Safety and Efficacy of Abatacept in Subjects With Chronic Urticaria Who Have Had an Inadequate Response to Anti-histamine Therapy (TAHOE)
|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|
|Primary Completion Date :||March 2013|
|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.
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|