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Safety Study of Abatacept to Treat Refractory Sarcoidosis (STAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00739960
Recruitment Status : Terminated (Funding has been pulled)
First Posted : August 22, 2008
Results First Posted : March 17, 2020
Last Update Posted : March 23, 2020
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
The purpose of this study is to determine how safe and effective Abatacept is in treating patients who have progressive pulmonary sarcoidosis.

Condition or disease Intervention/treatment Phase
Sarcoidosis Drug: Abatacept Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sarcoidosis, Trial of Abatacept in Refractory Disease (STAR). A Prospective Open-Label Trial of Abatacept in Progressive Sarcoidosis
Study Start Date : August 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis
Drug Information available for: Abatacept

Arm Intervention/treatment
Abatacept 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

Primary Outcome Measures :
  1. Safety of Abatacept in Progressive Pulmonary Sarcoidosis. [ Time Frame: 24 weeks and 52 weeks ]
    Adverse events that are considered by the investigator to be reasonably or probably related to Abatacept.

Secondary Outcome Measures :
  1. Change From Baseline in 6-minute Walk Distance. [ Time Frame: 24 weeks and 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00739960

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United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Bristol-Myers Squibb
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Principal Investigator: Nadera J Sweiss, MD University of Chicago
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Responsible Party: University of Chicago Identifier: NCT00739960    
Other Study ID Numbers: University of Chicago #15630B
First Posted: August 22, 2008    Key Record Dates
Results First Posted: March 17, 2020
Last Update Posted: March 23, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Lymphoproliferative Disorders
Lymphatic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents