Clinical trial NCT01392326: Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: Psoriatic arthritis
PsA
ACR
CASPAR
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 606
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 assess the efficacy and safety of secukinumab in patients with active psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.


Eligibility criteria: Inclusion criteria:

* Male or non-pregnant, non-lactating female patients at least 18 years of age
* Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
* Rheumatoid factor and anti-CCP antibodies negative
* Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥2cm diameter or nail changes consistent with psoriasis or documented history o plaque psoriasis

Exclusion criteria:

* Chest X-ray with evidence of ongoing infectious or malignant process
* Subjects who have previously been treated with more than 3 different TNFα inhibitors
* Subjects taking high potency opioid analgesics
* Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo
timeFrame: Week 24
Secondary outcomes:
measure: Percent of Subjects Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline
timeFrame: Week 24
measure: Percent of Subjects Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline
timeFrame: Week 24
measure: Change From Baseline in DAS28-CRP for Secukinumab 75 or 150 mg
timeFrame: Week 24
measure: Change From Baseline in SF36-PCS for Secukinumab 75 or 150 mg
timeFrame: Week 24
measure: Change From Baseline in HAQ-DI for Secukinumab 75 or 150 mg
timeFrame: Week 24
measure: Percent of Patients Achieving ACR50 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo
timeFrame: Week 24
measure: Change From Baseline for Joint/Bone Structural Damage (Van Der Heijde Modified Total Sharp Score) for Secukinumab 75 and 150 mg (Pooled Doses)
timeFrame: Week 24
measure: Percent of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Baseline
timeFrame: Week 24
measure: Percent of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline
timeFrame: Week 24
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: Newnan
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Eagan
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Richmond Heights
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: Johnston
country: United States
facility: Novartis Investigative Site
state: Rhode Island
city: Columbia
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: North Charleston
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: Houston
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: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Maroochydore
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Malvern
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: RS
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Sevlievo
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
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
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: Czech Republic
facility: Novartis Investigative Site
city: Uherske Hradiste
country: Czech Republic
facility: Novartis Investigative Site
city: Zlin
country: Czech Republic
facility: Novartis Investigative Site
city: Aachen
country: Germany
facility: Novartis Investigative Site
city: Berlin
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: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Herne
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: Valeggio Sul Mincio
country: Italy
facility: Novartis Investigative Site
state: (vr)
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: 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: 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: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 1
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Cluj Napoca
country: Romania
facility: Novartis Investigative Site
city: Iasi
country: Romania
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: Piestany
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Lucenec
country: Slovakia
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
city: Khon Kaen
country: Thailand
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
state: England
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, Pricop L, Mpofu S; FUTURE 1 study group. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study. ACR Open Rheumatol. 2020 Jan;2(1):18-25. doi: 10.1002/acr2.11097. Epub 2019 Nov 14.
citation: Deodhar A, Gladman DD, McInnes IB, Spindeldreher S, Martin R, Pricop L, Porter B, Safi J Jr, Shete A, Bruin G. Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis. J Rheumatol. 2020 Apr;47(4):539-547. doi: 10.3899/jrheum.190116. Epub 2019 Jun 15.
citation: Kavanaugh A, Mease PJ, Reimold AM, Tahir H, Rech J, Hall S, Geusens P, Wang Z, Pricop L, Mpofu S; FUTURE-1 Study Group. Secukinumab for Long-Term Treatment of Psoriatic Arthritis: A Two-Year Followup From a Phase III, Randomized, Double-Blind Placebo-Controlled Study. Arthritis Care Res (Hoboken). 2017 Mar;69(3):347-355. doi: 10.1002/acr.23111.
citation: Strand V, Mease P, Gossec L, Elkayam O, van den Bosch F, Zuazo J, Pricop L, Mpofu S; FUTURE 1 study group. Secukinumab improves patient-reported outcomes in subjects with active psoriatic arthritis: results from a randomised phase III trial (FUTURE 1). Ann Rheum Dis. 2017 Jan;76(1):203-207. doi: 10.1136/annrheumdis-2015-209055. Epub 2016 May 11.
citation: Mease PJ, McInnes IB, Kirkham B, Kavanaugh A, Rahman P, van der Heijde D, Landewe R, Nash P, Pricop L, Yuan J, Richards HB, Mpofu S; FUTURE 1 Study Group. Secukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis. N Engl J Med. 2015 Oct;373(14):1329-39. doi: 10.1056/NEJMoa1412679.