Study on the Safety of Abatacept in Relapsing Polychondritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01272856|
Recruitment Status : Completed
First Posted : January 10, 2011
Last Update Posted : August 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Relapsing Polychondritis||Drug: Abatacept||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single-Center, Phase I Study on the Safety of Abatacept in Relapsing Polychondritis|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
|Experimental: Open Label Abatacept||
125 mg pre-filled syringe for sub-q injection weekly.
Other Name: Orencia
- Incidence of adverse events [ Time Frame: 24 Weeks ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272856
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|