | Austin | Texas |
| United States | Klein and Associates Rheumatology | Cumberland | Maryland |
| United States | Denver Arthritis Clinic . | Denver | Colorado |
| United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
| United States | Providence Medical Foundation . | Fullerton | California |
| United States | Ahmed Arif Medical Research Center | Grand Blanc | Michigan |
| United States | Dawes Fretzin Clinical Rea Group . | Indianapolis | Indiana |
| United States | West Tennessee Research Institute | Jackson | Tennessee |
| United States | Purushotham Akther and Roshan Kotha MD Inc | La Mesa | California |
| United States | Physician Research Collaboration . | Lincoln | Nebraska |
| United States | Southwest Rheum Rsrch LLC | Mesquite | Texas |
| United States | Homestead Associates in Research Inc | Miami | Florida |
| United States | Integral Rheumatology and Immunology Specialists IRIS | Plantation | Florida |
| United States | Oregon Health Sciences University | Portland | Oregon |
| United States | St Lawrence Health System Medical Campus | Potsdam | New York |
| United States | Precn Comprehensive Clnl Rsch Solns | San Leandro | California |
| United States | Orrin Troum MD and Medical Associates | Santa Monica | California |
| United States | Inland Rheumatology Clinical Trials INC | Upland | California |
| United States | Medvin Clinical Research . | Van Nuys | California |
| United States | Athritis, Rheumatology and Back Disease Associates, PA . | Voorhees | New Jersey |
| United States | Center for Rheumatology Research Rheumatology | West Hills | California |
| United States | Conquest Research | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Brazil, Bulgaria, China, Colombia, Czechia, Greece, Guatemala, India, Korea, Republic of, Malaysia, Mexico, Poland, Russian Federation, South Africa, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate long term safety as assessed by occurrence of AEs/SAEs | Serious adverse events (SAEs), adverse events (AEs), and injection site reactions | up to 2 years |