Study Stopped
Funding has been pulled
Safety Study of Abatacept to Treat Refractory Sarcoidosis
STAR
Sarcoidosis, Trial of Abatacept in Refractory Disease (STAR). A Prospective Open-Label Trial of Abatacept in Progressive Sarcoidosis
1 other identifier
interventional
1
1 country
1
Brief Summary
The purpose of this study is to determine how safe and effective Abatacept is in treating patients who have progressive pulmonary sarcoidosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 20, 2008
CompletedFirst Posted
Study publicly available on registry
August 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
March 17, 2020
CompletedMarch 23, 2020
March 1, 2020
4 months
August 20, 2008
November 19, 2015
March 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change From Baseline in 6-minute Walk Distance.
24 weeks and 52 weeks
Study Arms (1)
Abatacept
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Chicagolead
- Bristol-Myers Squibbcollaborator
Study Sites (1)
The University of Chicago
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nadera J Sweiss, MD
- Organization
- UIC
Study Officials
- PRINCIPAL INVESTIGATOR
Nadera J Sweiss, MD
University of Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2008
First Posted
August 22, 2008
Study Start
August 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
March 23, 2020
Results First Posted
March 17, 2020
Record last verified: 2020-03