Clinical Trial: Study on the Safety of Abatacept in Relapsing Polychondritis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-Label, Single-Center, Phase I Study on the Safety of Abatacept in Relapsing Polychondritis
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: Benaroya Research Institute
Current Primary Outcome: Incidence of adverse events [ Time Frame: 24 Weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Benaroya Research Institute
Dates:
Date Received: January 6, 2011
Date Started: January 2011
Date Completion:
Last Updated: August 3, 2012
Last Verified: August 2012
