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

Arthritis, Rheumatoid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01555879
• Other study ID #: IM101-322
• Secondary ID: ANW_20110816
• Status: Completed
• Phase: N/A
• First received: February 29, 2012
• Last updated: November 2, 2017
• Start date: March 2012
• Est. completion date: November 2016

Study information

• Verified date: November 2017
• Source: Arthritis Northwest PLLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosed with rheumatoid arthritis

• Have used Abatacept for 3 or more months

Exclusion Criteria:

Related Conditions & MeSH terms

• Arthritis, Rheumatoid

Intervention

Drug:
• Abatacept
As prescribed by a doctor for patient medical care.

Locations

Country	Name	City	State
United States	Arthritis Northwest	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Arthritis Northwest PLLC	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

References & Publications (2)

Michael Schiff, Coralie Poncet, and Manuela Le Bars International Journal of Clinical Rheumatology 2010 5:5, 581-591

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. Epub 2008 Sep 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.		Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 6 months.
Secondary	Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.		Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 3 months.
Secondary	Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.		Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 9 months.