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.
A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Subjects With Active Radiographic Axial Spondyloarthritis
3 other identifiers
interventional
315
19 countries
148
Brief Summary
The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha) refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured by the reduction in signs and symptoms of radiographic 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
148 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
May 6, 2015
CompletedFirst Posted
Study publicly available on registry
May 8, 2015
CompletedStudy Start
First participant enrolled
July 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2017
CompletedResults Posted
Study results publicly available
October 1, 2018
CompletedApril 29, 2025
April 1, 2025
2.1 years
May 6, 2015
August 30, 2018
April 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24
ASAS 40 defined as improvement from baseline of greater than or equal to (\>=) 40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 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 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 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\[NRI(non responder imputation)\] (missing responses at post baseline visit imputed as non-responder).
Week(W) 24
Secondary Outcomes (10)
Percentage of Participants Who Achieved an ASAS 20 Response at Week 24
Week 24
Percentage of Participants Who Achieved at Least a 50 Percent (%) 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) Total Score at Week 24
Baseline and Week 24
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score-C Reactive Protein (ASDAS-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
- +5 more secondary outcomes
Study Arms (3)
Group 1 (placebo)
PLACEBO COMPARATORPlacebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) will be re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52. Participants who meet EE criteria (less than \[\<\] 10 percent \[%\] improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52.
Group 2 (ustekinumab 45 mg)
EXPERIMENTALUstekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 24, participants will receive placebo SC injection to maintain the blind. Participants who meet EE criteria (\<10% improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52.
Group 3 (ustekinumab 90 mg)
EXPERIMENTALUstekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 24, participants will receive placebo SC injection to maintain the blind. Participants who meet EE criteria (\<10% improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52.
Interventions
Ustekinumab 45 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52 in Group 1. Participants will start with ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52 in Group 2.
Ustekinumab 90 mg SC injection at Weeks 24 and 28 followed by q12w dosing, with the last administration of study agent at Week 52 in Group 1. Participants will start with ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52 in Group 3.
Participants who meet EE criteria (less than \[\<\] 10 percent \[%\] improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52 in Group 1, 2 and 3.
Eligibility Criteria
You may qualify if:
- Participants must have a diagnosis of definite ankylosing spondylitis (AS), as defined by the modified 1984 New York criteria. The radiographic criterion must be confirmed by a central xray reader and at least 1 clinical criterion must be met
- Participants must have symptoms of active disease at screening and at baseline, as evidenced by both a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to (\>=4) and a visual analog scale (VAS) score for total back pain of \>=4, each on a scale of 0 to 10
- Participants with elevated high sensitivity C-reactive protein (hsCRP) level of \>=0.300 milligram per deciliter (mg/dL) at screening
- Refractory by either lack of benefit or documented intolerance to 1 and no more than 1 anti-TNF(alpha) agent
- Inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over a 4-week period in total with maximal doses of NSAID(s), or is unable to receive a full 4 weeks of maximal NSAID therapy because of intolerance, toxicity, or contraindications to NSAIDs.
- Participants with complete ankylosis of the spine are permitted to be included in the study, but will be limited to approximately 10 percent (%) of the study population
You may not qualify if:
- Participants who have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy, including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, or Lyme disease
- Participants who have received infliximab or infliximab biosimilar, within 12 weeks of the first study agent administration; have received adalimumab, adalimumab biosimilar, or certolizumab pegol within 6 weeks of the first study agent administration; have received etanercept or etanercept biosimilar within 6 weeks of the first study agent administration
- Participants who have ever received golimumab
- Participants who are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 5 months after receiving the last administration of study agent
- Participants who have received any systemic immunosuppressives or disease-modifying antirheumatic drugs (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent. Medications in these categories include, but are not limited to leflunomide, chloroquine, azathioprine, cyclosporine, mycophenolate mofetil, gold, and penicillamine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (148)
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Glendale, Arizona, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Fremont, California, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Monroe, Louisiana, United States
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Eagan, Minnesota, United States
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Orchard Park, New York, United States
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Portland, Oregon, United States
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Duncansville, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Jackson, Tennessee, United States
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Austin, Texas, United States
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Mesquite, Texas, United States
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Arlington, Virginia, United States
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Seattle, Washington, United States
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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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Brussels, Belgium
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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 (Antwerp), Belgium
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Campinas, Brazil
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Curitiba, Brazil
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Goiânia, Brazil
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Juiz de Fora, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Santo André, Brazil
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São Paulo, Brazil
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Burgas, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Victoria, British Columbia, Canada
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St. John's, Newfoundland and Labrador, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Québec, Quebec, Canada
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Bruntál, 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, France
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Orléans, France
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Paris, France
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Rouen, France
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Toulouse, France
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Bad Neuheim, Germany
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Berlin, Germany
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Cologne, Germany
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Gommern, Germany
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Hamburg, Germany
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Herne, Germany
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Olsberg, Germany
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Ratingen, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Eger, 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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Culiacán, Mexico
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Guadalajara, Mexico
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Mexico City, Mexico
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Bialystok, Poland
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Bydgoszcz, Poland
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Elblag, Poland
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Nadarzyn, Poland
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Szczecin, Poland
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Torun, Poland
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Warsaw, Poland
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Almada, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Belgorod, Russia
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Chelyabinsk, Russia
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Chita, Russia
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Kazan', Russia
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Kemerovo, Russia
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Khanty-Mansiysk, Russia
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Kursk, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Omsk, Russia
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Orenburg, Russia
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Petrozavodsk, Russia
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Pyatigorsk, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Ufa, Russia
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Zelenograd, Russia
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Daegu, South Korea
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Daejeon, South Korea
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Gwangju, South Korea
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Jeonju, South Korea
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Seoul, South Korea
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Suwon, South Korea
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A Coruña, Spain
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Barcelona, Spain
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Bilbao, Spain
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Córdoba, Spain
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L'Hospitalet de Llobregat, Spain
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Madrid, Spain
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Málaga, Spain
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Sabadell, Spain
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Santiago de Compostela, Spain
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Seville, Spain
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Valencia, Spain
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Changhua, Taiwan
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Hualien City, Taiwan
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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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Cherkasy, Ukraine
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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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Poltava, Ukraine
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Ternopil, Ukraine
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Uzhhorod, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhya, Ukraine
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Bath, United Kingdom
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Leytonstone, United Kingdom
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London, United Kingdom
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Peterborough, United Kingdom
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Stoke-on-Trent, United Kingdom
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Upton, United Kingdom
Related Publications (2)
Kavanaugh A, Baraliakos X, Gao S, Chen W, Sweet K, Chakravarty SD, Song Q, Shawi M, Rahman P. Genetic and Molecular Distinctions Between Axial Psoriatic Arthritis and Radiographic Axial Spondyloarthritis: Post Hoc Analyses from Four Phase 3 Clinical Trials. Adv Ther. 2023 May;40(5):2439-2456. doi: 10.1007/s12325-023-02475-4. Epub 2023 Mar 30.
PMID: 36995469DERIVEDDeodhar 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was discontinued before it was fully enrolled due to lack of efficacy of either dose of ustekinumab in the CNTO1275AKS3001 (NCT02437162) study.
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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2015
First Posted
May 8, 2015
Study Start
July 31, 2015
Primary Completion
August 31, 2017
Study Completion
August 31, 2017
Last Updated
April 29, 2025
Results First Posted
October 1, 2018
Record last verified: 2025-04