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

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ClinicalTrials.gov Identifier: NCT01555879
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Arthritis Northwest PLLC

Tracking Information
First Submitted Date February 29, 2012
First Posted Date March 16, 2012
Last Update Posted Date November 6, 2017
Study Start Date March 2012
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 14, 2012)
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. ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01555879 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 14, 2012)
  • 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. ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Real-world Clinical Efficacy of Abatacept in the T3 Data Registry
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
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Arthritis, Rheumatoid
Intervention Drug: Abatacept
As prescribed by a doctor for patient medical care.
Other Name: Orencia Intravenous
Study Groups/Cohorts All patients
All patients in T3 who have used Abatacept for at least 3 months between 2009-03-17 and 2011-11-30.
Intervention: Drug: Abatacept
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 14, 2012)
200
Original Estimated Enrollment Same as current
Actual Study Completion Date November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01555879
Other Study ID Numbers IM101-322
ANW_20110816 ( Other Identifier: Arthritis Northwest )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Arthritis Northwest PLLC
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
PRS Account Arthritis Northwest PLLC
Verification Date November 2017