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Safety and Efficacy of Abatacept in Subjects With Chronic Urticaria Who Have Had an Inadequate Response to Anti-histamine Therapy (TAHOE)

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.
ClinicalTrials.gov Identifier: NCT00886795
Recruitment Status : Completed
First Posted : April 23, 2009
Results First Posted : January 25, 2016
Last Update Posted : January 25, 2016
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Clifton O Bingham, Johns Hopkins University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Urticaria
Intervention: Drug: abatacept (Orencia ®)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Abatacept

4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.

abatacept (Orencia ®): 4 infusions of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks. The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively.


Participant Flow:   Overall Study
    Abatacept
STARTED   4 
COMPLETED   3 
NOT COMPLETED   1 
Lack of Efficacy                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
  Description
Abatacept

4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.

abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively.


Baseline Measures
   Abatacept 
Overall Participants Analyzed 
[Units: Participants]
 4 
Age 
[Units: Years]
Mean (Standard Deviation)
 43  (7.29) 
Gender 
[Units: Participants]
 
Female   2 
Male   2 
Region of Enrollment 
[Units: Participants]
 
United States   4 


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: baseline, 3 month and 6 months ]

2.  Secondary:   Number of Participants With Clinically Detectable Improvement   [ Time Frame: at each visit and at 3 months ]


  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
Open Label study. Small number of patients. Outcome measures for urticaria not standardized.


  More Information

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 more than 60 days but less than or equal to 180 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.


Results Point of Contact:  
Name/Title: Clifton O. Bingham III, M.D.
Organization: Johns Hopkins University
phone: 410-550-0578
e-mail: cbingha2@jhmi.edu



Responsible Party: Clifton O Bingham, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00886795     History of Changes
Other Study ID Numbers: Tahoe-001
First Submitted: April 22, 2009
First Posted: April 23, 2009
Results First Submitted: August 31, 2015
Results First Posted: January 25, 2016
Last Update Posted: January 25, 2016