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A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents

NCT01077362 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2014-02-27

Study results available
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Summary

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

Conditions

  • Arthritis, Psoriatic

Interventions

DRUG

placebo

SC injections

DRUG

ustekinumab 45 mg

SC injections

DRUG

ustekinumab 90 mg

SC injections

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-03-31
Completion
2012-11-30

Countries

  • United States
  • Austria
  • Canada
  • France
  • Germany
  • Hungary
  • Poland
  • Russia
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01077362 on ClinicalTrials.gov