Predictors of Adherence to Orencia

NCT01136707 | Completed

• 1 other identifier: IM101-266
• Study Type: observational
• Target: 422
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Total number of days on Orencia therapy

  6 months

Secondary Outcomes (1)

• Rheumatoid arthritis-related and total healthcare costs

  6 months

Study Arms (1)

Patients with rheumatoid arthritis new to Orencia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Commercial health plan members

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 3, 2010
• Study Start: December 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 16, 2016

Record last verified: 2016-09