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OpenTrials
Completed

NCT Number: NCT01555879

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

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)".

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Arthritis Northwest

Spokane, Washington, 99208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Abatacept

Drug

As prescribed by a doctor for patient medical care.

Other names: Orencia Intravenous

Primary outcomes

  1. 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

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Arthritis Northwest PLLC

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 16, 2012
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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