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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.
ClinicalTrials.gov Identifier: NCT00739960
Recruitment Status : Terminated (Funding has been pulled)
First Posted : August 22, 2008
Last Update Posted : June 11, 2013
Sponsor:
Collaborator:
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
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
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis
Drug Information available for: Abatacept
U.S. FDA Resources

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

Secondary Outcome Measures :
  1. Change from baseline in 6-minute walk distance. [ Time Frame: 24 weeks aand 52 weeks ]


Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): NCT00739960


Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Bristol-Myers Squibb
Investigators
Principal Investigator: Nadera J Sweiss, MD University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00739960     History of Changes
Other Study ID Numbers: IRB# 15630B
First Posted: August 22, 2008    Key Record Dates
Last Update Posted: June 11, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents