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NCT Number: NCT01339481

A 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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pinnacle Research Group, LLC, Anniston, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abatacept

Drug

Intravenous Infusion

Other names: Orencia

Primary outcomes

  1. CD86 Receptor Occupancy

    Time frame: Day 1, Weeks 2, 4, 8, and 12

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Perseid Therapeutics LLC

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 20, 2011
Registry last updated
Nov 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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