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Beryllium Infliximab Study: Clinical Interventional Trial

NCT00111917 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2016-06-02

Study results available
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Summary

The goal of this research study is to test the clinical effectiveness of a drug called infliximab (Remicade) in chronic beryllium disease (CBD). This drug may reduce tumor necrosis factor-alpha (TNF-a), which is associated with more severe disease and inflammation in the lung. Receiving infliximab may help with symptoms, and may improve clinical testing data normally ordered by your doctor, such as breathing tests. Baseline and follow-up testing will look for improvements in breathing tests (pulmonary function testing), exchange of oxygen in the lungs (exercise test), chest x ray, and lung inflammation.

Conditions

  • Berylliosis
  • Beryllium Disease

Interventions

DRUG

Infliximab

anti-TNF

OTHER

Placebo

Placebo infusion

Sponsors & Collaborators

  • Centocor, Inc.

    collaborator INDUSTRY

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Maier, Lisa, M.D.

    lead INDIV

Principal Investigators

  • Lisa A Maier, MD,MSPH · National Jewish Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00111917 on ClinicalTrials.gov