Safety Study of Abatacept to Treat Refractory Sarcoidosis
- Registration Number
- NCT00739960
- Lead Sponsor
- University of Chicago
- Brief Summary
The purpose of this study is to determine how safe and effective Abatacept is in treating patients who have progressive pulmonary sarcoidosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
Inclusion Criteria
- Diagnosis of sarcoidosis for at least 1 year with lung disease
- Active disease despite current treatment
- On a stable dose of sarcoidosis treatment with oral steroids, methotrexate, or hydroxychloroquine, for at least 90 days
Primary
Exclusion Criteria
- Previous treatment with Abatacept
- Currently receiving or received within the last 60 days the following: TNFα-inhibitors (infliximab, etanercept, adalimumab)
- Currently receiving or received within the last 30 days the following: cyclosporine, tacrolimus or leflunomide
- Previous treatment of IVIg within the last 6 months
- History of chronic infection that has been active within last 60 days, or herpes zoster within last 6 months, or any infection requiring hospitalization or intravenous medication within last 60 days or oral medication within the last 2 weeks
- History of congestive heart failure
- HIV
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Abatacept Abatacept -
- Primary Outcome Measures
Name Time Method Safety of Abatacept in Progressive Pulmonary Sarcoidosis. 24 weeks and 52 weeks Adverse events that are considered by the investigator to be reasonably or probably related to Abatacept.
- Secondary Outcome Measures
Name Time Method Change From Baseline in 6-minute Walk Distance. 24 weeks and 52 weeks
Trial Locations
- Locations (1)
The University of Chicago
🇺🇸Chicago, Illinois, United States