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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

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

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: abatacept

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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : February 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

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




Primary Outcome Measures :
  1. CD86 Receptor Occupancy [ Time Frame: Day 1, Weeks 2, 4, 8, and 12 ]

Secondary Outcome Measures :
  1. CD80 Receptor Occupancy [ Time Frame: Day 1, Weeks 2, 4, 8, and 12 ]
  2. Abatacept serum concentration [ Time Frame: Day 1, Weeks 2, 4, 8 and 12 ]
  3. Change from Day 1 to Week 12 in Subject's Global Assessment of Arthritis [ Time Frame: Day 1 and Week 12 ]
  4. Change from Day 1 to Week 12 in Physician's Global Assessment of Arthritis [ Time Frame: Day 1 and Week 12 ]
  5. Safety assessed by adverse event reporting including Physical Examination findings [ Time Frame: Day 1 through Week 12 post-infusion ]

Biospecimen Retention:   Samples Without DNA
whole blood, serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with Rheumatoid Arthritis
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339481


Locations
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United States, Alabama
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
United States, Florida
Arthritis Research of Florida
Palm Harbor, Florida, United States, 34684
United States, Maryland
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States, 20902
United States, New York
North Shore - Long Island Jewish Health System
Lake Success, New York, United States, 11042
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Low County Rheumatology
North Charleston, South Carolina, United States, 29406
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Astellas Pharma Inc
Perseid Therapeutics LLC
Investigators
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Study Director: Medical Director Astellas Pharma Global Development
Principal Investigator: Principal Investigator Metroplex Clinical Research Center

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01339481     History of Changes
Other Study ID Numbers: 2408-CL-0103
First Posted: April 20, 2011    Key Record Dates
Last Update Posted: November 29, 2011
Last Verified: November 2011
Keywords provided by Astellas Pharma Inc:
Orencia
Abatacept
Rheumatoid Arthritis
Infusion
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents