MedTrace Logo

A Study to Evaluate the Safety and Effectiveness of CNTO 888 Administered Intravenously (IV) in Participants With Idiopathic Pulmonary Fibrosis (IPF)

NCT00786201 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2015-12-28

No results posted yet for this study

Summary

The experimental drug CNTO 888 is currently being studied in cancer patients with solid tumors and this study is the first to use this drug for patients with idiopathic pulmonary fibrosis (IPF). This study tests the safety and effectiveness of CNTO 888 compared to placebo. The purpose of this research study is to determine if CNTO 888 is safe and to determine its effects (good and bad) on patients with IPF. The study will be conducted at approximately 28 sites globally. Patients can remain on usual, accepted treatment for IPF while enrolled in the study. Participating in other experimental studies or taking other experimental medications while participating in this study will not be allowed.

Conditions

Interventions

DRUG

Placebo

Intravenous (IV) infusion every 4 weeks, from Week 0 through Week 48

DRUG

CNTO 888 1 mg/kg

IV infusion every 4 weeks, from Week 0 through Week 48

DRUG

CNTO 888 5 mg/kg

IV infusion every 4 weeks, from Week 0 through Week 48

DRUG

CNTO 888 15 mg/kg

IV infusion every 4 weeks, from Week 0 through Week 48

Sponsors & Collaborators

  • Centocor, Inc.

    lead INDUSTRY

Principal Investigators

  • Centocor, Inc. Clinical Trial · Centocor, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00786201 on ClinicalTrials.gov