Clinical trial NCT01892436: Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis
Official title: A Three-year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: Extension study, psoriatic arthritis, pre-filled syringe
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-07-04
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.


Eligibility criteria: Inclusion criteria

* Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed
* Subjects must have participated in core study CAIN457F2306, and must have completed the entire treatment period
* Subjects must be deemed by the investigator to benefit from continued secukinumab therapy

Exclusion criteria

* Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab
* Any subject who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms
* Pregnant or nursing (lactating) women
* Women of child-bearing potential, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., 20 weeks in EU)

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
timeFrame: weeks 116, 128, 140, 156, 180, 208, 232 and 260
measure: Proportion of Subjects Who Reached ACR50
timeFrame: weeks 116, 128, 140, 156, 180, 208, 232 and 260
measure: Proportion of Subjects Who Reached ACR70
timeFrame: weeks 116, 128, 140, 156, 180, 208, 232 and 260
Secondary outcomes:
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: weeks 116, 128, 140, 156, 180, 208, 232 and 260
measure: Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: weeks 116, 128, 140, 156, 180, 208, 232 and 260
measure: Change From Baseline in Disease Activity Score-CRP (DAS28)
timeFrame: weeks 116, 128, 140, 156, 180, 208, 232 and 260
measure: Percentage of Subjects Achieving Low Disease Activity
timeFrame: weeks 116, 128, 140, 156, 180, 208, 232 and 260
measure: Percentage of Subjects Achieving Disease Remission (DAS28<2.6)
timeFrame: weeks 116, 128, 140, 156, 180, 208, 232 and 260
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Mesa
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Paradise Valley
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Upland
country: United States
facility: Novartis Investigative Site
state: California
city: Tamarac
country: United States
facility: Novartis Investigative Site
state: Florida
city: Eagan
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Lincoln
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Freehold
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Duncansville
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Columbia
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Benbrook
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: League City
country: United States
facility: Novartis Investigative Site
state: Texas
city: Mesquite
country: United States
facility: Novartis Investigative Site
state: Texas
city: Seattle
country: United States
facility: Novartis Investigative Site
state: Washington
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Caba
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Córdoba
country: Argentina
facility: Novartis Investigative Site
city: Maroochydore
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Malvern East
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Genk
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sevlievo
country: Bulgaria
facility: Novartis Investigative Site
state: Gabrovo
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: St. John's
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: Newmarket
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Waterloo
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Trois-Rivieres
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Bruntal
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Uherske Hradiste
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Zlin
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Aachen
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Gommern
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hildesheim
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Nürnberg
country: Germany
facility: Novartis Investigative Site
city: Ratingen
country: Germany
facility: Novartis Investigative Site
city: Zerbst
country: Germany
facility: Novartis Investigative Site
city: Ashkelon
country: Israel
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Tel Aviv
country: Israel
facility: Novartis Investigative Site
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Prato
country: Italy
facility: Novartis Investigative Site
state: PO
city: Siena
country: Italy
facility: Novartis Investigative Site
state: SI
city: Verona
country: Italy
facility: Novartis Investigative Site
state: VR
city: Lipa City
country: Philippines
facility: Novartis Investigative Site
state: Batangas
city: Dasmarinas
country: Philippines
facility: Novartis Investigative Site
state: Cavite
city: Manila
country: Philippines
facility: Novartis Investigative Site
state: Metro Manila
city: Las Pinas
country: Philippines
facility: Novartis Investigative Site
city: Manila
country: Philippines
facility: Novartis Investigative Site
city: Manila
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Kemerovo
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Lucenec
country: Slovakia
facility: Novartis Investigative Site
city: Khon Kaen
country: Thailand
facility: Novartis Investigative Site
state: THA
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
city: Leytonstone
country: United Kingdom
facility: Novartis Investigative Site
state: London
city: Cannock
country: United Kingdom
facility: Novartis Investigative Site
state: Staffordshire
city: Bradford
country: United Kingdom
facility: Novartis Investigative Site
state: West Yorkshire
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Mease PJ, Kavanaugh A, Reimold A, Tahir H, Rech J, Hall S, Geusens P, Pellet P, Delicha EM, Mpofu S, Pricop L. Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial. RMD Open. 2018 Aug 13;4(2):e000723. doi: 10.1136/rmdopen-2018-000723. eCollection 2018.