Clinical trial NCT02407223: An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Subjects With Active Nonradiographic Axial Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Nonradiographic Axial Spondylitis, Ankylosing
Keywords: Nonradiographic Axial Spondylitis, Ankylosing
Ustekinumab
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2015-04-02
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of ustekinumab in adult participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA).

Detailed description: This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of ustekinumab in the treatment of participants with active non-radiographic axial spondylo arthritis. Participants will receive either placebo or ustekinumab 45 or 90 milligram (mg). Participants will primarily be assessed for Assessment of Spondylo Arthritis (ASAS) International Society criteria 20 at Week 24. Safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Participants must be classified as having nonradiographic axial spondyloarthritis (nr-AxSpA) based on 2009 Assessment of SpondyloArthritis International Society (ASAS) criteria
* Must have an age at nr-AxSpA onset of \<= 45 years
* Must have at screening or active inflammation on magnetic resonance imaging (MRI) as evidenced by the central readers and no radiographic sacroiliitis that fulfills the 1984 modified New York Criteria
* Must have symptoms of active disease at screening and at baseline, as evidenced by both a BASDAI score of \>= 4 and a visual analogue scale (VAS) score for total back pain of more than or equal to (\>=) 4, each on a scale of 0 to 10

Exclusion Criteria:

* Have radiographic sacroiliitis fulfilling the 1984 modified New York Criteria
* Have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy
* Have received any systemic immunosuppressives or disease-modifying anti-rheumatic drug (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent
* Have received epidural, intra-articular, intramuscular (IM), or intravenous (IV) corticosteroids, including adrenocorticotropic hormone during the 4 weeks prior to first administration of study agent
* Have received prior biologic therapy other than anti-TNFα
* Have received more than 1 prior anti-TNFα agent

Primary outcomes:
measure: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants Who Achieved an ASAS 40 Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
timeFrame: Week 24
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-reactive Protein (CRP) Inactive Disease (<1.3) at Week 24
timeFrame: Week 24
measure: Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24
timeFrame: Baseline, Week 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With ASAS 20 Components at Week 24
timeFrame: Week 24
measure: Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20
timeFrame: Week 4, 8, 12, 16 and 20
measure: Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20
timeFrame: Week 4, 8, 12, 16 and 20
measure: Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20
timeFrame: Week 4, 8, 12, 16, and 20
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 4, 8, 12, 16 and 20
timeFrame: Baseline, Week 4, 8, 12, 16 and 20
measure: Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16, and 20
timeFrame: Week 4, 8, 12, 16, and 20
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Ciudad De Buenos Aires
country: Argentina
city: Ciudad De La Plata
country: Argentina
city: Ciudad De San Miguel De Tucuman
country: Argentina
city: Cordoba
country: Argentina
city: Geelong
country: Australia
city: Hobart
country: Australia
city: Kogarah
country: Australia
city: Queensland
country: Australia
city: Woodville South
country: Australia
city: Woolloongabba
country: Australia
city: Genk
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Liège
country: Belgium
city: Merksem
country: Belgium
city: Brno
country: Czechia
city: Bruntal
country: Czechia
city: Kladno
country: Czechia
city: Ostrava
country: Czechia
city: Pardubice
country: Czechia
city: Prague 5
country: Czechia
city: Praha 2
country: Czechia
city: Praha 4
country: Czechia
city: Uherske Hradiste
country: Czechia
city: Zlin
country: Czechia
city: Boulogne-Billancourt
country: France
city: Chambray Les Tours
country: France
city: Echirolles
country: France
city: Montpellier, Herault
country: France
city: Paris
country: France
city: Toulouse
country: France
city: Bad Nauheim
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Herne
country: Germany
city: Köln
country: Germany
city: Olsberg
country: Germany
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Esztergom
country: Hungary
city: Kistarcsa
country: Hungary
city: Nyíregyháza
country: Hungary
city: Szolnok
country: Hungary
city: Székesfehérvár
country: Hungary
city: Veszprem
country: Hungary
city: Gwangju
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Chihuahua
country: Mexico
city: Culiacan
country: Mexico
city: Guadalajara
country: Mexico
city: Mexico
country: Mexico
city: Bydgoszcz
country: Poland
city: Szczecin
country: Poland
city: Torun
country: Poland
city: Warszawa
country: Poland
city: Wrocław
country: Poland
city: Chelyabinsk
country: Russian Federation
city: Chita
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Kirov
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Orenburg
country: Russian Federation
city: Petrozavodsk
country: Russian Federation
city: Sankt-Petersburg.
country: Russian Federation
city: Saratov
country: Russian Federation
city: St.Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Ulyanovsk
country: Russian Federation
city: Zelenograd
country: Russian Federation
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Ternopil
country: Ukraine
city: Vinnytsya
country: Ukraine
city: Zaporizhzhya
country: Ukraine
city: Bath
country: United Kingdom
city: Leeds
country: United Kingdom
city: Leytonstone
country: United Kingdom
city: London
country: United Kingdom
city: Norwich
country: United Kingdom
city: Staffordshire
country: United Kingdom
city: Torquay
country: United Kingdom
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Deodhar A, Gensler LS, Sieper J, Clark M, Calderon C, Wang Y, Zhou Y, Leu JH, Campbell K, Sweet K, Harrison DD, Hsia EC, van der Heijde D. Three Multicenter, Randomized, Double-Blind, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis. Arthritis Rheumatol. 2019 Feb;71(2):258-270. doi: 10.1002/art.40728. Epub 2018 Dec 29.