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

NCT01137851 | Completed

• 1 other identifier: IM101-256
• Study Type: observational
• Target: 3,940
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Effect of patient cost share on discontinuation

  Assessed from first prescription date and followed for 1-year

Secondary Outcomes (4)

• RA-related healthcare utilization and costs

  Pre-index: 6-month period prior to the index drug date

• All-cause healthcare utilization and costs

  Pre-index: 6-month period prior to the index drug date

• RA-related healthcare utilization and costs

  Post-period: Index date+365 days

• All-cause healthcare utilization and costs

  Post-period: Index date+365 days

Study Arms (1)

New to bDMARD

New to bDMARD RA patients with high and low cost share who continue or discontinue treatment

Eligibility Criteria

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

Study Population

Commercial health plan members

You may qualify if:

• 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

You may not qualify if:

• 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

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 3, 2010
• First Posted: June 7, 2010
• Study Start: November 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 1, 2010

Record last verified: 2010-09