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

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: abatacept (Drug)

Phase: N/A

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Astellas Pharma Global Development
Principal Investigator, Principal Investigator, Affiliation: Metroplex Clinical Research Center

Summary

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

Clinical Details

Official title: A Phase 0, Open-Label, Multi-Center, Observational Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: CD86 Receptor Occupancy

Secondary outcome:

CD80 Receptor Occupancy

Abatacept serum concentration

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

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

Safety assessed by adverse event reporting including Physical Examination findings

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Pinnacle Research Group, LLC, Anniston, Alabama 36207, United States

Arthritis Research of Florida, Palm Harbor, Florida 34684, United States

The Center for Rheumatology and Bone Research, Wheaton, Maryland 20902, United States

North Shore - Long Island Jewish Health System, Lake Success, New York 11042, United States

Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States

Low County Rheumatology, North Charleston, South Carolina 29406, United States

Metroplex Clinical Research Center, Dallas, Texas 75231, United States

Additional Information

Starting date: February 2011
Last updated: November 28, 2011

Page last updated: August 23, 2015

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