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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01009086




Registration number
NCT01009086
Ethics application status
Date submitted
5/11/2009
Date registered
6/11/2009
Date last updated
3/03/2015

Titles & IDs
Public title
A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis
Scientific 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
Secondary ID [1] 0 0
CNTO1275PSA3001
Secondary ID [2] 0 0
CR016315
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Psoriatic 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Ustekinumab 45 mg
Treatment: Drugs - Ustekinumab 90 mg

Experimental: Placebo - Participants 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.

Experimental: Ustekinumab 45 mg - Participants 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.

Experimental: Ustekinumab 90 mg - Participants 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.


Treatment: Drugs: Placebo
SC injections

Treatment: Drugs: Ustekinumab 45 mg
SC injections

Treatment: Drugs: Ustekinumab 90 mg
SC injections

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 1 (Baseline) and Week 24
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
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 (TNFa) 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.
Timepoint [5] 0 0
Day 1 (Baseline) and Week 24

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Heidelberg
Recruitment hospital [3] 0 0
- Maroochydore
Recruitment hospital [4] 0 0
- Melbourne
Recruitment hospital [5] 0 0
- Perth
Recruitment hospital [6] 0 0
- Woodville
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Heidelberg
Recruitment postcode(s) [3] 0 0
- Maroochydore
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment postcode(s) [6] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
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Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
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Louisiana
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United States of America
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Maryland
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Massachusetts
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Minnesota
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Missouri
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Nebraska
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New Jersey
Country [14] 0 0
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Oklahoma
Country [15] 0 0
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Washington
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Wien N/A
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Austria
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Wien
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Canada
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Alberta
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British Columbia
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New Brunswick
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Newfoundland and Labrador
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Nova Scotia
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Ontario
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Canada
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Quebec
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Finland
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Helsinki
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Finland
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Hyvinkää
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Hamburg
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Herne
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Kiel
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Mahlow
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Mainz
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Regensburg
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Germany
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Tübingen
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Hungary
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Budapest N/A
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Budapest
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Debrecen
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Kecskemét
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Szeged
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Szolnok
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Riga
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Lithuania
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Alytus
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Kaunas
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Auckland
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Christchurch
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Rotorua
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Wellington
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Torun
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Russian Federation
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Ekaterinburg
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Korolev
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Moscow
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Novosibirsk
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Rostov-On-Don
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Spain
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Sevilla
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United Kingdom
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Cannock
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Glasgow
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London
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Salford
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Wigan
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United Kingdom
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Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT01009086
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications