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

Tracking Information

First Received Date ^ICMJE

January 14, 2003

Last Updated Date

November 26, 2008

Start Date ^ICMJE

May 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Change from baseline in total radiographic scores of hands and feet at week 24
The proportion of subjects with ACR 20 response at week 14

Change History

Complete list of historical versions of study NCT00051623 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

The number of subjects who achieved an ACR 20 response at week 24
The number of subjects who achieved PsARC at week 14
The proportion of subjects with Greater Than or Equal to 75% Improvement From Baseline in PASI at Week 14
The change from baseline in the SF-36 physical component summary scores at week 14

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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 maintanance infusions every 8 weeks until week 46. In the placebo group, paients 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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Arthritis, Psoriatic

Intervention ^ICMJE

Drug: Infliximab

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

200

Completion Date

June 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00051623

Responsible Party

Study ID Numbers ^ICMJE

CR004789

Study Sponsor ^ICMJE

Centocor, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

Information Provided By

Centocor, Inc.

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP