- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00267956
An Effectiveness and Safety Study of CNTO 1275 in Patients With Active Psoriatic Arthritis
May 30, 2013 updated by: Centocor, Inc.
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of CNTO 1275, a Fully Human Anti-IL-12 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis
The purpose of this study is to evaluate the effectiveness and safety of CNTO 1275 (ustekinumab) in patients with psoriatic arthritis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is a randomized (the study drug is assigned by chance), double-blind (neither physician nor the patient knows the treatment that the patient receives), parallel-group (each group of patients will be treated at the same time), multicenter study to evaluate the effectiveness and safety of CNTO 1275 compared to placebo in the treatment of patients with active psoriatic arthritis.
Patients will be randomized in 1:1 ratio to 1 of 2 treatment groups (CNTO 1275 63 mg and placebo).
Patients will be randomly assigned to receive study medication up to Week 12 and will be followed through Week 36 to monitor safety and efficacy.
Patients randomly assigned to placebo will crossover to receive CNTO 1275 63 mg at Weeks 12 and 16.
Patients randomly assigned to CNTO 1275 will receive placebo at Weeks 12 and 16 to maintain the blind.
The duration of participation for an individual patient in the study will be up to 36 weeks.
Study Type
Interventional
Enrollment (Actual)
146
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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British Columbia
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Surrey, British Columbia, Canada
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Ontario
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Barrie, Ontario, Canada
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Hamilton, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Aarhus C, Denmark
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Hellerup N/A, Denmark
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København Nv, Denmark
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Hus, Finland
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Tampere, Finland
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Genève, Switzerland
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Georgia
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Macon, Georgia, United States
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Idaho
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Boise, Idaho, United States
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Illinois
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Normal, Illinois, United States
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Indiana
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Indianapolis, Indiana, United States
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Louisiana
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Covington, Louisiana, United States
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Massachusetts
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Boston, Massachusetts, United States
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Michigan
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Ann Arbor, Michigan, United States
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Nevada
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Las Vegas, Nevada, United States
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New Jersey
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New Brunswick, New Jersey, United States
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New York
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New York, New York, United States
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North Carolina
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Wilmington, North Carolina, United States
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Utah
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Salt Lake City, Utah, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have had active psoriatic arthritis for at least 6 months prior to administration of first study injection
- Have an active plaque psoriasis (defined as a lesion of at least 2 cm in diameter), but not in armpits, on chest between breasts or groin
- Women of childbearing potential and all men must be using an effective method of birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must agree to continue to use such measures until 12 months after receiving the last injection of study agent
- Have an active arthritis despite disease-modifying anti-rheumatic drugs (DMARD) such as leflunomide, gold, sulfasalazine, but not including methotrexate) or non-steroidal anti-inflammatory agents (NSAID) such as aspirin, ibuprofen, naproxen) therapy. DMARD therapy is defined as taking a DMARD for at least 3 months, or evidence of not tolerating DMARD. NSAID therapy is defined as taking an NSAID for at least 4 weeks
- If the patients are using methotrexate (MTX), they should have started treatment at least 3 months prior to the first administration of study agent and should have no serious toxic side effects attributable to MTX
- Have no signs or symptoms suggestive of active tuberculosis upon medical history, physical examination and chest X-ray
Exclusion Criteria:
- Have received DMARDs, other than methotrexate, within 4 weeks prior to the randomization visit
- Have used any biologic within the previous 3 months or 5 times the half-life of the biologic, whichever is longer
- Have received any oral, intravenous or intramuscular medications/treatments that could affect psoriasis (including, but not limited to, oral or injectable corticosteroids, retinoids, 1,25 dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine, hydroxyurea, fumaric acid derivatives, or phototherapy) within 4 weeks of the randomization visit and/or have used topical medications/treatments that could affect psoriasis (eg, corticosteroids, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens) within 2 weeks of the randomization visit
- Have a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), or open, draining, or infected skin wounds or ulcers
- Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis, prior to screening
- Have current signs or symptoms of severe, progressive, or uncontrolled kidney, liver, blood, intestinal, hormonal, lung, heart, nervous, brain, or psychiatric disease
- Have any known cancer or have a history of cancer within the previous 5 years (with the following exception: have had basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated, with no evidence of recurrence)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CNTO1275 (ustekinumab)
Group 1: Patients will receive CNTO 1275 63 mg at Weeks 0, 1, 2, and 3.
At Weeks 12 and 16, patients will receive placebo to maintain the blind.
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The patients will receive 90 mg (or 63 mg after filtration) subcutaneous injection on Weeks 0, 1, 2, and 3; Placebo subcutaneous injection on Weeks 12 and 16.
The patients will receive placebo subcutaneous injection on Weeks 0, 1, 2, and 3; At weeks 12 and 16 the patients will receive CNTo1275 90 mg (or 63 mg after filtration) subcutaneous injection
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Placebo Comparator: Placebo
Group 2: Patients will receive placebo at Weeks 0, 1, 2, and 3.
At Weeks 12 and 16, patients will receive CNTO 1275 63 mg.
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The patients will receive 90 mg (or 63 mg after filtration) subcutaneous injection on Weeks 0, 1, 2, and 3; Placebo subcutaneous injection on Weeks 12 and 16.
The patients will receive placebo subcutaneous injection on Weeks 0, 1, 2, and 3; At weeks 12 and 16 the patients will receive CNTo1275 90 mg (or 63 mg after filtration) subcutaneous injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12
Time Frame: Week 0 to Week 12
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ACR 20 response is an improvement of greater than or equal to 20 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).
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Week 0 to Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12
Time Frame: Week 12
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ACR 50 response is an improvement of greater than or equal to 50 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).
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Week 12
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Number of Participants With an American College of Rheumatology (ACR) 70 Response at Week 12
Time Frame: Week 12
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ACR 70 response is an improvement of greater than or equal to 70 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).
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Week 12
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Change in Health Assessment Questionnaire (HAQ) at Week 12
Time Frame: Week 0 to Week 12
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The HAQ is a 20-question instrument 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, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task.
The HAQ score is determined by the average of the 8 scores.
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Week 0 to Week 12
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Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent at Week 12
Time Frame: Week 12
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Number of participants achieving greater than or equal to 75 perccentage mprovement PASI at Week 12. PASI is widely used tool for the measurement of severity of psoriasis.
This is a test of how bad person's psoriasis is.
The combine redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
The scale ranges from 0 (best) to 72 (worst).
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Week 12
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Change in Dermatology Life Quality Index (DLQI) at Week 12
Time Frame: Week 0 to Week 12
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Change in Dermatology Life Quality Index (DLQI) from baseline at Week 12.
The DLQI is a 10 item questionnaire, is designed to assess the impact of the disease on a participant's quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment.
The score ranges from 0 (better quality of life) to 30 (worse quality of life).
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Week 0 to Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Drug Saf. 2019 Apr 22;:
- Gottlieb A, Menter A, Mendelsohn A, Shen YK, Li S, Guzzo C, Fretzin S, Kunynetz R, Kavanaugh A. Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial. Lancet. 2009 Feb 21;373(9664):633-40. doi: 10.1016/S0140-6736(09)60140-9. Epub 2009 Feb 11. Erratum In: Lancet. 2009 Apr 18;373(9672):1340. Lancet. 2010 Nov 6;376(9752):1542.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
March 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
December 20, 2005
First Submitted That Met QC Criteria
December 20, 2005
First Posted (Estimate)
December 22, 2005
Study Record Updates
Last Update Posted (Estimate)
June 5, 2013
Last Update Submitted That Met QC Criteria
May 30, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR006322
- C0743T10 (Other Identifier: Centocor)
- 2005-003525-92 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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