A Study of Safety and Efficacy of Infliximab (Remicade) in Patients With COPD - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 7, 2003

Last Updated Date

March 28, 2008

Start Date ^†

December 2002

Current Primary Outcome Measures ^†

Change from baseline in Chronic Respiratory Questionnaire (CRQ) total score at week 24

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00056264 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Change in pre-bronchodilator predicted forced expiratory volume in 1 second (FEV1) at week 24 , in 6-minute walk distance at week 24, in health survey (SF-36) physical component summary score at week 24, in Transition Dyspnea Index (TDI) score at week 24

Original Secondary Outcome Measures ^†

Change from baseline in pre-bronchodilator percent predicted forced expiratory volume in 1 second (FEV1) at week 24
Change from baseline in the 6-minute walk distance at week 24
Change from baseline in the 36-item short form health survey (SF-36) physical component summary score at week 24
Change from baseline in the Transition Dyspnea Index (TDI) score at week 24
Incidence of moderate to severe COPD exacerbations through week 24

Descriptive Information

Brief Title ^†

A Study of Safety and Efficacy of Infliximab (Remicade) in Patients With COPD

Official Title ^†

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group, Dose Finding Study Evaluating the Safety and Efficacy of Infliximab Administration in Symptomatic Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of infliximab (Remicade) in patients with Chronic Obstructive Pulmonary Disease (COPD). 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

Chronic Obstructive Pulmonary Disease (COPD) is a smoking-related inflammatory lung disease that results in reduced lung function, causing the symptoms or problems that you have when breathing. COPD includes both chronic bronchitis and emphysema. The symptoms of COPD are cough, sputum (phlegm) production, breathlessness, and wheezing. Advanced disease may also involve changes in appetite and weight loss. The drug used in this study is called Remicadeâ, and the active component is called infliximab. Infliximab binds to and blocks the activity of a naturally occurring substance in the body called tumor necrosis factor alpha or TNFa, which may be associated with inflammation and a decrease in lung function.The purpose of this study is to evaluate the safety and effectiveness of infliximab in the treatment of patients with symptoms of moderate to severe COPD.Patients will be receive infusions of either placebo, 3 mg/kg infliximab or 5mg/kg infliximab at weeks 0, 2, 6, 12, 18, and 24.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 infusions of either placebo, 3 mg/kg infliximab or 5mg/kg infliximab at weeks 0, 2, 6, 12, 18, and 24.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

COPD
Chronic Obstructive Pulmonary Disease

Intervention ^†

Drug: Infliximab

Study Arms / Comparison Groups

Publications *

Rennard SI, Fogarty C, Kelsen S, Long W, Ramsdell J, Allison J, Mahler D, Saadeh C, Siler T, Snell P, Korenblat P, Smith W, Kaye M, Mandel M, Andrews C, Prabhu R, Donohue JF, Watt R, Lo KH, Schlenker-Herceg R, Barnathan ES, Murray J; COPD Investigators. The safety and efficacy of infliximab in moderate to severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2007 May 1;175(9):926-34. Epub 2007 Feb 8.

* 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 ^†

Completed

Enrollment ^†

225

Completion Date

December 2004

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Patients must have moderate or severe COPD
Patients must have at least one episode of COPD-related symptoms (eg, cough, sputum production, shortness of breath) within 2 months prior to screening

Exclusion Criteria:

Patients must not have asthma as main component of obstructive airway disease
Patients must not have had a moderate or severe exacerbation of COPD within previous 1 month

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00056264

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Centocor, Inc.

Collaborators ^††

Investigators ^†

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

Information Provided By

Centocor, Inc.

Verification Date

March 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.