A Study of the Safety and Effectiveness of Infliximab for the Treatment of Psoriatic Arthritis

May 16, 2011 updated by: Centocor, Inc.

A Multicenter, Randomized, Double-blind Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) for the Treatment of Patients With Psoriatic Arthritis

The purpose of this study is to determine if Infliximab is safe and effective in the treatment of psoriatic arthritis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a phase III, multicenter, 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), placebo-controlled study designed to determine the safety and effectiveness of Infliximab in the treatment of patients with psoriatic arthritis. This is an experimental medical research study. A total of 200 people in North America and Europe participated in this study during the 17 month study period. Patients will receive infusions of either placebo or 5 or 10 mg/kg infliximab (Remicade) at weeks 0,2, 6, 14, 16, 18, 22, 30, 38, and 46. Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive either placebo or 5 mg/kg induction infusions (weeks 0, 2 and 6) followed by maintenance infusions every 8 weeks until week 46. In the placebo group, patients may early escape at week 16 and crossover at week 24 to infliximab;. In the 5mg/kg group, dose escalation if needed at week 38.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed psoriatic arthritis for >= 6 months
  • active arthritis with >= 5 tender and 5 swollen joints
  • active psoriasis

Exclusion Criteria:

  • Have other inflammatory diseases, including but not limited to, rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease
  • Received any systemic immunosuppressives within 4 weeks prior to enrollment in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The proportion of patients with American College of Rheumatology (ACR) 20 response at week 14 Change from baseline in total radiographic scores of hands and feet at week 24

Secondary Outcome Measures

Outcome Measure
Number of patients who achieved an ACR 20 response at wk 24; PsARC at wk 14; proportion of patients with >= to 75% Improvement From Baseline in PASI at Week 14; change from baseline SF 36 physical component summary scores at wk 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centocor, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

January 14, 2003

First Submitted That Met QC Criteria

January 14, 2003

First Posted (Estimate)

January 15, 2003

Study Record Updates

Last Update Posted (Estimate)

May 17, 2011

Last Update Submitted That Met QC Criteria

May 16, 2011

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR004789

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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