Understanding the Relationship Between Infliximab Levels to Clinical Response of Remicade in Crohn's Disease

This study has been terminated.
(terminated due to poor enrollment)
Sponsor:
Collaborator:
Prometheus Laboratories
Information provided by (Responsible Party):
Shradha Agarwal, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01438151
First received: September 20, 2011
Last updated: March 4, 2014
Last verified: March 2014
Results First Received: January 6, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Crohn's Disease
Intervention: Drug: Remicade

  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
11 patients were recruited between 2/16/12 and 10/18/12. Patient were recruited either during inpatient hospitalization or outpatient visit for Remicade.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Remicade

If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.

Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.


Participant Flow:   Overall Study
    Remicade  
STARTED     11  
COMPLETED     3  
NOT COMPLETED     8  
study terminated                 8  



  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
Remicade

If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.

Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.


Baseline Measures
    Remicade  
Number of Participants  
[units: participants]
  11  
Age  
[units: years]
Mean ( Full Range )
  34  
  ( 10 to 55 )  
Gender  
[units: participants]
 
Female     5  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     11  



  Outcome Measures

1.  Primary:   Remicade Dose Escalation   [ Time Frame: 2/16/12-3/22/13 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
Study was terminated without completion due to poor enrollment.  


Results Point of Contact:  
Name/Title: Dr. Shradha Agarwal
Organization: Mount Sinai
phone: 212-659-9261
e-mail: shradha.agarwal@mssm.edu


No publications provided


Responsible Party: Shradha Agarwal, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01438151     History of Changes
Other Study ID Numbers: 11-0693
Study First Received: September 20, 2011
Results First Received: January 6, 2014
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration