Safety Study of Abatacept to Treat Refractory Sarcoidosis

Phase 2TerminatedNCT00739960

University of Chicago1 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sarcoidosis

Interventions

AbataceptDRUG

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Safety of Abatacept in Progressive Pulmonary Sarcoidosis.

Adverse events that are considered by the investigator to be reasonably or probably related to Abatacept.

Time frame: 24 weeks and 52 weeks

Secondary Outcomes

Change From Baseline in 6-minute Walk Distance.

Time frame: 24 weeks and 52 weeks

Data from ClinicalTrials.gov

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