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

Condition(s) targeted: Arthritis, Psoriatic

Intervention: ustekinumab (Drug); placebo (Drug); ustekinumab (Drug); ustekinumab (Drug); ustekinumab (Drug); placebo (Drug); ustekinumab (Drug); placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Centocor, Inc.

Official(s) and/or principal investigator(s):
Centocor, Inc. Clinical Trial, Study Director, Affiliation: Centocor, Inc.

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

The purpose of this study is to evaluate the efficacy (improvement of signs and symptoms) and safety of ustekinumab in patients with psoriatic arthritis.

Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Ustekinumab, a Fully Human Anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The proportion of patients with American College of Rheumatology (ACR) 20 response at Week 24.

Secondary outcome:

The proportion of patients (with baseline = 3% body surface area (BSA) psoriatic involvement) who achieve a Psoriasis Area and Severity Index 75 response at Week 24.

The change from baseline in the Physical Component Score (PCS) and the Mental Component Score (MCS) of the Short Form-36 Health Survey at Week 24.

The change from baseline in total radiographic scores of the hands and feet at Week 24.

The change from baseline in the Health Assessment Questionnaire score at Week 24.

The proportion of patients with ACR 50 and ACR 70 responses at Week 24.

Detailed description: This study is a randomized (patients are assigned different treatments based on chance), double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), parallel-group, multicenter study to evaluate the effectiveness and safety of ustekinumab compared to placebo in the treatment of patients with active psoriatic arthritis. The primary effectiveness endpoint will be measured by the reduction in signs and symptoms of arthritis, as defined by 20% improvement from baseline in American College of Rheumatology (ACR) measurements of arthritis at Week 24. The study will additionally look at higher levels of joint improvement (i. e. 50% or 70% improvement from baseline) and improvement in activity and quality of life, as well as the impact of ustekinumab on psoriatic skin lesions. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e. g., blood pressure) and the occurrence and severity of adverse events (side effects). Patients will be assigned to one of three treatment groups. Patients will receive either 45 mg ustekinumab, 90 mg ustekinumab or placebo at weeks 0, 4 and every 12 weeks until week 88. Patients who do not have >=5% improvement in their disease (tender and swollen joints) at week 16 may be eligible to receive an increase or change to their ustekinumab dosage. Ustekinumab 45 mg, 90 mg, or placebo subcutaneous injections at Weeks 0 and 4 followed by every 12 week dosing with the last dose at Week 88. Early escape possibility at Week 16. Patients randomized to placebo will crossover to receive ustekinumab at Weeks 24 and 28 followed by every 12 week dosing with the last dose at Week 88. Expected duration of exposure to study agent is 100 weeks.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 patient is using methotrexate they should have started treatment at a dose not

to exceed 25 mg/week at least 3 months prior to the beginning of the study and should have no serious toxic side effects attributable to methotrexate

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 IL-12 or IL-23, including but

not limited to ustekinumab and ABT-874

- Have used any biologic agents that are targeted for reducing TNF-alpha, including but

not limited to infliximab, etanercept, adalimumab, and golimumab

- Have a medical history of latent or active granulomatous infection, including TB,

histoplasmosis, or coccidioidomycosis, prior to screening

- 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

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

Camperdown, Australia; Completed

Heidelberg, Australia; Recruiting

Maroochydore, Australia; Recruiting

Melbourne, Australia; Recruiting

Perth, Australia; Recruiting

Woodville, Australia; Recruiting

Graz, Austria; Recruiting

Innsbruck, Austria; Recruiting

Wien, Austria; Recruiting

Wien, Austria; Not yet recruiting

Wien N/A, Austria; Recruiting

Quebec, Canada; Recruiting

Helsinki, Finland; Recruiting

Hyvinkää, Finland; Recruiting

Berlin, Germany; Recruiting

Berlin, Germany; Not yet recruiting

Frankfurt, Germany; Recruiting

Hamburg, Germany; Recruiting

Herne, Germany; Recruiting

Kiel, Germany; Not yet recruiting

Mahlow, Germany; Recruiting

Tübingen, Germany; Recruiting

Budapest, Hungary; Recruiting

Budapest N/A, Hungary; Recruiting

Debrecen, Hungary; Recruiting

Kecskemét, Hungary; Recruiting

Szeged, Hungary; Recruiting

Szolnok, Hungary; Recruiting

Riga, Latvia; Recruiting

Alytus, Lithuania; Recruiting

Kaunas, Lithuania; Recruiting

Klaipeda, Lithuania; Recruiting

Siauliai, Lithuania; Recruiting

Vilnius, Lithuania; Not yet recruiting

Auckland, New Zealand; Recruiting

Christchurch, New Zealand; Recruiting

Rotorua, New Zealand; Recruiting

Wellington, New Zealand; Recruiting

Bialystok, Poland; Recruiting

Bydgoszcz, Poland; Recruiting

Elblag, Poland; Recruiting

Lublin, Poland; Recruiting

Torun, Poland; Recruiting

Warszawa, Poland; Recruiting

Ekaterinburg, Russian Federation; Recruiting

Korolev, Russian Federation; Recruiting

Moscow, Russian Federation; Recruiting

Novosibirsk, Russian Federation; Recruiting

Rostov-On-Don, Russian Federation; Recruiting

Saint Petersburg, Russian Federation; Recruiting

Saratov, Russian Federation; Recruiting

Barcelona, Spain; Recruiting

Oviedo, Spain; Recruiting

Oviedo Asturias, Spain; Not yet recruiting

Santiago De Compostela, Spain; Recruiting

Sevilla, Spain; Recruiting

Cannock, United Kingdom; Recruiting

Glasgow, United Kingdom; Recruiting

London, United Kingdom; Active, not recruiting

Salford, United Kingdom; Not yet recruiting

Wigan, United Kingdom; Recruiting

Wirral, United Kingdom; Recruiting

Huntsville, Alabama, United States; Recruiting

Edmonton, Alberta, Canada; Recruiting

Vancouver, British Columbia, Canada; Recruiting

La Jolla, California, United States; Recruiting

Los Angeles, California, United States; Recruiting

San Diego, California, United States; Recruiting

Denver, Colorado, United States; Recruiting

Trumbull, Connecticut, United States; Recruiting

Tampa, Florida, United States; Recruiting

Chicago, Illinois, United States; Completed

Indianapolis, Indiana, United States; Recruiting

New Orleans, Louisiana, United States; Recruiting

Wheaton, Maryland, United States; Recruiting

Boston, Massachusetts, United States; Recruiting

Fall River, Massachusetts, United States; Recruiting

Worcester, Massachusetts, United States; Recruiting

Edina, Minnesota, United States; Recruiting

Saint Louis, Missouri, United States; Recruiting

Omaha, Nebraska, United States; Recruiting

Moncton, New Brunswick, Canada; Recruiting

Freehold, New Jersey, United States; Recruiting

St-John'S, Newfoundland and Labrador, Canada; Recruiting

Bismarck, North Dakota, United States; Recruiting

Halifax, Nova Scotia, Canada; Recruiting

Cleveland, Ohio, United States; Not yet recruiting

Tulsa, Oklahoma, United States; Recruiting

Barrie, Ontario, Canada; Recruiting

Hamilton, Ontario, Canada; Recruiting

London, Ontario, Canada; Recruiting

North Bay, Ontario, Canada; Recruiting

Toronto, Ontario, Canada; Recruiting

Waterloo, Ontario, Canada; Recruiting

Windsor, Ontario, Canada; Recruiting

Portland, Oregon, United States; Recruiting

Duncansville, Pennsylvania, United States; Recruiting

Wyomissing, Pennsylvania, United States; Recruiting

Westmount, Quebec, Canada; Recruiting

Jackson, Tennessee, United States; Recruiting

Houston, Texas, United States; Recruiting

Seattle, Washington, United States; Completed

To learn how to participate in this trial please click here.

Starting date: December 2009
Last updated: September 16, 2010