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Completed

NCT Number: NCT01137851

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

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)

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Effect of patient cost share on discontinuation

    Time frame: Assessed from first prescription date and followed for 1-year

Secondary outcomes

  1. RA-related healthcare utilization and costs

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

  2. All-cause healthcare utilization and costs

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

  3. RA-related healthcare utilization and costs

    Time frame: Post-period: Index date+365 days

  4. All-cause healthcare utilization and costs

    Time frame: Post-period: Index date+365 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 7, 2010
Registry last updated
Oct 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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