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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01137851
First received: June 3, 2010
Last updated: September 30, 2010
Last verified: September 2010
  Purpose

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)


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effect of Patient Cost Sharing on Treatment Discontinuation Among Rheumatoid Arthritis Patients Treated With Biologic Disease Modifying Antirheumatic Drug (DMARD) Therapies

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Effect of patient cost share on discontinuation [ Time Frame: Assessed from first prescription date and followed for 1-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • RA-related healthcare utilization and costs [ Time Frame: Pre-index: 6-month period prior to the index drug date ] [ Designated as safety issue: No ]
  • All-cause healthcare utilization and costs [ Time Frame: Pre-index: 6-month period prior to the index drug date ] [ Designated as safety issue: No ]
  • RA-related healthcare utilization and costs [ Time Frame: Post-period: Index date+365 days ] [ Designated as safety issue: No ]
  • All-cause healthcare utilization and costs [ Time Frame: Post-period: Index date+365 days ] [ Designated as safety issue: No ]

Enrollment: 3940
Study Start Date: November 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
New to bDMARD
New to bDMARD RA patients with high and low cost share who continue or discontinue treatment

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Commercial health plan members

Criteria

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
  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: NCT01137851

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: NCT01137851     History of Changes
Other Study ID Numbers: IM101-256
Study First Received: June 3, 2010
Last Updated: September 30, 2010
Health Authority: United States: No Health Authority

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 21, 2014