A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Ustekinumab, a Fully Human Anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-TNFalpha Agent(s)
3 other identifiers
interventional
312
10 countries
80
Brief Summary
The purpose of this study is to evaluate the efficacy (improvement of signs and symptoms) and safety of ustekinumab in patients with psoriatic arthritis.
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 Mar 2010
Typical duration for phase_3
80 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
February 25, 2010
CompletedFirst Posted
Study publicly available on registry
March 1, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
February 27, 2014
CompletedFebruary 27, 2014
January 1, 2014
2 years
February 25, 2010
October 11, 2013
January 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.
An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 20 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein.
Week 24
Secondary Outcomes (5)
Change From Baseline to Week 24 in the Disability Index Score as Measured With the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI)
Day 1 (Baseline) and Week 24
Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24
Week 24
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24
Week 24
Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002
Day 1 (Baseline) and Week 24
Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24
Week 24
Study Arms (3)
Placebo
EXPERIMENTALParticipants will receive subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants will cross over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab will be given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection will be given at Week 24 to maintain the blind.
Ustekinumab 45 mg
EXPERIMENTALParticipants will receive SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab will be given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants will receive SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Ustekinumab 90 mg
EXPERIMENTALParticipants will receive SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule will continue. Participants will receive SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Interventions
Eligibility Criteria
You may qualify if:
- Have had a documented diagnosis of psoriatic arthritis (PsA) at least 6 months
- Have a diagnosis of active PsA at the time of entry into the study with at least 5 tender and 5 swollen joints at baseline
- May have previously received at least 8 weeks of etanercept, adalimumab, golimumab or certolizumab pegol or at least 14 weeks of infliximab or proven inability to tolerate anti-TNF therapy for 8-14 weeks
- If the patient is using methotrexate, they should have started treatment at a dose not to exceed 25 mg/week at least 3 months prior to the beginning of the study and should have no serious toxic side effects attributable to methotrexate
You may not qualify if:
- Have other inflammatory diseases, including but not limited to rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease
- Have used any therapeutic agent targeted at reducing IL-12 or IL-23, including but not limited to ustekinumab and ABT-874
- Have used infliximab, golimumab or certolizumab pegol within 12 weeks of first study drug injection, or etanercept or adalimumab within 8 weeks of first study drug injection
- Have a medical history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening
- Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years of the beginning of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (80)
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Denver, Colorado, United States
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Trumbull, Connecticut, United States
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Tampa, Florida, United States
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Indianapolis, Indiana, United States
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New Orleans, Louisiana, United States
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Wheaton, Maryland, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
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Edina, Minnesota, United States
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Clayton, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Freehold, New Jersey, United States
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Orchard Park, New York, United States
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Rochester, New York, United States
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Cleveland, Ohio, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Duncansville, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Dallas, Texas, United States
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Graz, Austria
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Sankt Pölten, Austria
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Vienna, Austria
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Edmonton, Alberta, Canada
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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St. John's, Newfoundland and Labrador, Canada
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Barrie, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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North Bay, Ontario, Canada
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Saint Catherines, Ontario, Canada
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Sarnia, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Bordeaux, France
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Chambray-lès-Tours, France
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Créteil, France
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Lille, France
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Paris, France
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Toulouse, France
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Berlin, Germany
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Cologne, Germany
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Erlangen, Germany
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Hamburg, Germany
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Herne, Germany
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München, Germany
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Debrecen, Hungary
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Szombathely, Hungary
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Veszprém, Hungary
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Bialystok, Poland
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Bydgoszcz, Poland
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Lublin, Poland
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Warsaw, Poland
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Moscow, Russia
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Saint Petersburg, Russia
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Yekaterinburg, Russia
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Gothenburg, Sweden
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Malmo, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Cannock, United Kingdom
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Glasgow, United Kingdom
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London, United Kingdom
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Metropolitan Borough of Wirral, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Salford, United Kingdom
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Sheffield, United Kingdom
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Southampton, United Kingdom
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Westcliff-on-Sea, United Kingdom
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Wigan, United Kingdom
Related Publications (6)
Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Ustekinumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Oct;11(5):1413-1423. doi: 10.1007/s40744-024-00705-x. Epub 2024 Aug 9.
PMID: 39120848DERIVEDHelliwell PS, Gladman DD, Chakravarty SD, Kafka S, Karyekar CS, You Y, Campbell K, Sweet K, Kavanaugh A, Gensler LS. Effects of ustekinumab on spondylitis-associated endpoints in TNFi-naive active psoriatic arthritis patients with physician-reported spondylitis: pooled results from two phase 3, randomised, controlled trials. RMD Open. 2020 Feb;6(1):e001149. doi: 10.1136/rmdopen-2019-001149.
PMID: 32209721DERIVEDSiebert S, Sweet K, Dasgupta B, Campbell K, McInnes IB, Loza MJ. Responsiveness of Serum C-Reactive Protein, Interleukin-17A, and Interleukin-17F Levels to Ustekinumab in Psoriatic Arthritis: Lessons From Two Phase III, Multicenter, Double-Blind, Placebo-Controlled Trials. Arthritis Rheumatol. 2019 Oct;71(10):1660-1669. doi: 10.1002/art.40921. Epub 2019 Sep 3.
PMID: 31070869DERIVEDGhosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3.
PMID: 30739254DERIVEDRahman P, Puig L, Gottlieb AB, Kavanaugh A, McInnes IB, Ritchlin C, Li S, Wang Y, Song M, Mendelsohn A, Han C; PSUMMIT 1 and 2 Study Groups. Ustekinumab Treatment and Improvement of Physical Function and Health-Related Quality of Life in Patients With Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2016 Dec;68(12):1812-1822. doi: 10.1002/acr.23000. Epub 2016 Oct 21.
PMID: 27483458DERIVEDKavanaugh A, Puig L, Gottlieb AB, Ritchlin C, You Y, Li S, Song M, Randazzo B, Rahman P, McInnes IB. Efficacy and safety of ustekinumab in psoriatic arthritis patients with peripheral arthritis and physician-reported spondylitis: post-hoc analyses from two phase III, multicentre, double-blind, placebo-controlled studies (PSUMMIT-1/PSUMMIT-2). Ann Rheum Dis. 2016 Nov;75(11):1984-1988. doi: 10.1136/annrheumdis-2015-209068. Epub 2016 Apr 20.
PMID: 27098404DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director, Clinical Research
- 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
February 25, 2010
First Posted
March 1, 2010
Study Start
March 1, 2010
Primary Completion
March 1, 2012
Study Completion
November 1, 2012
Last Updated
February 27, 2014
Results First Posted
February 27, 2014
Record last verified: 2014-01