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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

Page last updated: August 23, 2015

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