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

Information source: Arthritis Northwest PLLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arthritis, Rheumatoid

Intervention: Abatacept (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Arthritis Northwest PLLC

Official(s) and/or principal investigator(s):
Keith Knapp, Ph.D., Study Director, Affiliation: Arthritis Northwest PLLC
Gary Craig, M.D., Principal Investigator, Affiliation: Arthritis Northwest PLLC

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)".

Clinical Details

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

Study design: Observational Model: Case-Only, Time Perspective: Retrospective

Primary outcome: Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.

Secondary outcome:

Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.

Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosed with rheumatoid arthritis

- Have used Abatacept for 3 or more months

Exclusion Criteria:

- None

Locations and Contacts

Arthritis Northwest, Spokane, Washington 99208, United States
Additional Information

Related publications:

Michael Schiff, Coralie Poncet, and Manuela Le Bars International Journal of Clinical Rheumatology 2010 5:5, 581-591

Pincus T, Swearingen CJ, Bergman M, Yazici Y. RAPID3 (Routine Assessment of Patient Index Data 3), a rheumatoid arthritis index without formal joint counts for routine care: proposed severity categories compared to disease activity score and clinical disease activity index categories. J Rheumatol. 2008 Nov;35(11):2136-47. Epub 2008 Sep 15.

Starting date: March 2012
Last updated: March 16, 2012

Page last updated: August 23, 2015

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