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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Arthritis Northwest PLLC.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Arthritis Northwest PLLC
ClinicalTrials.gov Identifier:
NCT01555879
First received: February 29, 2012
Last updated: March 16, 2012
Last verified: March 2012
  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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2012
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: March 2012 (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

Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 29, 2012
Last Updated: March 16, 2012
Health Authority: United States: Institutional Review Board

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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Abatacept
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014