Safety Study of Abatacept to Treat Refractory Sarcoidosis (STAR)

The University of Chicago

Status and phase: Terminated; Phase 2

Conditions: Sarcoidosis

Treatments: Drug: Abatacept

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00739960

University of Chicago #15630B

Details and patient eligibility

About

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

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1 participants in 1 patient group

Abatacept

Other group

Treatment:

Drug: Abatacept