A Study of Safety and Efficacy of Infliximab (Remicade) in Patients With COPD
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)
1 other identifier
interventional
234
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 chronic-obstructive-pulmonary-disease
Started Dec 2002
Typical duration for phase_3 chronic-obstructive-pulmonary-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
March 7, 2003
CompletedFirst Posted
Study publicly available on registry
March 10, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedMay 17, 2011
April 1, 2010
March 7, 2003
May 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Chronic Respiratory Questionnaire (CRQ) total score at week 24
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have moderate or severe COPD
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
Related Publications (3)
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. doi: 10.1164/rccm.200607-995OC. Epub 2007 Feb 8.
PMID: 17290043RESULTRennard SI, Flavin SK, Agarwal PK, Lo KH, Barnathan ES. Long-term safety study of infliximab in moderate-to-severe chronic obstructive pulmonary disease. Respir Med. 2013 Mar;107(3):424-32. doi: 10.1016/j.rmed.2012.11.008. Epub 2012 Dec 14.
PMID: 23246078DERIVEDLoza MJ, Watt R, Baribaud F, Barnathan ES, Rennard SI. Systemic inflammatory profile and response to anti-tumor necrosis factor therapy in chronic obstructive pulmonary disease. Respir Res. 2012 Feb 2;13(1):12. doi: 10.1186/1465-9921-13-12.
PMID: 22300528DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 7, 2003
First Posted
March 10, 2003
Study Start
December 1, 2002
Study Completion
December 1, 2004
Last Updated
May 17, 2011
Record last verified: 2010-04