Study on the Safety of Abatacept in Relapsing Polychondritis

Relapsing Polychondritis Clinical Trial

Official title: An Open-Label, Single-Center, Phase I Study on the Safety of Abatacept in Relapsing Polychondritis

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Relapsing Polychondritis

• NCT number: NCT01272856
• Study type: Interventional
• Source: Benaroya Research Institute
• Status: Completed
• Phase: Phase 1
• Start date: January 2011
• Completion date: May 2012