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Beryllium Infliximab Study: Clinical Interventional Trial (BISCIT)

This study has been terminated.
(Not enough patients meeting criteria to enroll in the time period)
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Maier, Lisa, M.D.
ClinicalTrials.gov Identifier:
NCT00111917
First received: May 26, 2005
Last updated: September 24, 2014
Last verified: September 2014
Results First Received: October 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Berylliosis
Beryllium Disease
Intervention: Drug: Infliximab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We aimed to enroll 20 CBD subjects on stable doses of corticosteroids and/or methotrexate, with no evidence of active or chronic infection, malignancy, other chronic disease, or past treatment with another biologic with a 3:1 infliximab:placebo ratio

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
the sponsor stopped the study due to slow recruitment

Reporting Groups
  Description
Group 1 - Infliximab This group was given an infusion of inliximab
Group 2 - Placebo This group was given a placebo infusion

Participant Flow:   Overall Study
    Group 1 - Infliximab     Group 2 - Placebo  
STARTED     9     4  
COMPLETED     8     3  
NOT COMPLETED     1     1  
Withdrawal by Subject                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Infliximab patients who will be placed on infliximab and controls who will get placebo
Control CBD placed on placebo
Total Total of all reporting groups

Baseline Measures
    Infliximab     Control     Total  
Number of Participants  
[units: participants]
  9     4     13  
Age [1]
[units: years]
Mean ( Full Range )
  54.63  
  ( 46 to 65 )  
  69.75  
  ( 67 to 74 )  
  56.5  
  ( 46 to 74 )  
Gender  
[units: participants]
     
Female     4     1     5  
Male     5     3     8  
[1] patient reported age



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Post-Hoc:   Absolute Numbers of Lymphocytes   [ Time Frame: after 28 week follow-up ]

3.  Post-Hoc:   BAL WBC/cc   [ Time Frame: after 28 weeks ]

4.  Post-Hoc:   BAL % Lymphocytes   [ Time Frame: after 28 week infusion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Although our goal was 20 CBD subjects, only 11 subjects were enrolled, 8:3 in the infliximab:placebo treatment arms as the study was stopped by the sponsor due to slow recruitment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lisa Maier, MD
Organization: National Jewish Health
phone: 303-398-1983
e-mail: maierl@njhealth.org


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

Publications automatically indexed to this study:

Responsible Party: Maier, Lisa, M.D.
ClinicalTrials.gov Identifier: NCT00111917     History of Changes
Other Study ID Numbers: NJ202, 1UL1RR025780
Study First Received: May 26, 2005
Results First Received: October 29, 2013
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration