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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02407223




Registration number
NCT02407223
Ethics application status
Date submitted
30/03/2015
Date registered
2/04/2015
Date last updated
13/03/2019

Titles & IDs
Public title
An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis
Scientific 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
Secondary ID [1] 0 0
CNTO1275AKS3003
Secondary ID [2] 0 0
CR106995
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonradiographic Axial Spondylitis, Ankylosing 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Group 1: Placebo
Treatment: Drugs - Group 2: Ustekinumab 45 mg
Treatment: Drugs - Group 3: Ustekinumab 90 mg

Placebo comparator: Group 1: Placebo - Participants will receive placebo subcutaneously (SC) at Weeks 0, 4, 16, and 20. At Week 24, all participants (except those who early escaped) will crossover to receive ustekinumab 45 or 90 milligram (mg) SC at Weeks 24 and 28 followed by every 12 weeks up to Week 52. At Week 16, participants in placebo group with \< 10% improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16 will enter early escape to receive ustekinumab 45 mg or 90 mg at Weeks 16, 20, and 28 followed by every 12 weeks up to Week 52. At Week 52, participants who achieved inactive disease by ASDAS (ESR) \<1.3 at both Week 40 and 52 will be re-randomized to receive placebo or ustekinumab every 12 weeks up to Week 88. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) \<1.3 at Week 40 or 52 will continue with ustekinumab every 12 weeks up to Week 88. NOTE: Intervention Description should have no more than 800 characters.

Experimental: Group 2: Ustekinumab 45 milligram (mg) - Participants will receive ustekinumab 45 mg subcutaneously at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants will receive placebo subcutaneously to maintain the blind. At Week 52, participants who achieved inactive disease by ASDAS (ESR) \<1.3 at both Week 40 and Week 52 will be re-randomized to receive either placebo or ustekinumab 45 mg every 12 weeks in a blinded fashion. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) \<1.3 at Week 40 or Week 52 will continue receiving ustekinumab 45 mg every 12 weeks through Week 88.

Experimental: Group 3: Ustekinumab 90 mg - Participants will receive ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants will receive placebo subcutaneously to maintain the blind. At Week 52, participants who achieved inactive disease by ASDAS (ESR) \<1.3 at both Week 40 and Week 52 will receive either placebo or ustekinumab 90 mg every 12 weeks in a blinded fashion. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) \<1.3 at Week 40 or Week 52 will continue receiving ustekinumab 90 mg every 12 weeks through Week 88.


Treatment: Drugs: Group 1: Placebo
Participants will receive placebo SC at Weeks 0, 4, 16, and 20. At Week 24, all participants (except those who early escaped) will crossover to receive ustekinumab 45 or 90 mg SC at Weeks 24 and 28 followed by every 12 weeks up to Week 52. At Week 16, participants in placebo group with \< 10% improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16 will enter early escape to receive ustekinumab 45 mg or 90 mg at Weeks 16, 20, and 28 followed by every 12 weeks up to Week 52. At Week 52, participants who achieved inactive disease by ASDAS (ESR) \<1.3 at both Week 40 and 52 will be re-randomized to receive placebo or ustekinumab every 12 weeks up to Week 88. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) \<1.3 at Week 40 or 52 will continue with ustekinumab every 12 weeks up to Week 88.

Treatment: Drugs: Group 2: Ustekinumab 45 mg
Participants will receive ustekinumab 45 mg subcutaneously at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants will receive placebo subcutaneously to maintain the blind. At Week 52, participants who achieved inactive disease by ASDAS (ESR) \<1.3 at both Week 40 and Week 52 will be re-randomized to receive either placebo or ustekinumab 45 mg every 12 weeks in a blinded fashion. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) \<1.3 at Week 40 or Week 52 will continue receiving ustekinumab 45 mg every 12 weeks through Week 88.

Treatment: Drugs: Group 3: Ustekinumab 90 mg
Participants will receive ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants will receive placebo subcutaneously to maintain the blind. At Week 52, participants who achieved inactive disease by ASDAS (ESR) \<1.3 at both Week 40 and Week 52 will receive either placebo or ustekinumab 90 mg every 12 weeks in a blinded fashion. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) \<1.3 at Week 40 or Week 52 will continue receiving ustekinumab 90 mg every 12 weeks through Week 88.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved an ASAS 40 Response at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24
Timepoint [3] 0 0
Baseline, Week 24
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-reactive Protein (CRP) Inactive Disease (<1.3) at Week 24
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24
Timepoint [5] 0 0
Baseline, Week 4, 8, 12, 16, 20 and 24
Secondary outcome [6] 0 0
Percentage of Participants With ASAS 20 Components at Week 24
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20
Timepoint [7] 0 0
Week 4, 8, 12, 16 and 20
Secondary outcome [8] 0 0
Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20
Timepoint [8] 0 0
Week 4, 8, 12, 16 and 20
Secondary outcome [9] 0 0
Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20
Timepoint [9] 0 0
Week 4, 8, 12, 16, and 20
Secondary outcome [10] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 4, 8, 12, 16 and 20
Timepoint [10] 0 0
Baseline, Week 4, 8, 12, 16 and 20
Secondary outcome [11] 0 0
Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16, and 20
Timepoint [11] 0 0
Week 4, 8, 12, 16, and 20

Eligibility
Key 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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-TNFa
* Have received more than 1 prior anti-TNFa agent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/09/2017
Sample size
Target
Accrual to date
Final
356
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Geelong
Recruitment hospital [2] 0 0
- Hobart
Recruitment hospital [3] 0 0
- Kogarah
Recruitment hospital [4] 0 0
- Queensland
Recruitment hospital [5] 0 0
- Woodville South
Recruitment hospital [6] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Geelong
Recruitment postcode(s) [2] 0 0
- Hobart
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment postcode(s) [4] 0 0
- Queensland
Recruitment postcode(s) [5] 0 0
- Woodville South
Recruitment postcode(s) [6] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciudad De Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Ciudad De La Plata
Country [4] 0 0
Argentina
State/province [4] 0 0
Ciudad De San Miguel De Tucuman
Country [5] 0 0
Argentina
State/province [5] 0 0
Cordoba
Country [6] 0 0
Belgium
State/province [6] 0 0
Genk
Country [7] 0 0
Belgium
State/province [7] 0 0
Gent
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Belgium
State/province [9] 0 0
Liège
Country [10] 0 0
Belgium
State/province [10] 0 0
Merksem
Country [11] 0 0
Czechia
State/province [11] 0 0
Brno
Country [12] 0 0
Czechia
State/province [12] 0 0
Bruntal
Country [13] 0 0
Czechia
State/province [13] 0 0
Kladno
Country [14] 0 0
Czechia
State/province [14] 0 0
Ostrava
Country [15] 0 0
Czechia
State/province [15] 0 0
Pardubice
Country [16] 0 0
Czechia
State/province [16] 0 0
Prague 5
Country [17] 0 0
Czechia
State/province [17] 0 0
Praha 2
Country [18] 0 0
Czechia
State/province [18] 0 0
Praha 4
Country [19] 0 0
Czechia
State/province [19] 0 0
Uherske Hradiste
Country [20] 0 0
Czechia
State/province [20] 0 0
Zlin
Country [21] 0 0
France
State/province [21] 0 0
Boulogne-Billancourt
Country [22] 0 0
France
State/province [22] 0 0
Chambray Les Tours
Country [23] 0 0
France
State/province [23] 0 0
Echirolles
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France
State/province [24] 0 0
Montpellier, Herault
Country [25] 0 0
France
State/province [25] 0 0
Paris
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France
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Toulouse
Country [27] 0 0
Germany
State/province [27] 0 0
Bad Nauheim
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Hamburg
Country [30] 0 0
Germany
State/province [30] 0 0
Hannover
Country [31] 0 0
Germany
State/province [31] 0 0
Herne
Country [32] 0 0
Germany
State/province [32] 0 0
Köln
Country [33] 0 0
Germany
State/province [33] 0 0
Olsberg
Country [34] 0 0
Hungary
State/province [34] 0 0
Budapest
Country [35] 0 0
Hungary
State/province [35] 0 0
Debrecen
Country [36] 0 0
Hungary
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Esztergom
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Hungary
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Kistarcsa
Country [38] 0 0
Hungary
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Nyíregyháza
Country [39] 0 0
Hungary
State/province [39] 0 0
Szolnok
Country [40] 0 0
Hungary
State/province [40] 0 0
Székesfehérvár
Country [41] 0 0
Hungary
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Veszprem
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Mexico
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Chihuahua
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Mexico
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Culiacan
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Mexico
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Guadalajara
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Mexico
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Mexico
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Poland
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Bydgoszcz
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Poland
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Szczecin
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Poland
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Torun
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Poland
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Warszawa
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Poland
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Wroclaw
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Russian Federation
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Chelyabinsk
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Russian Federation
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Chita
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Russian Federation
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Kemerovo
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Russian Federation
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Kirov
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Orenburg
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Russian Federation
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Petrozavodsk
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Russian Federation
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Sankt-Petersburg.
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Russian Federation
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Saratov
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Russian Federation
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St.Petersburg
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Stavropol
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Ulyanovsk
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Russian Federation
State/province [67] 0 0
Zelenograd
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Taiwan
State/province [68] 0 0
Kaohsiung
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Taiwan
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Taichung
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Taiwan
State/province [70] 0 0
Tainan
Country [71] 0 0
Taiwan
State/province [71] 0 0
Taipei
Country [72] 0 0
Taiwan
State/province [72] 0 0
Taoyuan
Country [73] 0 0
Ukraine
State/province [73] 0 0
Ivano-Frankivsk
Country [74] 0 0
Ukraine
State/province [74] 0 0
Kharkiv
Country [75] 0 0
Ukraine
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Kyiv
Country [76] 0 0
Ukraine
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Lviv
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Ukraine
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Odessa
Country [78] 0 0
Ukraine
State/province [78] 0 0
Ternopil
Country [79] 0 0
Ukraine
State/province [79] 0 0
Vinnytsya
Country [80] 0 0
Ukraine
State/province [80] 0 0
Zaporizhzhya
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Bath
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Leeds
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Leytonstone
Country [84] 0 0
United Kingdom
State/province [84] 0 0
London
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Norwich
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Staffordshire
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Torquay

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT02407223
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02407223