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Sponsors and Collaborators: |
Maier, Lisa, M.D. Centocor, Inc. |
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Information provided by: | Maier, Lisa, M.D. |
ClinicalTrials.gov Identifier: | NCT00111917 |
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.
Condition | Intervention | Phase |
---|---|---|
Berylliosis Beryllium Disease |
Drug: Infliximab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Efficacy Study |
Official Title: | Clinical Efficacy of Remicade in Chronic Beryllium Disease: A Randomized, Double-Blind, Placebo-Controlled, Investigator Initiated Trial |
Estimated Enrollment: | 20 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | December 2007 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa Barker, B.S. | 303-398-1723 | barkerL@njc.org |
Contact: Peggy Mroz, M.S.P.H. | 303-398-1730 | mrozp@njc.org |
United States, Colorado | |
National Jewish Medical and Research Center | Recruiting |
Denver, Colorado, United States, 80401 | |
Contact: Lisa Barker, BS 303-398-1723 barkerl@njc.org | |
Contact: Peggy Mroz, MSPH 303-398-1730 mrozp@njc.org | |
Principal Investigator: Lisa A Maier, MD, MSPH | |
Sub-Investigator: Lee S Newman, MD, MA |
Principal Investigator: | Lisa A Maier, MD,MSPH | National Jewish Health |
Study ID Numbers: | NJ202, HS1862 |
Study First Received: | May 26, 2005 |
Last Updated: | September 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00111917 |
Health Authority: | United States: Food and Drug Administration |
Chronic Beryllium Disease Berylliosis Beryllium Disease CBD Infliximab |
Berylliosis Lung Diseases, Interstitial Respiratory Tract Diseases Infliximab Chronic berylliosis |
Lung Diseases Pneumoconiosis Disorders of Environmental Origin Occupational Diseases Coal worker's pneumoconiosis |
Anti-Inflammatory Agents Therapeutic Uses Gastrointestinal Agents |
Antirheumatic Agents Dermatologic Agents Pharmacologic Actions |