Study Stopped
This study was stopped because ustekinumab did not achieve key endpoints in a related study. The safety profile was consistent with past ustekinumab studies.
An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis
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
3 other identifiers
interventional
356
14 countries
90
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2015
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2015
CompletedFirst Posted
Study publicly available on registry
April 2, 2015
CompletedStudy Start
First participant enrolled
July 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2017
CompletedResults Posted
Study results publicly available
March 13, 2019
CompletedMarch 13, 2019
February 1, 2019
2.2 years
March 30, 2015
September 26, 2018
March 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24
ASAS 20 defined as improvement of greater than or equal to (\>=) 20 % from baseline and absolute improvement from baseline of 1 on a 0 to 10 centimeter(cm) scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor), total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 to participant's ability to cope with everyday life), Inflammation (0 to 10 cm;0=none,10=very severe); absence of deterioration (\>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in remaining domain. ASAS20 response based on imputed data using treatment failure (consider non-responders at and after treatment failure),early escape rules (consider non-responder at Week 20 and 24),non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder).
Week 24
Secondary Outcomes (11)
Percentage of Participants Who Achieved an ASAS 40 Response at Week 24
Week 24
Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
Week 24
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24
Baseline, Week 24
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-reactive Protein (CRP) Inactive Disease (<1.3) at Week 24
Week 24
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24
Baseline, Week 4, 8, 12, 16, 20 and 24
- +6 more secondary outcomes
Study Arms (3)
Group 1: Placebo
PLACEBO COMPARATORParticipants 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.
Group 2: Ustekinumab 45 milligram (mg)
EXPERIMENTALParticipants 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.
Group 3: Ustekinumab 90 mg
EXPERIMENTALParticipants 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (90)
Unknown Facility
Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Ciudad de La Plata, Argentina
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Ciudad de San Miguel de Tucuman, Argentina
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Córdoba, Argentina
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Geelong, Australia
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Hobart, Australia
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Kogarah, Australia
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Queensland, Australia
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Woodville South, Australia
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Woolloongabba, Australia
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Genk, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Merksem, Belgium
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Brno, Czechia
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Bruntál, Czechia
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Kladno, Czechia
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Ostrava, Czechia
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Pardubice, Czechia
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Prague, Czechia
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Uherské Hradiště, Czechia
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Zlín, Czechia
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Boulogne-Billancourt, France
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Chambray-lès-Tours, France
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Échirolles, France
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Montpellier, Herault, France
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Paris, France
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Toulouse, France
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Bad Nauheim, Germany
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Berlin, Germany
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Cologne, Germany
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Hamburg, Germany
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Hanover, Germany
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Herne, Germany
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Olsberg, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Esztergom, Hungary
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Kistarcsa, Hungary
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Nyíregyháza, Hungary
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Székesfehérvár, Hungary
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Szolnok, Hungary
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Veszprém, Hungary
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Chihuahua City, Mexico
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Culiacán, Mexico
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Guadalajara, Mexico
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México, Mexico
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Bydgoszcz, Poland
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Szczecin, Poland
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Torun, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Chelyabinsk, Russia
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Chita, Russia
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Kemerovo, Russia
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Kirov, Russia
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Moscow, Russia
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Novosibirsk, Russia
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Orenburg, Russia
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Petrozavodsk, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Stavropol, Russia
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Ulyanovsk, Russia
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Zelenograd, Russia
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Gwangju, South Korea
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Incheon, South Korea
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Seoul, South Korea
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Ternopil, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhya, Ukraine
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Bath, United Kingdom
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Leeds, United Kingdom
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Leytonstone, United Kingdom
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London, United Kingdom
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Norwich, United Kingdom
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Staffordshire, United Kingdom
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Torquay, United Kingdom
Related Publications (1)
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.
PMID: 30225992DERIVED
Limitations and Caveats
The study was discontinued before it was fully enrolled, therefore, the interpretation of the efficacy data is limited.
Results Point of Contact
- Title
- Scientific Director
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2015
First Posted
April 2, 2015
Study Start
July 13, 2015
Primary Completion
September 26, 2017
Study Completion
September 26, 2017
Last Updated
March 13, 2019
Results First Posted
March 13, 2019
Record last verified: 2019-02