Safety Study of Abatacept to Treat Refractory Sarcoidosis
Information source: University of Chicago
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sarcoidosis
Intervention: Abatacept (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: University of Chicago Official(s) and/or principal investigator(s): Nadera J Sweiss, MD, Principal Investigator, Affiliation: University of Chicago
Summary
The purpose of this study is to determine how safe and effective Abatacept is in treating
patients who have progressive pulmonary sarcoidosis.
Clinical Details
Official title: Sarcoidosis, Trial of Abatacept in Refractory Disease (STAR). A Prospective Open-Label Trial of Abatacept in Progressive Sarcoidosis
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Adverse events that are considered by the investigator to be reasonably or probably related to Abatacept.
Secondary outcome: Change from baseline in 6-minute walk distance.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
The University of Chicago, Chicago, Illinois 60637, United States
Additional Information
Starting date: August 2008
Last updated: June 10, 2013
|