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

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ClinicalTrials.gov Identifier: NCT01339481
Recruitment Status : Completed
First Posted : April 20, 2011
Last Update Posted : November 29, 2011
Sponsor:
Collaborator:
Perseid Therapeutics LLC
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date April 13, 2011
First Posted Date April 20, 2011
Last Update Posted Date November 29, 2011
Study Start Date February 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 19, 2011)
CD86 Receptor Occupancy [ Time Frame: Day 1, Weeks 2, 4, 8, and 12 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01339481 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 19, 2011)
  • CD80 Receptor Occupancy [ Time Frame: Day 1, Weeks 2, 4, 8, and 12 ]
  • Abatacept serum concentration [ Time Frame: 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 ]
  • Change from Day 1 to Week 12 in Physician'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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept
Official 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
Brief Summary The purpose of this study is to characterize CD86 receptor occupancy in subjects with rheumatoid arthritis (RA) receiving abatacept.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
whole blood, serum
Sampling Method Probability Sample
Study Population Subjects with Rheumatoid Arthritis
Condition Rheumatoid Arthritis
Intervention Drug: abatacept
Intravenous Infusion
Other Name: Orencia
Study Groups/Cohorts Subjects with RA initiating abatacept treatment regimen
Subjects naïve to both abatacept and belatacept
Intervention: Drug: abatacept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 28, 2011)
26
Original Estimated Enrollment
 (submitted: April 19, 2011)
25
Actual Study Completion Date October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01339481
Other Study ID Numbers 2408-CL-0103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Astellas Pharma Inc
Study Sponsor Astellas Pharma Inc
Collaborators Perseid Therapeutics LLC
Investigators
Study Director: Medical Director Astellas Pharma Global Development
Principal Investigator: Principal Investigator Metroplex Clinical Research Center
PRS Account Astellas Pharma Inc
Verification Date November 2011