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Tracking Information | |||||
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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. |
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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. |
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Recruitment Information | |||||
Recruitment Status † | Terminated | ||||
Enrollment † | 1 | ||||
Estimated Completion Date | August 2011 | ||||
Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Primary Inclusion Criteria:
Primary Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
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 † |
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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. |