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Beryllium Infliximab Study: Clinical Interventional Trial (BISCIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00111917
Recruitment Status : Terminated (Not enough patients meeting criteria to enroll in the time period)
First Posted : May 27, 2005
Results First Posted : September 25, 2014
Last Update Posted : June 2, 2016
Centocor, Inc.
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Maier, Lisa, M.D.

Brief 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.

Condition or disease Intervention/treatment Phase
Berylliosis Beryllium Disease Drug: Infliximab Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2005
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arm Intervention/treatment
Experimental: Infliximab
infusion: 3:1 infliximab:placebo ratio administered at 0, 2, 6, 12, 18 and 24 weeks.
Drug: Infliximab
Other Name: Remicade

Placebo Comparator: Placebo
infusion: 3:1 infliximab:placebo ratio administered at 0, 2, 6, 12, 18 and 24 weeks.
Other: Placebo
Placebo infusion

Primary Outcome Measures :
  1. 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 ]
    change in end-exercise A-a gradient

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00111917

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United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80401
Sponsors and Collaborators
Maier, Lisa, M.D.
Centocor, Inc.
National Center for Research Resources (NCRR)
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Principal Investigator: Lisa A Maier, MD,MSPH National Jewish Health
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Maier, Lisa, M.D. Identifier: NCT00111917    
Other Study ID Numbers: NJ202
1UL1RR025780 ( U.S. NIH Grant/Contract )
First Posted: May 27, 2005    Key Record Dates
Results First Posted: September 25, 2014
Last Update Posted: June 2, 2016
Last Verified: March 2016
Keywords provided by Maier, Lisa, M.D.:
Chronic Beryllium Disease
Beryllium Disease
Additional relevant MeSH terms:
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Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Lung Injury
Occupational Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents