NCT01272856

Study on the Safety of Abatacept in Relapsing Polychondritis

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Benaroya Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsing Polychondritis

Interventions

Type	Name	Description
DRUG	Abatacept	125 mg pre-filled syringe for sub-q injection weekly.

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-01-10
• Last updated: 2012-08-07

Locations

1 site across 1 country: United States