Clinical trial NCT02745080: Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis
Official title: A Randomized, Double-blind, Active Control, Multicenter Study to Evaluate the Efficacy at Week 52 of Secukinumab Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
secukinumab
adalimumab
monoclonal antibody
CASPAR
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-04-20
Enrollment: 853
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 was a randomized, double-blind, active controlled, multicenter, parallel-group study evaluating secukinumab monotherapy and adalimumab monotherapy in approximately 850 patients with active psoriatic arthritis (PsA) who are naïve to biologic therapy and are intolerant or having inadequate response to conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs).

Detailed description: The total maximum study duration, including the screening period was up to 76 weeks.

At Baseline, patients whose eligibility was confirmed were randomized to 1 of 2 groups (1:1): Group 1 (secukinumab 300 mg) or Group 2 (adalimumab 40 mg).

In order to maintain the blind, both groups received 1 or 2 placebo s.c. injections to keep consistency in the number of injections at each dosing visit. Secukinumab (300 mg) was available in 2 x 1.0 mL pre-filled syringes (PFS) and adalimumab was available in 1 x 0.4 mL PFS. Placebo (1.0 and 0.5 mL PFS) was also available.

Secukinumab 300 mg s.c injection (2 x 1 mL PFS) was administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks to Week 48.

Adalimumab 40 mg (1 x 0.4 mL PFS) was administered at Baseline followed by dosing every 2 weeks until Week 50.

Eligibility criteria: Key Inclusion Criteria:

* Diagnosis of PsA classified by CASPAR
* 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 of plaque psoriasis
* Inadequate control of symptoms with NSAIDs
* Inadequate control of symptoms with a conventional DMARD.

Key Exclusion Criteria:

* Pregnant or nursing women
* Evidence of ongoing infectious or malignant process
* Previous exposure to any biologic drug for Psoriatic Arthritis or Psoriasis
* Subjects taking high potency opioid analgesics
* Ongoing use of prohibited psoriasis treatments/medications
* Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 investigational agents.

Primary outcomes:
measure: Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 52
timeFrame: Week 52
measure: Percentage of Participants Who Achieved an American College of Rheumatology 50% (ACR50) Response at Week 52
timeFrame: Week 52
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) at Week 52
timeFrame: Baseline, Week 52
measure: Percentage of Participants Who Achieved Resolution of Enthesitis at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Novartis Investigative Site
state: California
city: Fullerton
country: United States
facility: Novartis Investigative Site
state: California
city: La Mesa
country: United States
facility: Novartis Investigative Site
state: California
city: Upland
country: United States
facility: Novartis Investigative Site
state: California
city: Bowling Green
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Lincoln
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Rochester
country: United States
facility: Novartis Investigative Site
state: New York
city: Bethlehem
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Duncansville
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Arlington
country: United States
facility: Novartis Investigative Site
state: Texas
city: Austin
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Mesquite
country: United States
facility: Novartis Investigative Site
state: Texas
city: Burlington
country: United States
facility: Novartis Investigative Site
state: Vermont
city: Seattle
country: United States
facility: Novartis Investigative Site
state: Washington
city: Spokane
country: United States
facility: Novartis Investigative Site
state: Washington
city: Glendale
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Kogarah
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Maroochydore
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Hobart
country: Australia
facility: Novartis Investigative Site
state: Tasmania
city: Malvern East
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Plovdiv
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: Victoria
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Novartis Investigative Site
state: Manitoba
city: Trois-Rivieres
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Bruntal
country: Czechia
facility: Novartis Investigative Site
city: Praha 2
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: Zlin
country: Czechia
facility: Novartis Investigative Site
city: Frederiksberg
country: Denmark
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Hyvinkaa
country: Finland
facility: Novartis Investigative Site
city: Kuopio
country: Finland
facility: Novartis Investigative Site
city: Brive-la-Gaillarde
country: France
facility: Novartis Investigative Site
city: Cahors
country: France
facility: Novartis Investigative Site
city: Chambray les Tours
country: France
facility: Novartis Investigative Site
city: Le Mans
country: France
facility: Novartis Investigative Site
city: Orleans
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Poitiers
country: France
facility: Novartis Investigative Site
city: Bad Doberan
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Herne
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Osnabruck
country: Germany
facility: Novartis Investigative Site
city: Schwerin
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Gyor
country: Hungary
facility: Novartis Investigative Site
city: Kistarcsa
country: Hungary
facility: Novartis Investigative Site
city: Veszprem
country: Hungary
facility: Novartis Investigative Site
city: Reykjavik
country: Iceland
facility: Novartis Investigative Site
city: Mumbai
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nashik
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Secunderabad
country: India
facility: Novartis Investigative Site
state: Telangana
city: New Delhi
country: India
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Kfar Saba
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
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: Arenzano
country: Italy
facility: Novartis Investigative Site
state: GE
city: Rozzano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Verona
country: Italy
facility: Novartis Investigative Site
state: VR
city: Bologna
country: Italy
facility: Novartis Investigative Site
city: Pisa
country: Italy
facility: Novartis Investigative Site
city: Torino
country: Italy
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Seocho Gu
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Valmiera
country: Latvia
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
state: LTU
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
city: Siauliai
country: Lithuania
facility: Novartis Investigative Site
city: Enschede
country: Netherlands
facility: Novartis Investigative Site
city: Sneek
country: Netherlands
facility: Novartis Investigative Site
city: Dopiewo
country: Poland
facility: Novartis Investigative Site
city: Szczecin
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Ponte de Lima
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Ekaterinburg
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: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Nizhny Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Petrozavodsk
country: Russian Federation
facility: Novartis Investigative Site
city: Rostov on Don
country: Russian Federation
facility: Novartis Investigative Site
city: Smolensk
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Partizanske
country: Slovakia
facility: Novartis Investigative Site
city: Topolcany
country: Slovakia
facility: Novartis Investigative Site
city: Cordoba
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Badalona
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: L Hospitalet De Llobregat
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Sabadell
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Santander
country: Spain
facility: Novartis Investigative Site
state: Cantabria
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Merida
country: Spain
facility: Novartis Investigative Site
state: Extremadura
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: La Laguna
country: Spain
facility: Novartis Investigative Site
state: Santa Cruz De Tenerife
city: Baracaldo
country: Spain
facility: Novartis Investigative Site
state: Vizcaya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Torquay
country: United Kingdom
facility: Novartis Investigative Site
state: Devon
city: Leytonstone
country: United Kingdom
facility: Novartis Investigative Site
state: London
city: Salford
country: United Kingdom
facility: Novartis Investigative Site
state: Manchester
city: Cannock
country: United Kingdom
facility: Novartis Investigative Site
state: Staffordshire
city: Stoke on Trent
country: United Kingdom
facility: Novartis Investigative Site
state: Staffordshire
city: Edinburgh
country: United Kingdom
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: Hull
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
city: Plymouth
country: United Kingdom
facility: Novartis Investigative Site
city: Solihull
country: United Kingdom
facility: Novartis Investigative Site
city: Wigan
country: United Kingdom
facility: Novartis Investigative Site
city: Wolverhampton
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: McInnes IB, Behrens F, Mease PJ, Kavanaugh A, Ritchlin C, Nash P, Masmitja JG, Goupille P, Korotaeva T, Gottlieb AB, Martin R, Ding K, Pellet P, Mpofu S, Pricop L; EXCEED Study Group. Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial. Lancet. 2020 May 9;395(10235):1496-1505. doi: 10.1016/S0140-6736(20)30564-X.