Safety Study of Abatacept to Treat Refractory Sarcoidosis

Sarcoidosis Clinical Trial

— STAR  

Official title:

Sarcoidosis, Trial of Abatacept in Refractory Disease (STAR). A Prospective Open-Label Trial of Abatacept in Progressive Sarcoidosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00739960
• Other study ID #: University of Chicago #15630B
• Status: Terminated
• Phase: Phase 2
• Start date: August 2008
• Est. completion date: December 2008

Study information

• Verified date: March 2020
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: TNFa-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

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Abatacept in Progressive Pulmonary Sarcoidosis.	Adverse events that are considered by the investigator to be reasonably or probably related to Abatacept.	24 weeks and 52 weeks
Secondary	Change From Baseline in 6-minute Walk Distance.		24 weeks and 52 weeks