A Multicenter, Observational Study of the Long-term Safety of Infliximab (REMICADE®) in Subjects with Moderate to Severe Chronic Obstructive Pulmonary disease (COPD) - RESULTS COPD

Phase 1

• Conditions: Moderate to severe COPD; MedDRA version: 8.1Level: LLTClassification code 10010952Term: COPD

• Registration Number: EUCTR2006-003431-78-NL
• Lead Sponsor: Centocor BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-01
• Study Completion: 2009-12-15
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

All consenting subjects who received at least 1 dose of study agent in either the Centocor sponsored Phase 2 clinical study (C0168T54) or in the 2 Centocor-sponsored IIS studies (EU0016 C0168X09 and EU0073 C0168X57) of infliximab in subjects with COPD.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects who are unwilling to respond to requests for long-term safety information will be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Number of subjects with each of the following safety events: malignancy or death.;Main Objective: To evaluate long-term safety information on subjects who have participated in clinical studies of infliximab in the treatment of COPD. Information will be collected on deaths and malignancies.;Secondary Objective: