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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01339481
Date of registration: 13/04/2011
Prospective Registration: Yes
Primary sponsor: Astellas Pharma Inc
Public title: A Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept
Scientific 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
Date of first enrolment: February 2011
Target sample size: 26
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01339481
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Medical Director
Address: 
Telephone:
Email:
Affiliation:  Astellas Pharma Global Development
Name:     Principal Investigator
Address: 
Telephone:
Email:
Affiliation:  Metroplex Clinical Research Center
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: abatacept
Primary Outcome(s)
CD86 Receptor Occupancy [Time Frame: Day 1, Weeks 2, 4, 8, and 12]
Secondary Outcome(s)
Abatacept serum concentration [Time Frame: Day 1, Weeks 2, 4, 8 and 12]
CD80 Receptor Occupancy [Time Frame: Day 1, Weeks 2, 4, 8, and 12]
Change from Day 1 to Week 12 in Physician's Global Assessment of Arthritis [Time Frame: Day 1 and Week 12]
Change from Day 1 to Week 12 in Subject's Global Assessment of Arthritis [Time Frame: Day 1 and Week 12]
Safety assessed by adverse event reporting including Physical Examination findings [Time Frame: Day 1 through Week 12 post-infusion]
Secondary ID(s)
2408-CL-0103
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Perseid Therapeutics LLC
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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