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.

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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.

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

615

Study ID:

NCT01009086

Recruitment Status:

Completed

Sponsor:

Janssen Research & Development, LLC

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There is 1 Location for this study

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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

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

615

Study ID:

NCT01009086

Recruitment Status:

Completed

Sponsor:


Janssen Research & Development, LLC

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