Safety and Efficacy of Abatacept in Subjects With Chronic Urticaria Who Have Had an Inadequate Response to Anti-histamine Therapy (TAHOE)
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|ClinicalTrials.gov Identifier: NCT00886795|
Recruitment Status : Completed
First Posted : April 23, 2009
Results First Posted : January 25, 2016
Last Update Posted : January 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Urticaria||Drug: abatacept (Orencia ®)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Open-label Study to Evaluate The Safety and Efficacy of Abatacept in Subjects With Chronic Urticaria Who Have Had an Inadequate Response to Anti-histamine Therapy.|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.
Drug: abatacept (Orencia ®)
4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.
Other Name: orencia
- Number of Participants With Adverse Events [ Time Frame: baseline, 3 month and 6 months ]Participants were monitored for adverse events (AEs) at each visit. Cumulative AEs were tracked including specific AE, severity, and relationship on source documentation. Special attention was given to infusion-related events and hypersensitivity reactions. Assessment of Complete Blood Count (CBC) and Metabolic profile were also tracked.
- Number of Participants With Clinically Detectable Improvement [ Time Frame: at each visit and at 3 months ]Evaluations will occur at each visit after the first infusion. At 3 months, response will be recorded and patients with improvement will be eligible to move into the steroid and/or antihistamine tapering portion of the study. Improvement was determined by a reduction in the number of hives.
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 ClinicalTrials.gov identifier (NCT number): NCT00886795
|United States, Maryland|
|Johns Hopkins Arthritis Center|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Clifton O. Bingham, M.D.||Associate Professor of Medicine|