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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003431-78-NL

Enrollment

269

Registered

2006-09-01

Start date

2006-10-24

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe COPD MedDRA version: 8.1 Level: LLT Classification code 10010952 Term: COPD

Interventions

Trade Name: Remicade Product Name: infliximab Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277313 Concentration unit: mg milligram(s) Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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:	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026