Relapsing Polychondritis Clinical Trial
Official title:
An Open-Label, Single-Center, Phase I 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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02257866 -
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
|
||
Completed |
NCT04077736 -
Low-dose Recombinant Human IL-2 for the Treatment of Relapsing Polychondritis
|
Phase 2 | |
Withdrawn |
NCT01104480 -
Tocilizumab for Relapsing Polychondritis
|
Phase 2 | |
Active, not recruiting |
NCT05168475 -
Biologics in Refractory Vasculitis
|
Phase 2 | |
Completed |
NCT01041248 -
Single Patient Study to Treat Relapsing Polychondritis With Tocilizumab
|
N/A | |
Recruiting |
NCT04919538 -
Longitudinal Study for Relapsing Polychondritis
|
||
Recruiting |
NCT06019221 -
Pediatric Relapsing Polychondritis : Diagnosis and Management in a French Retrospective Study
|
||
Recruiting |
NCT03840928 -
PatientSpot Formerly Known as ArthritisPower
|