Clinical trial NCT02721966: Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement
Official title: MAXIMISE (Managing AXIal Manifestations in PsorIatic Arthritis With SEcukinumab), a Randomized, Double-blind, Placebo-controlled, Multicenter, 52-week Study to Assess the Efficacy and Safety of Secukinumab 150 mg or 300 mg s.c. in Participants With Active Psoriatic Arthritis and Axial Skeleton Involvement Who Have Inadequate Response to Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Axial Psoratic Arthritis
Keywords: Assessment of spondyloarthritis international society
ASAS
axial
Psoriatic Arthritis
PsA
Magnetic resonance imaging
MRI
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-03-29
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 498 patients were randomized in this Phase 3b trial. 5 (of 503) were mis-randomized, i.e. received randomization number but never received study medication.

This was a 52-week, randomized, double-blind, double-dummy, placebo-controlled, multicenter study to assess the efficacy of secukinumab 150 mg or 300 mg in patients with AxPsA who had an inadequate response to NSAIDs. The study had 2 treatment periods; a placebo-controlled period from Baseline to Week 12 followed by an active treatment period from Week 12 to Week 52.

At Week 12, patients randomized to placebo at Baseline were re-randomized (1:1) to active treatment with secukinumab 150 mg or secukinumab 300 mg.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in PsA patients who have failed to respond to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according to assessment of spondyloarthritis international society (ASAS) recommendations for the treatment of axial spondyloarthritis (AxSpA).

Detailed description: In the anlalysis (CSR), there are 498 patients, as 5 patients were mis-randomized, i.e. had randomization number but did never take study medication. So there were 498 participants, and not 503

Eligibility criteria: Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed
* Diagnosis of psoriatic arthritis classified by Classification criteria for psoriatic arthritis (CASPAR) criteria
* Active spinal disease defined by Bath ankylosing spondylitis disease activity index (BASDAI) score ≥ 4
* Spinal Pain visual analog scale (VAS) ≥ 40 (on a VAS 100 scale)
* Inadequate Response to at least 2 non-steroidal anti-inflammatory drugs over a 4 weeks period

Exclusion Criteria:

* History of exposure to other IL-17 or IL-23 inhibitor biologic drug
* History of exposure to previous biologic disease modifying anti-rheumatic drugs (DMARDs) (Tumor necrosis factor (TNF) blockers or Ustekinumab)
* Current treatment with disease modifying anti-rheumatic drugs (DMARDs) other than Methotrexate
* Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
* Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician

Other protocol-defined inclusion and exclusion criteria may have applied.

Primary outcomes:
measure: Percentage of Participants With Response to Treatment (300 mg AIN457) as Assessed by the ASAS20 Criteria at Week 12
timeFrame: at week 12
Secondary outcomes:
measure: Percentage of Participants With Response to Treatment (150 mg AIN457) as Assessed by the ASAS20 Criteria at Week 12
timeFrame: at week 12
measure: Percentage of Participants With Response to Treatment (150 mg/300 mg AIN457) as Assessed by the ASAS40 Criteria at Week 12
timeFrame: at week 12
measure: Percentage of Participants With Response to Treatment as Assessed by BASDAI50 at Week 12
timeFrame: at week 12
measure: Change From Baseline in Spinal Pain Visual Analog Scale (VAS) - Pain at Any Time
timeFrame: at baseline, at week 12
measure: Change From Baseline in Spinal Pain Visual Analog Scale (VAS) - Pain at Night
timeFrame: at baseline, at week 12
measure: Change From Baseline Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index Score at Week 12
timeFrame: baseline and week 12
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12
timeFrame: baseline and week 12
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue) at Week 12
timeFrame: baseline and week 12
measure: Change From Baseline in Spondyloarthritis International Society (ASAS) Health Index at Week 12
timeFrame: baseline and week 12
measure: Percentage of Participants With Response to Treatment as Assessed by the ACR20 Criteria at Week 12
timeFrame: at week 12
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Ruse
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: Brno
country: Czechia
facility: Novartis Investigative Site
city: Bruntal
country: Czechia
facility: Novartis Investigative Site
city: Plzen-Bory
country: Czechia
facility: Novartis Investigative Site
city: Uherske Hradiste
country: Czechia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Kuopio
country: Finland
facility: Novartis Investigative Site
city: Kuovola
country: Finland
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
state: Cedex
city: Lyon
country: France
facility: Novartis Investigative Site
city: Nantes
country: France
facility: Novartis Investigative Site
city: PARIS Cedex 13
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex
country: France
facility: Novartis Investigative Site
city: Vandoeuvre Les Nancy
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Cottbus
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Eger
country: Hungary
facility: Novartis Investigative Site
city: Heviz
country: Hungary
facility: Novartis Investigative Site
city: Miskolc
country: Hungary
facility: Novartis Investigative Site
city: Veszprem
country: Hungary
facility: Novartis Investigative Site
city: Dublin 8
country: Ireland
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Kfar Saba
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: Bergamo
country: Italy
facility: Novartis Investigative Site
state: BG
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Verona
country: Italy
facility: Novartis Investigative Site
state: VR
city: Bologna
country: Italy
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Bydgoszcz
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Piotrkow Trybunalski
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
city: Cluj Napoca
country: Romania
facility: Novartis Investigative Site
city: Izhevsk
country: Russian Federation
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Khanty-Mansiysk
country: Russian Federation
facility: Novartis Investigative Site
city: Kursk
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: Novosibirsk
country: Russian Federation
facility: Novartis Investigative Site
city: Orenburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saratov
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Elche
country: Spain
facility: Novartis Investigative Site
state: Alicante
city: Cordoba
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Terrassa
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Santander
country: Spain
facility: Novartis Investigative Site
state: Cantabria
city: Salamanca
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Lugo
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Las Palmas de Gran Canaria
country: Spain
facility: Novartis Investigative Site
state: Las Palmas De G.C
city: El Palmar
country: Spain
facility: Novartis Investigative Site
state: Murcia
city: A Coruna
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Pontevedra
country: Spain
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
city: Vitoria Gasteiz
country: Spain
facility: Novartis Investigative Site
city: Fribourg
country: Switzerland
facility: Novartis Investigative Site
state: CH
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: St Gallen
country: Switzerland
facility: Novartis Investigative Site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
city: Devon
country: United Kingdom
facility: Novartis Investigative Site
state: Barnstaple
city: Basingstoke
country: United Kingdom
facility: Novartis Investigative Site
state: Hampshire
city: Maidstone
country: United Kingdom
facility: Novartis Investigative Site
state: Kent
city: Leytonstone
country: United Kingdom
facility: Novartis Investigative Site
state: London
city: Bradford
country: United Kingdom
facility: Novartis Investigative Site
state: West Yorkshire
city: Leeds
country: United Kingdom
facility: Novartis Investigative Site
state: West Yorkshire
city: Hull
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:
References:
citation: Baraliakos X, Gossec L, Pournara E, Jeka S, Mera-Varela A, D'Angelo S, Schulz B, Rissler M, Nagar K, Perella C, Coates LC. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021 May;80(5):582-590. doi: 10.1136/annrheumdis-2020-218808. Epub 2020 Dec 17.