Safety Study of Abatacept to Treat Refractory Sarcoidosis - Full Text View

Safety Study of Abatacept to Treat Refractory Sarcoidosis (STAR)

This study is currently recruiting participants.
Verified by University of Chicago, October 2008

Sponsors and Collaborators:	University of Chicago Bristol-Myers Squibb
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00739960

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 II

MedlinePlus related topics:

Sarcoidosis

ChemIDplus related topics:

Abatacept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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

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 ]

Estimated Enrollment:	10
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Contacts


Contact: Ogarita De Loera	(773) 702-2645	odeloera@medicine.bsd.uchicago.edu

Contact: Nadera Sweiss	(773) 702-5379	nsweiss@medicine.bsd.uchicago.edu

Locations


United States, Illinois
	The University of Chicago	Recruiting
	Chicago, Illinois, United States, 60637
	Contact: Ogarita De Loera 773-702-2645 odeloera@medicine.bsd.uchicago.edu
	Principal Investigator: Nadera J Sweiss, MD

Sponsors and Collaborators

University of Chicago

Bristol-Myers Squibb

Investigators


Principal Investigator:	Nadera J Sweiss, MD	University of Chicago

More Information

Responsible Party:	The University of Chicago ( Nadera J. Sweiss, MD )
Study ID Numbers:	IRB# 15630B
First Received:	August 20, 2008
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00739960
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lymphatic Diseases

Abatacept

Sarcoidosis

Lymphoproliferative Disorders

Additional relevant MeSH terms:

Immunologic Factors

Therapeutic Uses

Physiological Effects of Drugs

Antirheumatic Agents

Immunosuppressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008