A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Ustekinumab, a Fully Human Aanti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis
3 other identifiers
interventional
615
13 countries
96
Brief Summary
The purpose of this study is to evaluate the effectiveness (improvement of signs and symptoms) and safety of ustekinumab in participants with active psoriatic arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2009
Typical duration for phase_3
96 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
November 5, 2009
CompletedFirst Posted
Study publicly available on registry
November 6, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
March 13, 2014
CompletedMarch 3, 2015
February 1, 2015
1.8 years
November 5, 2009
October 11, 2013
February 11, 2015
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 centimeters \[cm\]) 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
Percentage of Participants With American College of Rheumatology (ACR) 70 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
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 88. 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 88. 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 88. 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 88. 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 88. 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
- If the participant is using methotrexate they should have started treatment at a dose not to exceed 25 milligram per week at least 3 months prior to the beginning of the study and should have no serious toxic side effects attributable to methotrexate. Methotrexate route of administration and doses should be stable for at least 4 weeks prior to the first administration of study agent. If currently not using methotrexate, must have not received methotrexate for at least 4 weeks prior to the first administration of the study agent
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 interleukin (IL)-12 or IL-23, including but not limited to ustekinumab and briakinumab (ABT-874)
- Have used any biologic agents that are targeted for reducing tumor necrosis factor-alpha, including but not limited to infliximab, etanercept, adalimumab, and golimumab
- Have a medical history of latent or active granulomatous infection
- 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 (102)
Unknown Facility
Encinitas, California, United States
Unknown Facility
La Jolla, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Trumbull, Connecticut, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Wheaton, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Fall River, Massachusetts, United States
Unknown Facility
Worcester, Massachusetts, United States
Unknown Facility
Edina, Minnesota, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Freehold, New Jersey, United States
Unknown Facility
Norman, Oklahoma, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Duncansville, Pennsylvania, United States
Unknown Facility
Wyomissing, Pennsylvania, United States
Unknown Facility
Jackson, Tennessee, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Webster, Texas, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Camperdown, Australia
Unknown Facility
Heidelberg, Australia
Unknown Facility
Maroochydore, Australia
Unknown Facility
Melbourne, Australia
Unknown Facility
Perth, Australia
Unknown Facility
Woodville, Australia
Unknown Facility
Graz, Austria
Unknown Facility
Innsbruck, Austria
Unknown Facility
Vienna, Austria
Unknown Facility
Edmonton, Alberta, Canada
Unknown Facility
Kelowna, British Columbia, Canada
Unknown Facility
Vancouver, British Columbia, Canada
Unknown Facility
Moncton, New Brunswick, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, Canada
Unknown Facility
Halifax, Nova Scotia, Canada
Unknown Facility
Barrie, Ontario, Canada
Unknown Facility
Hamilton, Ontario, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
North Bay, Ontario, Canada
Unknown Facility
Saint Catherines, Ontario, Canada
Unknown Facility
Sarnia, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Waterloo, Ontario, Canada
Unknown Facility
Windsor, Ontario, Canada
Unknown Facility
Québec, Quebec, Canada
Unknown Facility
Trois-Rivières, Quebec, Canada
Unknown Facility
Westmount, Quebec, Canada
Unknown Facility
Helsinki, Finland
Unknown Facility
Hyvinkää, Finland
Unknown Facility
Berlin, Germany
Unknown Facility
Frankfurt, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Herne, Germany
Unknown Facility
Kiel, Germany
Unknown Facility
Mahlow, Germany
Unknown Facility
Mainz, Germany
Unknown Facility
Regensburg, Germany
Unknown Facility
TĂ¼bingen, Germany
Unknown Facility
Budapest, Hungary
Unknown Facility
Debrecen, Hungary
Unknown Facility
Kecskemét, Hungary
Unknown Facility
Szeged, Hungary
Unknown Facility
Szolnok, Hungary
Unknown Facility
Veszprém, Hungary
Unknown Facility
Riga, Latvia
Unknown Facility
Alytus, Lithuania
Unknown Facility
Kaunas, Lithuania
Unknown Facility
KlaipÄ—da, Lithuania
Unknown Facility
Å iauliai, Lithuania
Unknown Facility
Auckland, New Zealand
Unknown Facility
Christchurch, New Zealand
Unknown Facility
Rotorua, New Zealand
Unknown Facility
Wellington, New Zealand
Unknown Facility
Bialystok, Poland
Unknown Facility
Bydgoszcz, Poland
Unknown Facility
Elblag, Poland
Unknown Facility
Lublin, Poland
Unknown Facility
Torun, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Korolyov, Russia
Unknown Facility
Moscow, Russia
Unknown Facility
Novosibirsk, Russia
Unknown Facility
Rostov-on-Don, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Saratov, Russia
Unknown Facility
Yekaterinburg, Russia
Unknown Facility
Barcelona, Spain
Unknown Facility
Oviedo, Spain
Unknown Facility
Santiago de Compostela, Spain
Unknown Facility
Seville, Spain
Unknown Facility
Cannock, United Kingdom
Unknown Facility
Glasgow, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Metropolitan Borough of Wirral, United Kingdom
Unknown Facility
Salford, United Kingdom
Unknown Facility
Wigan, United Kingdom
Related Publications (8)
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: 27098404DERIVEDKavanaugh A, Puig L, Gottlieb AB, Ritchlin C, Li S, Wang Y, Mendelsohn AM, Song M, Zhu Y, Rahman P, McInnes IB; PSUMMIT 1 Study Group. Maintenance of Clinical Efficacy and Radiographic Benefit Through Two Years of Ustekinumab Therapy in Patients With Active Psoriatic Arthritis: Results From a Randomized, Placebo-Controlled Phase III Trial. Arthritis Care Res (Hoboken). 2015 Dec;67(12):1739-49. doi: 10.1002/acr.22645.
PMID: 26097039DERIVEDMcInnes IB, Kavanaugh A, Gottlieb AB, Puig L, Rahman P, Ritchlin C, Brodmerkel C, Li S, Wang Y, Mendelsohn AM, Doyle MK; PSUMMIT 1 Study Group. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet. 2013 Aug 31;382(9894):780-9. doi: 10.1016/S0140-6736(13)60594-2. Epub 2013 Jun 13.
PMID: 23769296DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- 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
November 5, 2009
First Posted
November 6, 2009
Study Start
December 1, 2009
Primary Completion
October 1, 2011
Study Completion
May 1, 2013
Last Updated
March 3, 2015
Results First Posted
March 13, 2014
Record last verified: 2015-02