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

Abatacept in T3: A Characterization of Abatacept's Efficacy and Outcomes From a Real-Word Clinical Practice Information Hub on Novel Patient Sub-Groups

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01555879
Enrollment
200
Registered
2012-03-16
Start date
2012-03-31
Completion date
2016-11-30
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Keywords

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

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.

Interventions

DRUGAbatacept

As prescribed by a doctor for patient medical care.

Sponsors

Bristol-Myers Squibb
CollaboratorINDUSTRY
Arthritis Northwest PLLC
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 3 months.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026