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.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Berylliosis
Beryllium Disease
Interventions: Drug: Infliximab
Other: Placebo

  Participant Flow

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
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 
Withdrawal by Subject                1                1 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 9   4   13 
Age [1] 
[Units: Years]
Mean (Full Range)
 (46 to 65) 
 (67 to 74) 
 (46 to 74) 
[1] patient reported age
[Units: Participants]
Female   4   1   5 
Male   5   3   8 

  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

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

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

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Maier, Lisa, M.D. Identifier: NCT00111917     History of Changes
Other Study ID Numbers: NJ202
1UL1RR025780 ( U.S. NIH Grant/Contract )
First Submitted: May 26, 2005
First Posted: May 27, 2005
Results First Submitted: October 29, 2013
Results First Posted: September 25, 2014
Last Update Posted: June 2, 2016