Study on the Safety of Abatacept in Relapsing Polychondritis
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open-Label, Single-Center, Phase I Study on the Safety of Abatacept in Relapsing Polychondritis|
- Incidence of adverse events [ Time Frame: 24 Weeks ]
- Physician assessment of chondritis burden [ Time Frame: 24 Weeks ]
- Acute phase reactants (ESR, CRP) [ Time Frame: 24 weeks ]
- Patient and physician-reported outcome measures, including HAQ, SF-36, and Visual Analogue Scores [ Time Frame: 24 weeks ]
|Study Start Date:||January 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|Experimental: Open Label Abatacept||
125 mg pre-filled syringe for sub-q injection weekly.
Other Name: Orencia
After a screening period of up to 4 weeks, patients who fulfill all inclusion and exclusion criteria will receive open-label subcutaneous abatacept consisting of 125 mg weekly, beginning 1 week thru Week 24.
Throughout the study, blood will be collected for clinical laboratory safety, pharmacodynamics and biomarkers. Disease activity assessments will include laboratory evaluation of acute phase reactants, pulmonary function testing, computed tomography of the neck and chest, electrocardiogram, echocardiogram, audiogram, physician assessment of chondritis activity, swollen and tender joint counts, and patient- and physican-reported outcomes. Adverse events and concomitant medications will be recorded.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272856
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|