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

NCT01555879 | Completed

• 2 other identifiers: IM101-322ANW_20110816
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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)".

Conditions

Arthritis, Rheumatoid

Keywords

Retrospective; Database; Data warehouse; Data mining; Collaborative effectiveness; Comparative effectiveness; Outcome based medicine; Evidence based medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

• 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.

Study Arms (1)

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

Interventions

Abatacept DRUG

As prescribed by a doctor for patient medical care.

Also known as: Orencia Intravenous

All patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Arthritis Northwest PLLC: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Arthritis Northwest

Spokane, Washington, 99208, United States

Location

Related Publications (2)

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

  BACKGROUND

• 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.

  PMID: 18793006 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• Keith Knapp, Ph.D.

  Arthritis Northwest PLLC

  STUDY DIRECTOR

• Gary Craig, M.D.

  Arthritis Northwest PLLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: March 16, 2012
• Study Start: March 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

US (1)