Safety Study of Abatacept to Treat Refractory Sarcoidosis

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine how safe and effective Abatacept is in treating patients who have progressive pulmonary sarcoidosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: Bristol-Myers Squibb
• Treatments: Abatacept

Criteria

Primary 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