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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01555879
First Posted: March 16, 2012
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Arthritis Northwest PLLC
  Purpose
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)".

Condition Intervention
Arthritis, Rheumatoid Drug: Abatacept

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Arthritis Northwest PLLC:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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. ]
  • 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. ]

Enrollment: 200
Study Start Date: March 2012
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Orencia Intravenous

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555879


Locations
United States, Washington
Arthritis Northwest
Spokane, Washington, United States, 99208
Sponsors and Collaborators
Arthritis Northwest PLLC
Bristol-Myers Squibb
Investigators
Study Director: Keith Knapp, Ph.D. Arthritis Northwest PLLC
Principal Investigator: Gary Craig, M.D. Arthritis Northwest PLLC
  More Information

Publications:
Responsible Party: Arthritis Northwest PLLC
ClinicalTrials.gov Identifier: NCT01555879     History of Changes
Other Study ID Numbers: IM101-322
ANW_20110816 ( Other Identifier: Arthritis Northwest )
First Submitted: February 29, 2012
First Posted: March 16, 2012
Last Update Posted: November 6, 2017
Last Verified: November 2017

Keywords provided by Arthritis Northwest PLLC:
Retrospective
Database
Data warehouse
Data mining
Collaborative effectiveness
Comparative effectiveness
Outcome based medicine
Evidence based medicine

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents