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

This study has been completed.
Sponsor:
Collaborator:
Perseid Therapeutics LLC
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01339481
First received: April 13, 2011
Last updated: November 28, 2011
Last verified: November 2011
History of Changes

April 13, 2011
November 28, 2011
February 2011
October 2011   (final data collection date for primary outcome measure)
CD86 Receptor Occupancy [ Time Frame: Day 1, Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01339481 on ClinicalTrials.gov Archive Site
  • CD80 Receptor Occupancy [ Time Frame: Day 1, Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Abatacept serum concentration [ Time Frame: Day 1, Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Change from Day 1 to Week 12 in Subject's Global Assessment of Arthritis [ Time Frame: Day 1 and Week 12 ] [ Designated as safety issue: No ]
  • Change from Day 1 to Week 12 in Physician's Global Assessment of Arthritis [ Time Frame: Day 1 and Week 12 ] [ Designated as safety issue: No ]
  • Safety assessed by adverse event reporting including Physical Examination findings [ Time Frame: Day 1 through Week 12 post-infusion ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

The purpose of this study is to characterize CD86 receptor occupancy in subjects with rheumatoid arthritis (RA) receiving abatacept.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

whole blood, serum
Probability Sample

Subjects with Rheumatoid Arthritis
Rheumatoid Arthritis
Drug: abatacept
Intravenous Infusion
Other Name: Orencia
Subjects with RA initiating abatacept treatment regimen
Subjects naïve to both abatacept and belatacept
Intervention: Drug: abatacept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01339481
2408-CL-0103
No
Astellas Pharma Inc
Astellas Pharma Inc
Perseid Therapeutics LLC
Study Director: Medical Director Astellas Pharma Global Development
Principal Investigator: Principal Investigator Metroplex Clinical Research Center
Astellas Pharma Inc
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP