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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01339481

Enrollment

Registered

2011-04-20

Start date

2011-02-28

Completion date

2011-10-31

Last updated

2011-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Orencia, Abatacept, Rheumatoid Arthritis, Infusion

Brief summary

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

Interventions

DRUGabatacept

Intravenous Infusion

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
CD86 Receptor Occupancy	Day 1, Weeks 2, 4, 8, and 12

Secondary

Measure	Time frame
CD80 Receptor Occupancy	Day 1, Weeks 2, 4, 8, and 12
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
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026