Trial record 1 of 3 for:    "Berylliosis"
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Beryllium Infliximab Study: Clinical Interventional Trial (BISCIT)

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by:
Maier, Lisa, M.D.
ClinicalTrials.gov Identifier:
NCT00111917
First received: May 26, 2005
Last updated: February 6, 2009
Last verified: February 2009
  Purpose

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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Maier, Lisa, M.D.:

Primary Outcome Measures:
  • arterial alveolar oxygen gradient (A-adO2) at end exercise [ Time Frame: between baseline and week 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • airflow [ Time Frame: between baseline and week 28 ] [ Designated as safety issue: No ]
  • lung volume [ Time Frame: between baseline and week 28 ] [ Designated as safety issue: No ]
  • diffusing capacity (DLCO) [ Time Frame: between baseline and week 28 ] [ Designated as safety issue: No ]
  • profusion of small opacities on chest x-ray [ Time Frame: between baseline and week 28 ] [ Designated as safety issue: No ]
  • dyspnea score [ Time Frame: between baseline and week 28 ] [ Designated as safety issue: No ]
  • quality of life (QOL) questionnaires [ Time Frame: between baseline and week 28 ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: February 2005
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults ages 18-80.
  • Noncaseating granulomas and/or mononuclear cell infiltrates demonstrated on transbronchial lung biopsy.
  • Abnormal blood and/or BAL BeLPT results.
  • Current treatment with prednisone and/or methotrexate specifically for CBD and not any other condition, at any range of dosage, for at least 6 months prior to enrollment, and on a stable dosage for at least 1 month prior to first infusion.
  • Moderate CBD severity, such that participants can safely undergo bronchoscopy with BAL including PaO2 >= 50 mmHg on room air (at Denver altitude of 5,280 ft).
  • Availability to come back to National Jewish Medical and Research Center for infusions, evaluations, and follow-ups.
  • Capable of providing informed consent.
  • Willing and able to adhere to the study visit schedule and other protocol-specified procedures.

Exclusion Criteria:

  • Positive tuberculosis (TB) skin test upon screening: An intradermal tuberculin skin test must be performed within 1 month prior to the first administration of study agent.
  • Any evidence of TB.
  • Considered ineligible according to the TB eligibility assessment, screening, and early detection of reactivation rules.
  • Positive pregnancy test.
  • Women who are pregnant, nursing, or planning pregnancy within one year after screening
  • Contraindications to bronchoscopy and BAL such as bleeding diathesis, PaO2 <50 mmHg on room air, evidence of acute infection, hemodynamic instability with labile blood pressure, either <90/60 or >160/110, untreated coronary artery disease, or other medical reason for which a subject will not be able to safely undergo bronchoscopy.
  • Positive cultures from prior BAL indicating mycobacterial or fungal infection.
  • Positive special stains for acid fast bacilli (AFB) or fungi on prior lung biopsies.
  • Known atypical mycobacterium infection.
  • Clinical evidence of active infection at time of enrollment.
  • Serious acute infections (e.g., viral hepatitis, pneumonia or pyelonephritis) in the previous 3 months.
  • Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
  • Documented HIV infection.
  • Positive serology for active hepatitis B or C. A positive result will indicate the need for referral to a consultant Hepatologist for further investigation and support.
  • Use of any investigational drug within 1 month prior to screening or within 5 half lives of the investigational agent, whichever is longer.
  • Treatment with any other therapeutic agent targeted at reducing TNF-a (e.g. pentoxifylline, thalidomide, etanercept, etc.) within 3 months of screening.
  • Prior use of Enbrel® or Humera®.
  • Previous administration of infliximab.
  • Known allergy to murine (mouse) products.
  • Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).
  • Any history of congestive heart failure, severe right sided heart failure, or cor pulmonale.
  • Presence of a transplanted organ (with the exception of a corneal transplant > 3 months prior to screening).
  • Major surgery in the previous 3 months.
  • Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
  • History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or perioaortic areas), or splenomegaly.
  • Known recent substance abuse (drug or alcohol).
  • Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111917

Locations
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80401
Sponsors and Collaborators
Maier, Lisa, M.D.
Centocor, Inc.
Investigators
Principal Investigator: Lisa A Maier, MD,MSPH National Jewish Health
  More Information

No publications provided by Maier, Lisa, M.D.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisa A. Maier, MD, MSPH, National Jewish Medical and Research Center
ClinicalTrials.gov Identifier: NCT00111917     History of Changes
Other Study ID Numbers: NJ202, HS1862
Study First Received: May 26, 2005
Last Updated: February 6, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Maier, Lisa, M.D.:
Chronic Beryllium Disease
Berylliosis
Beryllium Disease
CBD
Infliximab

Additional relevant MeSH terms:
Berylliosis
Pneumoconiosis
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Lung Injury
Occupational Diseases
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 24, 2014