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Safety Study of Abatacept to Treat Refractory Sarcoidosis (STAR)

Primary Purpose

Sarcoidosis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Abatacept
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Chicago

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Abatacept

Arm Description

Outcomes

Primary Outcome Measures

Safety of Abatacept in Progressive Pulmonary Sarcoidosis.
Adverse events that are considered by the investigator to be reasonably or probably related to Abatacept.

Secondary Outcome Measures

Change From Baseline in 6-minute Walk Distance.

Full Information

First Posted
August 20, 2008
Last Updated
March 19, 2020
Sponsor
University of Chicago
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00739960
Brief Title
Safety Study of Abatacept to Treat Refractory Sarcoidosis
Acronym
STAR
Official Title
Sarcoidosis, Trial of Abatacept in Refractory Disease (STAR). A Prospective Open-Label Trial of Abatacept in Progressive Sarcoidosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Funding has been pulled
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abatacept
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Abatacept
Other Intervention Name(s)
Orencia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety of Abatacept in Progressive Pulmonary Sarcoidosis.
Description
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 Measure Information:
Title
Change From Baseline in 6-minute Walk Distance.
Time Frame
24 weeks and 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadera J Sweiss, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety Study of Abatacept to Treat Refractory Sarcoidosis

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