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

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: abatacept

• Registration Number: NCT01339481
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-04-13
• Study First Submitted QC: 2011-04-19
• Study First Posted: 2011-04-20
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-28
• Last Update Posted: 2011-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with RA initiating abatacept treatment regimen	abatacept	Subjects naïve to both abatacept and belatacept

Primary Outcome Measures

Name	Time	Method
CD86 Receptor Occupancy	Day 1, Weeks 2, 4, 8, and 12

Secondary Outcome Measures

Name	Time	Method
Abatacept serum concentration	Day 1, Weeks 2, 4, 8 and 12
Change from Day 1 to Week 12 in Subject's Global Assessment of Arthritis	Day 1 and Week 12
CD80 Receptor Occupancy	Day 1, Weeks 2, 4, 8, and 12
Change from Day 1 to Week 12 in Physician's Global Assessment of Arthritis	Day 1 and Week 12
Safety assessed by adverse event reporting including Physical Examination findings	Day 1 through Week 12 post-infusion

Trial Locations

Locations (7)

Pinnacle Research Group, LLC; 🇺🇸 Anniston, Alabama, United States

The Center for Rheumatology and Bone Research; 🇺🇸 Wheaton, Maryland, United States

Arthritis Research of Florida; 🇺🇸 Palm Harbor, Florida, United States

North Shore - Long Island Jewish Health System; 🇺🇸 Lake Success, New York, United States

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Low County Rheumatology; 🇺🇸 North Charleston, South Carolina, United States

Metroplex Clinical Research Center; 🇺🇸 Dallas, Texas, United States