Safety Study of Abatacept to Treat Refractory Sarcoidosis

NCT ID: NCT00739960

Last Updated: 2020-03-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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Conditions

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Sarcoidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Abatacept

Group Type OTHER

Abatacept

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Orencia

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nadera J Sweiss, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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University of Chicago #15630B

Identifier Type: -

Identifier Source: org_study_id

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