Study on the Safety of Abatacept in Relapsing Polychondritis
The purpose of this study is to test the safety of the study drug abatacept and see what effects (good and bad) it has in patients with relapsing polychondritis.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
- Physician assessment of chondritis burden [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
- Acute phase reactants (ESR, CRP) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Patient and physician-reported outcome measures, including HAQ, SF-36, and Visual Analogue Scores [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
|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.