Safety Study of Abatacept to Treat Refractory Sarcoidosis - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 20, 2008

Last Updated Date

December 22, 2008

Start Date ^†

August 2008

Current Primary Outcome Measures ^†

Adverse events that are considered by the investigator to be reasonably or probably related to Abatacept. [ Time Frame: 24 weeks and 52 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00739960 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Change from baseline in 6-minute walk distance. [ Time Frame: 24 weeks aand 52 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Safety Study of Abatacept to Treat Refractory Sarcoidosis

Official Title ^†

Sarcoidosis, Trial of Abatacept in Refractory Disease (STAR). A Prospective Open-Label Trial of Abatacept in Progressive Sarcoidosis

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

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Sarcoidosis

Intervention ^†

Drug: Abatacept

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Enrollment ^†

Estimated Completion Date

August 2011

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00739960

Responsible Party

Nadera J. Sweiss, MD, The University of Chicago

Secondary IDs ^††

Study Sponsor ^†

University of Chicago

Collaborators ^††

Bristol-Myers Squibb

Investigators ^†

Principal Investigator:

Nadera J Sweiss, MD

University of Chicago

Information Provided By

University of Chicago

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.