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Predictors of Adherence to Orencia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01136707
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : September 16, 2016
Information provided by:
Bristol-Myers Squibb

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

Condition or disease
Rheumatoid Arthritis

Study Type : Observational
Actual Enrollment : 422 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predictors of Adherence to Orencia
Study Start Date : December 2009
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

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

Patients with rheumatoid arthritis new to Orencia

Primary Outcome Measures :
  1. Total number of days on Orencia therapy [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Rheumatoid arthritis-related and total healthcare costs [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Commercial health plan members

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01136707

Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT01136707     History of Changes
Other Study ID Numbers: IM101-266
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents