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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339481
• Other study ID #: 2408-CL-0103
• Status: Completed
• Phase: N/A
• First received: April 13, 2011
• Last updated: November 28, 2011
• Start date: February 2011
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• abatacept
Intravenous Infusion

Locations

Country	Name	City	State
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	North Shore - Long Island Jewish Health System	Lake Success	New York
United States	Low County Rheumatology	North Charleston	South Carolina
United States	Arthritis Research of Florida	Palm Harbor	Florida
United States	The Center for Rheumatology and Bone Research	Wheaton	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Perseid Therapeutics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD86 Receptor Occupancy		Day 1, Weeks 2, 4, 8, and 12	No
Secondary	CD80 Receptor Occupancy		Day 1, Weeks 2, 4, 8, and 12	No
Secondary	Abatacept serum concentration		Day 1, Weeks 2, 4, 8 and 12	No
Secondary	Change from Day 1 to Week 12 in Subject's Global Assessment of Arthritis		Day 1 and Week 12	No
Secondary	Change from Day 1 to Week 12 in Physician's Global Assessment of Arthritis		Day 1 and Week 12	No
Secondary	Safety assessed by adverse event reporting including Physical Examination findings		Day 1 through Week 12 post-infusion	No