Clinical trial NCT01770379: Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.
Official title: A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, RA, IL-17 blocker, subcutaneous, self-injection, AIN457, AIN457F, secukinumab, anti-TNFα, pre-filled syringe
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-01-17
Enrollment: 242
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 will provide efficacy and safety data of the secukinumab pre-filled syringe (PFS) for subcutaneous self-administration in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents.


Eligibility criteria: Inclusion Criteria: • Presence of Rheumatoid Arthritis classified by ACR 2010 revised criteria for at least 3 months •Disease activity defined by ≥6 tender joints out of 68 and ≥ 6 swollen joints out of 66 at baseline and with: Either Anti-CCP antibodies positive OR Rheumatoid Factor positive AND WITH Either hsCRP ≥ 10 mg/L OR ESR ≥28 mm/1st hr •Intake of at least one anti-TNF-α agent such as etanercept, adalimumab, infliximab, certolizumab or golimumab for at least 3 months before entering the study and to have experienced an inadequate response to treatment or to have been intolerant to at least one administration Exclusion Criteria:

* Current RA functional status class IV according to the ACR 1991 revised criteria •Previous use of secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor and/or any history of hypersensitivity to secukinumab or its excipient or to drugs of similar chemical classes. Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).
timeFrame: Week 24
Secondary outcomes:
measure: Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP)
timeFrame: Week 24
measure: Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Week 24
measure: Percentage of Participants Achieving ACR50
timeFrame: Week 24
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Santa Monica
country: United States
facility: Novartis Investigative Site
state: California
city: Upland
country: United States
facility: Novartis Investigative Site
state: California
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Pembroke Pines
country: United States
facility: Novartis Investigative Site
state: Florida
city: Zephyrhills
country: United States
facility: Novartis Investigative Site
state: Florida
city: Cumberland
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Edina
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Tupelo
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Lees Summit
country: United States
facility: Novartis Investigative Site
state: Missouri
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Reno
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Albuquerque
country: United States
facility: Novartis Investigative Site
state: New Mexico
city: Zanesville
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: North Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Rapid City
country: United States
facility: Novartis Investigative Site
state: South Dakota
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Amarillo
country: United States
facility: Novartis Investigative Site
state: Texas
city: Benbrook
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Mesquite
country: United States
facility: Novartis Investigative Site
state: Texas
city: Mar del Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Novartis Investigative Site
state: Tucuman
city: Salvador
country: Brazil
facility: Novartis Investigative Site
state: BA
city: Juiz de Fora
country: Brazil
facility: Novartis Investigative Site
state: MG
city: Curitiba
country: Brazil
facility: Novartis Investigative Site
state: PR
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Bogotá
country: Colombia
facility: Novartis Investigative Site
city: Cali
country: Colombia
facility: Novartis Investigative Site
city: Praha 2
country: Czech Republic
facility: Novartis Investigative Site
city: Uherske Hradiste
country: Czech Republic
facility: Novartis Investigative Site
city: Santo Domingo
country: Dominican Republic
facility: Novartis Investigative Site
state: Republica Dominicana
city: Bad Doberan
country: Germany
facility: Novartis Investigative Site
city: Göttingen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Pirna
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
state: GR
city: Heraklion
country: Greece
facility: Novartis Investigative Site
state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Secunderabad
country: India
facility: Novartis Investigative Site
state: Andhra Pradesh
city: New Delhi
country: India
facility: Novartis Investigative Site
state: Delhi
city: Pune
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Pune
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Jaipur
country: India
facility: Novartis Investigative Site
state: Rajasthan
city: Bergamo
country: Italy
facility: Novartis Investigative Site
state: BG
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Verona
country: Italy
facility: Novartis Investigative Site
state: VR
city: Bologna
country: Italy
facility: Novartis Investigative Site
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Takasaki-city
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Hiroshima-city
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kumamoto-city
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Miyagi-gun
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Nagano-city
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Sasebo-city
country: Japan
facility: Novartis Investigative Site
state: Nagasaki
city: Setouchi-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Kawachinagano-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Tokorozawa-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Hamamatsu-city
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Toyama-city
country: Japan
facility: Novartis Investigative Site
state: Toyama
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Panama City
country: Panama
facility: Novartis Investigative Site
state: Panamá
city: Panama City
country: Panama
facility: Novartis Investigative Site
state: Panamá
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Panorama
country: South Africa
facility: Novartis Investigative Site
state: Western Cape
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Huang Y, Fan Y, Liu Y, Xie W, Zhang Z. Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials. Clin Rheumatol. 2019 Oct;38(10):2765-2776. doi: 10.1007/s10067-019-04595-1. Epub 2019 May 14.