Real-world Clinical Efficacy of Abatacept in the T3 Data Registry

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: Abatacept

• Registration Number: NCT01555879
• Lead Sponsor: Arthritis Northwest PLLC

Brief 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)".

Detailed 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.

Study Timeline

• Study First Submitted: 2012-02-29
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-16
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Diagnosed with rheumatoid arthritis
• Have used Abatacept for 3 or more months

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients	Abatacept	All patients in T3 who have used Abatacept for at least 3 months between 2009-03-17 and 2011-11-30.

Primary Outcome Measures

Name	Time	Method
Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.	Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 6 months.

Secondary Outcome Measures

Name	Time	Method
Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.	Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 9 months.

Trial Locations

Locations (1)

Arthritis Northwest; 🇺🇸 Spokane, Washington, United States