A Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept

Astellas Pharma Inc26 enrolled

Overview

The purpose of this study is to characterize CD86 receptor occupancy in subjects with rheumatoid arthritis (RA) receiving abatacept.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

abataceptDRUG

Intravenous Infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has rheumatoid arthritis (RA), is both abatacept- and belatacept-naïve, and is an eligible candidate to start a course of treatment with abatacept in accordance with the product label * Subject is willing and able to comply with study visits and procedures

Locations (7)

Pinnacle Research Group, LLC

Anniston, Alabama, United States

Arthritis Research of Florida

Palm Harbor, Florida, United States

The Center for Rheumatology and Bone Research

Wheaton, Maryland, United States

North Shore - Long Island Jewish Health System

Lake Success, New York, United States

Outcomes

Primary Outcomes

CD86 Receptor Occupancy

Time frame: Day 1, Weeks 2, 4, 8, and 12

Secondary Outcomes

CD80 Receptor Occupancy

Time frame: Day 1, Weeks 2, 4, 8, and 12

Abatacept serum concentration

Time frame: Day 1, Weeks 2, 4, 8 and 12

Change from Day 1 to Week 12 in Subject's Global Assessment of Arthritis

Time frame: Day 1 and Week 12

Change from Day 1 to Week 12 in Physician's Global Assessment of Arthritis

Time frame: Day 1 and Week 12

Safety assessed by adverse event reporting including Physical Examination findings

Time frame: Day 1 through Week 12 post-infusion

Data from ClinicalTrials.gov

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