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Safety Study of Abatacept to Treat Refractory Sarcoidosis (STAR)

This study has been terminated.
(Funding has been pulled)
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00739960
First received: August 20, 2008
Last updated: June 10, 2013
Last verified: June 2013
History of Changes

August 20, 2008
June 10, 2013
August 2008
December 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00739960 on ClinicalTrials.gov Archive Site
Change from baseline in 6-minute walk distance. [ Time Frame: 24 weeks aand 52 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety Study of Abatacept to Treat Refractory Sarcoidosis
Sarcoidosis, Trial of Abatacept in Refractory Disease (STAR). A Prospective Open-Label Trial of Abatacept in Progressive Sarcoidosis

The purpose of this study is to determine how safe and effective Abatacept is in treating patients who have progressive pulmonary sarcoidosis.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sarcoidosis
Drug: Abatacept
10mg/kg IV (infusion directly into the vein of the arm) Day 1, week 2, week 4 and then every 4 week for 44 weeks.
Other Name: Orencia
Abatacept
Intervention: Drug: Abatacept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00739960
IRB# 15630B
Yes
University of Chicago
University of Chicago
Bristol-Myers Squibb
Principal Investigator: Nadera J Sweiss, MD University of Chicago
University of Chicago
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP