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Arthritis, PsoriaticPhase 3NCT01009086

A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis

A Phase 3 study testing Ustekinumab 45 mg and Ustekinumab 90 mg in people with Arthritis, Psoriatic, run by Janssen Research & Development, LLC at 102 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Psoriatic
What is being tested?
Ustekinumab 45 mg and Ustekinumab 90 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
615 participants
Where
102 sitesin 14 countries
Study dates
Dec 2009to May 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

102 sites in 14 countries.

102 sites in 14 countries

United States26 sites

  • Study site

    Boston, Massachusetts

  • Study site

    Chicago, Illinois

  • Study site

    Denver, Colorado

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Edina, Minnesota

  • Study site

    Encinitas, California

  • Study site

    Fall River, Massachusetts

  • Study site

    Freehold, New Jersey

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Jackson, Tennessee

  • Study site

    La Jolla, California

  • Study site

    New Orleans, Louisiana

  • Study site

    Norman, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Portland, Oregon

  • Study site

    San Diego, California

  • Study site

    Seattle, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Tampa, Florida

  • Study site

    Trumbull, Connecticut

  • Study site

    Tulsa, Oklahoma

  • Study site

    Webster, Texas

  • Study site

    Wheaton, Maryland

  • Study site

    Worcester, Massachusetts

  • Study site

    Wyomissing, Pennsylvania

Other trials in United States

Canada18 sites

  • Study site

    Barrie, Ontario

  • Study site

    Edmonton, Alberta

  • Study site

    Halifax, Nova Scotia

  • Study site

    Hamilton, Ontario

  • Study site

    Kelowna, British Columbia

  • Study site

    London, Ontario

  • Study site

    Moncton, New Brunswick

  • Study site

    North Bay, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Saint Catherines, Ontario

  • Study site

    Sarnia, Ontario

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Toronto, Ontario

  • Study site

    Trois-Rivières, Quebec

  • Study site

    Vancouver, British Columbia

  • Study site

    Waterloo, Ontario

  • Study site

    Westmount, Quebec

  • Study site

    Windsor, Ontario

Other trials in Canada

Germany9 sites

  • Study site

    Berlin

  • Study site

    Frankfurt

  • Study site

    Hamburg

  • Study site

    Herne

  • Study site

    Kiel

  • Study site

    Mahlow

  • Study site

    Mainz

  • Study site

    Regensburg

  • Study site

    Tübingen

Other trials in Germany

Russia7 sites

  • Study site

    Korolyov

  • Study site

    Moscow

  • Study site

    Novosibirsk

  • Study site

    Rostov-on-Don

  • Study site

    Saint Petersburg

  • Study site

    Saratov

  • Study site

    Yekaterinburg

Other trials in Russia

Australia6 sites

  • Study site

    Camperdown

  • Study site

    Heidelberg

  • Study site

    Maroochydore

  • Study site

    Melbourne

  • Study site

    Perth

  • Study site

    Woodville

Other trials in Australia

Hungary6 sites

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Kecskemét

  • Study site

    Szeged

  • Study site

    Szolnok

  • Study site

    Veszprém

Other trials in Hungary

Poland6 sites

  • Study site

    Bialystok

  • Study site

    Bydgoszcz

  • Study site

    Elblag

  • Study site

    Lublin

  • Study site

    Torun

  • Study site

    Warsaw

Other trials in Poland

United Kingdom6 sites

  • Study site

    Cannock

  • Study site

    Glasgow

  • Study site

    London

  • Study site

    Metropolitan Borough of Wirral

  • Study site

    Salford

  • Study site

    Wigan

Other trials in United Kingdom

Lithuania4 sites

  • Study site

    Alytus

  • Study site

    Kaunas

  • Study site

    Klaipėda

  • Study site

    Šiauliai

Other trials in Lithuania

New Zealand4 sites

  • Study site

    Auckland

  • Study site

    Christchurch

  • Study site

    Rotorua

  • Study site

    Wellington

Other trials in New Zealand

Spain4 sites

  • Study site

    Barcelona

  • Study site

    Oviedo

  • Study site

    Santiago de Compostela

  • Study site

    Seville

Other trials in Spain

Austria3 sites

  • Study site

    Graz

  • Study site

    Innsbruck

  • Study site

    Vienna

Other trials in Austria

Finland2 sites

  • Study site

    Helsinki

  • Study site

    Hyvinkää

Other trials in Finland

Latvia1 site

  • Study site

    Riga

Other trials in Latvia

About this study

Official title: 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

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.

Read the detailed description

This is a randomized (participants are assigned different treatments based on chance), double-blind (neither the participant nor the physician knows whether drug or placebo is being taken, or at what dosage), parallel-group (each group of participants will be treated at the same time), and multicenter (study conducted at multiple sites) study. Approximately, 615 participants will participate in this study. Participants will be assigned to one of three treatment groups: Group I: ustekinumab 45 mg, Group II: ustekinumab 90 mg, and Group III: placebo group (an inactive substance). Participants will receive either 45 mg ustekinumab or 90 mg ustekinumab at Weeks 0, 4, and every 12 weeks until Week 88 as randomized to respective groups. Participants in placebo group will receive placebo at Weeks 0, 4, 16, and 20 and 45 mg ustekinumab at Weeks 24 and 28 followed by every 12 weeks dosing until Week 88. Participants who do not have greater than or equal to 5 percentage improvement in their disease (tender and swollen joints) will be eligible for an early escape. Specifically, during early escape at Week 16, participants in Group I will receive 90 mg ustekinumab, for participants in Group II same dosing schedule will be continued, and participants in placebo group will receive 45 mg ustekinumab. Safety evaluations will include assessments of adverse events, clinical laboratory tests, and physical examination. The maximum study duration will be approximately 108 weeks.

Being tested
Placebo, Ustekinumab 45 mg, Ustekinumab 90 mg
Keywords
Arthritis, Psoriatic, Ustekinumab, CNTO 1275, Stelara, Psoriasis
Medical subject headings
Arthritis, Psoriatic, Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    SC injections

  • Ustekinumab 45 mgDrug

    SC injections

  • Ustekinumab 90 mgDrug

    SC injections

Study groups in NCT01009086
Study groupRoleWhat they receive
PlaceboExperimentalParticipants 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.
Receives: Drug: Placebo
Ustekinumab 45 mgExperimentalParticipants 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.
Receives: Drug: Placebo; Drug: Ustekinumab 45 mg; Drug: Ustekinumab 90 mg
Ustekinumab 90 mgExperimentalParticipants 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.
Receives: Drug: Placebo; Drug: Ustekinumab 90 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 24

Secondary outcomes (5)

  1. Change From Baseline to Week 24 in the Disability Index Score as Measured With the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI)

    The HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ-DI score which ranges from 0 (no disability) to 3 (completely disabled). In psoriatic arthritis, a decrease in score of 0.30 indicates clinically meaningful improvement.

    Measured: Day 1 (Baseline) and Week 24

  2. 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

    The PASI is a physician-administered assessment tool used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A PASI 75 response is defined as greater than or equal to 75 percent improvement in PASI score from baseline.

    Measured: Week 24

  3. Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24

    An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 50 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.

    Measured: Week 24

  4. Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24

    An ACR 70 response is defined as a greater than or equal to 70 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 70 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.

    Measured: Week 24

  5. 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

    The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, analysis for this outcome measure used pooled data from 2 studies (CNTO1275PSA3001 and PSA3002) because initial power assumptions showed that 900 participants would be required to evaluate impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens with difference to prior exposure to anti-tumor necrosis factor alpha (TNFα) therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression is provided from an integrated analysis.

    Measured: Day 1 (Baseline) and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionOct 2011
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
615 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01009086
Sponsor's protocol ID
CR016315
Other IDs
CNTO1275PSA3001, 2009-012264-14, 2009
Status last verified
Feb 2015
First submitted
5 Nov 2009
Last updated
3 Mar 2015
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 39120848

  • Helliwell 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.

    PubMed 32209721

  • Siebert 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.

    PubMed 31070869

  • Ghosh 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.

    PubMed 30739254

  • Rahman 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.

    PubMed 27483458

  • Kavanaugh 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.

    PubMed 27098404

  • Kavanaugh 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.

    PubMed 26097039

  • McInnes 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.

    PubMed 23769296

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ustekinumab 45 mg and Ustekinumab 90 mg in people with Arthritis, Psoriatic, run by Janssen Research & Development, LLC at 102 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in United States, Canada, Germany, Russia, Australia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24. (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01009086, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2015.

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