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Predictors of Adherence to Orencia

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01136707
First received: June 2, 2010
Last updated: August 20, 2010
Last verified: August 2010
History of Changes
  Purpose

The purpose of this study is to examine the relationship between loading dose and adherence to Orencia.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predictors of Adherence to Orencia

Resource links provided by NLM:

Drug Information available for: Abatacept
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Total number of days on Orencia therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rheumatoid arthritis-related and total healthcare costs [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 422
Study Start Date: December 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with rheumatoid arthritis new to Orencia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Commercial health plan members

Criteria

Inclusion Criteria:

  • Patients will be identified based on the presence of first infusion claim during study period for Orencia
  • At least 1 medical or facility claim for rheumatoid arthritis at the time of or 6 months prior to index date
  • Patients are required to be continuously enrolled for a minimum pre-index and follow-up period as detailed below
  • Patients with a minimum of 3 infusion claims for Orencia
  • Only those patients will be included whose first 3 infusion claims occur within 84 days

Exclusion Criteria:

  • Patients less than 18 years of age at index date.
  • One or more diagnoses of regional enteritis (including Crohn's disease), ulcerative colitis, anal or intestinal fistula, ankylosing spondylitis or other inflammatory spondylopathy, psoriatic arthropathy, or psoriasis any time during the 6-month pre-index period
  • Patients who switch between biologics within their first three infusion claims
  • Restarts, defined as those patients who go back on Orencia after a gap of 42 days
  • Patients who are on other biologics at the same time as Orencia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136707

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01136707     History of Changes
Other Study ID Numbers: IM101-266
Study First Received: June 2, 2010
Last Updated: August 20, 2010
Health Authority: United States: No Health Authority

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013