Clinical trial NCT04638647: Secukinumab Open Label Roll-over Extension Protocol
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Autoimmunity, Inflammation
Keywords: Secukinumab, Post trial access
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-11-20
Enrollment: 715
Sex: ALL
Minimum age (years): 6
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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: 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).

Primary outcomes:
measure: To evaluate long term safety as assessed by occurrence of AEs/SAEs
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Providence Medical Foundation
state: California
city: La Mesa
country: United States
facility: Purushotham Akther and Roshan Kotha MD Inc
state: California
city: San Leandro
country: United States
facility: Precn Comprehensive Clnl Rsch Solns
state: California
city: Santa Monica
country: United States
facility: Orrin Troum MD and Medical Associates
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials INC
state: California
city: Van Nuys
country: United States
facility: Medvin Clinical Research
state: California
city: West Hills
country: United States
facility: Center for Rheumatology Research
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: Boca Raton
country: United States
facility: Rheumatology Associates of South Florida
state: Florida
city: Homestead
country: United States
facility: Homestead Assoc In Research Inc
state: Florida
city: Plantation
country: United States
facility: IRIS Research and Development
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Zephyrhills
country: United States
facility: FL Medical Clinic Orlando Health
state: Florida
city: Willowbrook
country: United States
facility: Willow Rheumatology Wellness
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Rea Group
state: Indiana
city: Hagerstown
country: United States
facility: Klein and Associates
state: Maryland
city: Grand Blanc
country: United States
facility: Ahmed Arif Medical Research Center
state: Michigan
city: Lincoln
country: United States
facility: Physician Research Collaboration
state: Nebraska
city: Voorhees
country: United States
facility: Athritis Rheumatology and Back Disease Associates PA
state: New Jersey
city: Potsdam
country: United States
facility: St Lawrence Health System
state: New York
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Duncansville
country: United States
facility: Altoona Center for Clin Res
state: Pennsylvania
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Austin
country: United States
facility: Austin Regional Clinic Rheumatology
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheum Rsrch LLC
state: Texas
city: San Antonio
country: United States
facility: Accurate Clinical Research Inc
state: Texas
city: Bellevue
country: United States
facility: Overlake Internal Med Associates
state: Washington
city: Beckley
country: United States
facility: Rheumatology Pulmonary Clinic
state: West Virginia
city: Salvador
country: Brazil
facility: Novartis Investigative Site
state: BA
city: Vitoria
country: Brazil
facility: Novartis Investigative Site
state: ES
city: Juiz de Fora
country: Brazil
facility: Novartis Investigative Site
state: MG
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
city: Sao Jose do Rio Preto
country: Brazil
facility: Novartis Investigative Site
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Plovdiv
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Stara Zagora
country: Bulgaria
facility: Novartis Investigative Site
city: Hefei
country: China
facility: Novartis Investigative Site
state: Anhui
city: Hefei
country: China
facility: Novartis Investigative Site
state: Anhui
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Chongqing
country: China
facility: Novartis Investigative Site
state: Chongqing
city: Xiamen
country: China
facility: Novartis Investigative Site
state: Fujian
city: Guang Zhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Shantou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Shenzhen
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Zhuzhou
country: China
facility: Novartis Investigative Site
state: Hunan
city: Baotou
country: China
facility: Novartis Investigative Site
state: Inner Mongolia
city: Hohhot
country: China
facility: Novartis Investigative Site
state: Inner Mongolia
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Yangzhou
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nanchang
country: China
facility: Novartis Investigative Site
state: Jiangxi
city: Pingxiang
country: China
facility: Novartis Investigative Site
state: Jiangxi
city: Chang Chun
country: China
facility: Novartis Investigative Site
state: Jilin
city: Linyi
country: China
facility: Novartis Investigative Site
state: Shandong
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Urumqi
country: China
facility: Novartis Investigative Site
state: Xinjiang
city: KunMing
country: China
facility: Novartis Investigative Site
state: Yun Nan
city: Wenzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Bengbu
country: China
facility: Novartis Investigative Site
city: Jinan
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Tianjin
country: China
facility: Novartis Investigative Site
city: Zhejiang
country: China
facility: Novartis Investigative Site
city: Chia
country: Colombia
facility: Novartis Investigative Site
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Novartis Investigative Site
state: Santander
city: Ibague
country: Colombia
facility: Novartis Investigative Site
state: Tolima
city: Bogota
country: Colombia
facility: Novartis Investigative Site
city: Ostrava
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Brno-Zidonice
country: Czechia
facility: Novartis Investigative Site
state: CZE
city: Hradec Kralove
country: Czechia
facility: Novartis Investigative Site
state: CZE
city: Prague
country: Czechia
facility: Novartis Investigative Site
state: Prague 1
city: Brno Bohunice
country: Czechia
facility: Novartis Investigative Site
city: Praha 11
country: Czechia
facility: Novartis Investigative Site
city: Praha 2
country: Czechia
facility: Novartis Investigative Site
city: Praha 4
country: Czechia
facility: Novartis Investigative Site
city: Praha 5
country: Czechia
facility: Novartis Investigative Site
city: Uherske Hradiste
country: Czechia
facility: Novartis Investigative Site
city: Patra
country: Greece
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Guatemala
country: Guatemala
facility: Novartis Investigative Site
city: Guatemala
country: Guatemala
facility: Novartis Investigative Site
city: Guatemala
country: Guatemala
facility: Novartis Investigative Site
city: Surat
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Mumbai
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nashik
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Hyderabad
country: India
facility: Novartis Investigative Site
state: Telangana
city: New Delhi
country: India
facility: Novartis Investigative Site
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Reggio Emilia
country: Italy
facility: Novartis Investigative Site
state: RE
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Kuching
country: Malaysia
facility: Novartis Investigative Site
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Metepec
country: Mexico
facility: Novartis Investigative Site
state: Estado De Mexico
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: Culiacan
country: Mexico
facility: Novartis Investigative Site
state: MEX
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
state: Dolnoslaskie
city: Krakow
country: Poland
facility: Novartis Investigative Site
state: Malopolskie
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Sochaczew
country: Poland
facility: Novartis Investigative Site
city: Torun
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Barnaul
country: Russian Federation
facility: Novartis Investigative Site
city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Kemerovo
country: Russian Federation
facility: Novartis Investigative Site
city: Kemerovo
country: Russian Federation
facility: Novartis Investigative Site
city: Krasnodar
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saratov
country: Russian Federation
facility: Novartis Investigative Site
city: Smolensk
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Ulyanovsk
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Panorama
country: South Africa
facility: Novartis Investigative Site
state: Western Cape
city: Stellenbosch
country: South Africa
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Santander
country: Spain
facility: Novartis Investigative Site
state: Cantabria
city: La Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Santiago De Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Bilbao
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Vigo
country: Spain
facility: Novartis Investigative Site
state: Pontevedra
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: St Gallen
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: