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

Completed · Phase 3 · Has a placebo group

Conditions studied: Arthritis, Psoriatic

In brief

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.

Key facts

Study ID

NCT01009086

Run by

Janssen Research & Development, LLC

People needed

615

Starts

2009-12-01

Expected to finish

2013-05-01

Last updated by the study team

2015-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — La Jolla, California, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Trumbull, Connecticut, United States
• Study site — Tampa, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Wheaton, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Fall River, Massachusetts, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Edina, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Freehold, New Jersey, United States
• Study site — Norman, Oklahoma, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Portland, Oregon, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Wyomissing, Pennsylvania, United States
• Study site — Jackson, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Webster, Texas, United States
• Study site — Encinitas, California, United States

Full record on ClinicalTrials.gov

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