Predictors of Adherence to Orencia

Rheumatoid Arthritis Clinical Trial

Official title:

Predictors of Adherence to Orencia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136707
• Other study ID #: IM101-266
• Status: Completed
• Phase: N/A
• First received: June 2, 2010
• Last updated: September 15, 2016
• Start date: December 2009
• Est. completion date: July 2010

Study information

• Verified date: September 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: No Health Authority
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of days on Orencia therapy		6 months	No
Secondary	Rheumatoid arthritis-related and total healthcare costs		6 months	No

External Links

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