Clinical trial NCT01555879: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Keywords: Retrospective
Database
Data warehouse
Data mining
Collaborative effectiveness
Comparative effectiveness
Outcome based medicine
Evidence based medicine
Lead sponsor: Arthritis Northwest PLLC
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2012-03-16
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.
timeFrame: Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 6 months.
Secondary outcomes:
measure: Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.
timeFrame: Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 3 months.
measure: Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.
timeFrame: Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 9 months.
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Arthritis Northwest
state: Washington
Study officials:
affiliation: Arthritis Northwest PLLC
name: Keith Knapp, Ph.D.
role: STUDY_DIRECTOR
affiliation: Arthritis Northwest PLLC
name: Gary Craig, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Michael Schiff, Coralie Poncet, and Manuela Le Bars International Journal of Clinical Rheumatology 2010 5:5, 581-591
citation: Pincus T, Swearingen CJ, Bergman M, Yazici Y. RAPID3 (Routine Assessment of Patient Index Data 3), a rheumatoid arthritis index without formal joint counts for routine care: proposed severity categories compared to disease activity score and clinical disease activity index categories. J Rheumatol. 2008 Nov;35(11):2136-47. doi: 10.3899/jrheum.080182. Epub 2008 Sep 15.