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

November 2, 2017 updated by: Arthritis Northwest PLLC

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

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)".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Spokane, Washington, United States, 99208
        • Arthritis Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All rheumatoid arthritis patients from a single site who have been on Abatacept for greater than 3 months.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All patients
All patients in T3 who have used Abatacept for at least 3 months between 2009-03-17 and 2011-11-30.
Drug: Abatacept
As prescribed by a doctor for patient medical care.
Other Names:
  • Orencia Intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 6 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 3 months.
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.
Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 9 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arthritis Northwest PLLC

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: Keith Knapp, Ph.D., Arthritis Northwest PLLC
  • Principal Investigator: Gary Craig, M.D., Arthritis Northwest PLLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

February 29, 2012

First Submitted That Met QC Criteria

March 14, 2012

First Posted (Estimate)

March 16, 2012

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM101-322
  • ANW_20110816 (Other Identifier: Arthritis Northwest)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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