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
1 other identifier
observational
26
1 country
7
Brief Summary
The purpose of this study is to characterize CD86 receptor occupancy in subjects with rheumatoid arthritis (RA) receiving abatacept.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2011
Shorter than P25 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 13, 2011
CompletedFirst Posted
Study publicly available on registry
April 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedNovember 29, 2011
November 1, 2011
8 months
April 13, 2011
November 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CD86 Receptor Occupancy
Day 1, Weeks 2, 4, 8, and 12
Secondary Outcomes (5)
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
Study Arms (1)
Subjects with RA initiating abatacept treatment regimen
Subjects naïve to both abatacept and belatacept
Interventions
Intravenous Infusion
Eligibility Criteria
Subjects with Rheumatoid Arthritis
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Perseid Therapeutics LLCcollaborator
Study Sites (7)
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
Biospecimen
whole blood, serum
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development
- PRINCIPAL INVESTIGATOR
Principal Investigator
Metroplex Clinical Research Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2011
First Posted
April 20, 2011
Study Start
February 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
November 29, 2011
Record last verified: 2011-11