Beryllium Infliximab Study: Clinical Interventional Trial (BISCIT)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Clinical Efficacy of Remicade in Chronic Beryllium Disease: A Randomized, Double-Blind, Placebo-Controlled, Investigator Initiated Trial|
- A-a Gradient at End Exercise [ Time Frame: after 28 week follow-up. The Alveolar-arterial gradient (A-a gradient), is a measure of the difference between the alveolar partial pressure (A) of oxygen and the arterial (a) partial pressure of oxygen ] [ Designated as safety issue: No ]change in end-exercise A-a gradient
|Study Start Date:||February 2005|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
infusion: 3:1 infliximab:placebo ratio administered at 0, 2, 6, 12, 18 and 24weeks.
Other Name: Remicade
Placebo Comparator: placebo
infusion 3:1 infliximab:placebo ratio administered at 0, 2, 6, 12, 18 and 24weeks.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00111917
|United States, Colorado|
|National Jewish Health|
|Denver, Colorado, United States, 80401|
|Principal Investigator:||Lisa A Maier, MD,MSPH||National Jewish Health|