Overview

This trial is active, not recruiting.

Condition arthritis, rheumatoid
Treatment abatacept
Sponsor Arthritis Northwest PLLC
Collaborator Bristol-Myers Squibb
Start date March 2012
End date March 2012
Trial size 200 participants
Trial identifier NCT01555879, ANW_20110816, IM101-322

Summary

The purpose of this study is to assess the effectiveness of Abatacept in real-world clinical practice. The main hypothesis to be examined in this study is, "Abatacept's effectiveness results in a single real-world clinic (n = 100) are reproducible at another site (n ~= 200)".

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
Arm
All patients in T3 who have used Abatacept for at least 3 months between 2009-03-17 and 2011-11-30.
abatacept Orencia Intravenous
As prescribed by a doctor for patient medical care.

Primary Outcomes

Measure
Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.
time frame: Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 6 months.

Secondary Outcomes

Measure
Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.
time frame: Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 3 months.
Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.
time frame: Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 9 months.

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Diagnosed with rheumatoid arthritis - Have used Abatacept for 3 or more months Exclusion Criteria: - None

Additional Information

Official title Abatacept in T3: A Characterization of Abatacept's Efficacy and Outcomes From a Real-Word Clinical Practice Information Hub on Novel Patient Sub-Groups
Principal investigator Gary Craig, M.D.
Description Two secondary hypotheses that will be tested are: - Abatacept aids in achieving low disease activity or clinical remission in patients of the following Rheumatoid Arthritis (RA) sub-groups: RF+/CCP+, RF+/CCP- RF-/CCP+ RF-/CCP-; first time on a bio-tech drug; having previously failed a biological drug; having interstitial lung disease; identified as disabled; twenty-eight individual joints identified as {swollen, painful, tender, deformed or having decreased range of motion}; on or not on oral DMARD; age; or gender. - A database with sufficient attributes exists from which a patient's efficacy on abatacept is accurately predictable.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Arthritis Northwest PLLC.