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

November 28, 2011 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group, LLC
    • Florida
      • Palm Harbor, Florida, United States, 34684
        • Arthritis Research of Florida
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • The Center for Rheumatology and Bone Research
    • New York
      • Lake Success, New York, United States, 11042
        • North Shore - Long Island Jewish Health System
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Low County Rheumatology
    • Texas
      • Dallas, Texas, United States, 75231
        • Metroplex Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects with Rheumatoid Arthritis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects with RA initiating abatacept treatment regimen
Subjects naïve to both abatacept and belatacept
Drug: abatacept
Intravenous Infusion
Other Names:
  • Orencia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CD86 Receptor Occupancy
Time Frame: Day 1, Weeks 2, 4, 8, and 12
Day 1, Weeks 2, 4, 8, and 12

Secondary Outcome Measures

Outcome Measure
Time Frame
CD80 Receptor Occupancy
Time Frame: Day 1, Weeks 2, 4, 8, and 12
Day 1, Weeks 2, 4, 8, and 12
Abatacept serum concentration
Time Frame: Day 1, Weeks 2, 4, 8 and 12
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
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
Day 1 and Week 12
Safety assessed by adverse event reporting including Physical Examination findings
Time Frame: Day 1 through Week 12 post-infusion
Day 1 through Week 12 post-infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Perseid Therapeutics LLC

Investigators

  • Principal Investigator: Principal Investigator, Metroplex Clinical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

April 13, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (Estimate)

April 20, 2011

Study Record Updates

Last Update Posted (Estimate)

November 29, 2011

Last Update Submitted That Met QC Criteria

November 28, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2408-CL-0103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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