Psoriasis Clinical Trial
A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis
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.
Full 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.
Eligibility Criteria
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
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
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There is 1 Location for this study
Encinitas California, , United States
La Jolla California, , United States
San Diego California, , United States
Denver Colorado, , United States
Trumbull Connecticut, , United States
Tampa Florida, , United States
Chicago Illinois, , United States
Indianapolis Indiana, , United States
New Orleans Louisiana, , United States
Wheaton Maryland, , United States
Boston Massachusetts, , United States
Fall River Massachusetts, , United States
Worcester Massachusetts, , United States
Edina Minnesota, , United States
Saint Louis Missouri, , United States
Omaha Nebraska, , United States
Freehold New Jersey, , United States
Norman Oklahoma, , United States
Tulsa Oklahoma, , United States
Portland Oregon, , United States
Duncansville Pennsylvania, , United States
Wyomissing Pennsylvania, , United States
Jackson Tennessee, , United States
Houston Texas, , United States
Webster Texas, , United States
Seattle Washington, , United States
Camperdown , , Australia
Heidelberg , , Australia
Maroochydore , , Australia
Melbourne , , Australia
Perth , , Australia
Woodville , , Australia
Graz , , Austria
Innsbruck , , Austria
Wien N/A , , Austria
Wien , , Austria
Edmonton Alberta, , Canada
Kelowna British Columbia, , Canada
Vancouver British Columbia, , Canada
Moncton New Brunswick, , Canada
St-John'S Newfoundland and Labrador, , Canada
St. John'S Newfoundland and Labrador, , Canada
Halifax Nova Scotia, , Canada
Barrie Ontario, , Canada
Hamilton Ontario, , Canada
London Ontario, , Canada
North Bay Ontario, , Canada
Sarnia Ontario, , Canada
St. Catherines Ontario, , Canada
Toronto Ontario, , Canada
Waterloo Ontario, , Canada
Windsor Ontario, , Canada
Trois-Rivieres Quebec, , Canada
Westmount Quebec, , Canada
Quebec , , Canada
Helsinki , , Finland
Hyvinkää , , Finland
Berlin , , Germany
Frankfurt , , Germany
Hamburg , , Germany
Herne , , Germany
Kiel , , Germany
Mahlow , , Germany
Mainz , , Germany
Regensburg , , Germany
Tübingen , , Germany
Budapest N/A , , Hungary
Budapest , , Hungary
Debrecen , , Hungary
Kecskemét , , Hungary
Szeged , , Hungary
Szolnok , , Hungary
Veszprém , , Hungary
Riga , , Latvia
Alytus , , Lithuania
Kaunas , , Lithuania
Klaipeda , , Lithuania
Siauliai , , Lithuania
Auckland , , New Zealand
Christchurch , , New Zealand
Rotorua , , New Zealand
Wellington , , New Zealand
Białystok , , Poland
Bydgoszcz , , Poland
Elblag , , Poland
Lublin , , Poland
Torun , , Poland
Warszawa , , Poland
Ekaterinburg , , Russian Federation
Korolev , , Russian Federation
Moscow , , Russian Federation
Novosibirsk , , Russian Federation
Rostov-On-Don , , Russian Federation
Saint Petersburg , , Russian Federation
Saratov , , Russian Federation
Barcelona , , Spain
Oviedo , , Spain
Santiago De Compostela , , Spain
Sevilla , , Spain
Cannock , , United Kingdom
Glasgow , , United Kingdom
London , , United Kingdom
Salford , , United Kingdom
Wigan , , United Kingdom
Wirral , , United Kingdom
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