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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: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Sarcoidosis
 Drug: Abatacept
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by University of Chicago:

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 ]

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

Enrollment: 1
Study Start Date: August 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00739960     History of Changes
Other Study ID Numbers: IRB# 15630B
Study First Received: August 20, 2008
Last Updated: January 9, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013