Effect of Patient Cost Sharing on Treatment Discontinuation Among Rheumatoid Arthritis Patients

Rheumatoid Arthritis Clinical Trial

Official title:

Effect of Patient Cost Sharing on Treatment Discontinuation Among Rheumatoid Arthritis Patients Treated With Biologic Disease Modifying Antirheumatic Drug (DMARD) Therapies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137851
• Other study ID #: IM101-256
• Status: Completed
• Phase: N/A
• First received: June 3, 2010
• Last updated: September 30, 2010
• Start date: November 2009
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• 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 assess the impact of patient cost sharing on treatment discontinuation of biologic agents in patients with Rheumatoid Arthritis (RA)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3940
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Patients diagnosed with Rheumatoid Arthritis (RA) who newly initiated a biologic DMARD (bDMARD) during a study timeframe of 1/01/06 to 3/31/09.

Inclusion Criteria:

• 18 to 64 years of age at index date

• Diagnosis of RA during the study period (ICD-9CM 714.xx)

• Evidence of at least one biologic DMARD of interest during the study timeframe

• Continuous enrollment during the study timeframe

• Both medical and pharmacy benefits

• No evidence of a claim for a bDMARD in the 6-month pre-period

Exclusion Criteria:

• Patients are excluded if they have a diagnosis of psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, or ulcerative colitis at any time during the study timeframe; have a claim for Rituxan, IV etanercept, or IV adalimumab; or have Medicare or Medicaid during the study timeframe

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthritis
• 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	Effect of patient cost share on discontinuation		Assessed from first prescription date and followed for 1-year	No
Secondary	RA-related healthcare utilization and costs		Pre-index: 6-month period prior to the index drug date	No
Secondary	All-cause healthcare utilization and costs		Pre-index: 6-month period prior to the index drug date	No
Secondary	RA-related healthcare utilization and costs		Post-period: Index date+365 days	No
Secondary	All-cause healthcare utilization and costs		Post-period: Index date+365 days	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