Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT01272856
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 Description:
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.
Study:
NCT01272856
Study Brief:
Protocol Section:
NCT01272856