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

NCT ID: NCT01555879

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Arthritis, Rheumatoid

Keywords

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Retrospective Database Data warehouse Data mining Collaborative effectiveness Comparative effectiveness Outcome based medicine Evidence based medicine

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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All patients

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

Abatacept

Intervention Type DRUG

As prescribed by a doctor for patient medical care.

Interventions

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Abatacept

As prescribed by a doctor for patient medical care.

Intervention Type DRUG

Other Intervention Names

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Orencia Intravenous

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Arthritis Northwest PLLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keith Knapp, Ph.D.

Role: STUDY_DIRECTOR

Arthritis Northwest PLLC

Gary Craig, M.D.

Role: PRINCIPAL_INVESTIGATOR

Arthritis Northwest PLLC

Locations

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Arthritis Northwest

Spokane, Washington, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND

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. doi: 10.3899/jrheum.080182. Epub 2008 Sep 15.

Reference Type BACKGROUND
PMID: 18793006 (View on PubMed)

Other Identifiers

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ANW_20110816

Identifier Type: OTHER

Identifier Source: secondary_id

IM101-322

Identifier Type: -

Identifier Source: org_study_id