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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 22, 2014