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Completed

NCT Number: NCT01141413

Dose Escalation With Remicade® and Orencia®

The purpose of this study is to describe infliximab and abatacept dosing patterns (i.e., dosing amount and frequency) and costs among a population of managed care enrollees with RA. This study will also identify changes in infliximab and abatacept dosing over time and the implication these changes may have on the costs of medication administration.

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Key information

About this study

This study will be conducted in two parts. The primary analysis is a longitudinal analysis, where patients' health care claims from a period during which the patient was continuously enrolled in the health plan will be used to evaluate the primary outcome (i.e., dose escalation). The second analysis will be cross-sectional, where patients' health care claims from a fixed period of time (i.e., 2008) will be used to examine health care cost.

The final enrollment for the longitudinal portion of the study was 2,001 (1,306 infliximab and 695 abatacept patients). Final enrollment for the cross-sectional portion was 3,450 (2,646 infliximab and 806 abatacept patients). There may be some overlap in these numbers.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Commercial health plan enrollees with medical and pharmacy coverage
  • At least 3 claims on separate days for infliximab (HCPCS J1745) or abatacept (HCPCS C9230, J0129, J3590) administration during the subject identification period
  • The 3 initial claims for abatacept occurred within a 6-week period inclusive of the index date and the three initial claims for infliximab occur within a 9-week period inclusive of the index date
  • Presence of a diagnosis of RA (ICD-9-CM 714.xx)
  • Continuous enrollment during the baseline and follow-up periods
  • At least 18 years of age or older on the index date

Exclusion criteria

  • Prior exposure to the index medication during the baseline period
  • Diagnosis of psoriasis (ICD-9-CM 696.1), psoriatic arthritis (696.0), ankylosing spondylitis (720.0), Crohn's disease (555.x), or ulcerative colitis (556.x) in any position at any time during the study period
  • Exposure to alefacept (HCPCS J0215, C9211, C9212) or efalizumab (HCPCS S0162) at any time during the study period

Treatment and study plan

Primary outcomes

  1. Escalation in dosing amount or frequency

    Time frame: Throughout follow-up period (variable, between 6 weeks and 39 months)

Secondary outcomes

  1. Switch/discontinuation of index therapy

    Time frame: Throughout follow-up period (variable, between 6 weeks and 39 months)

  2. Number of infusions

    Time frame: Throughout follow-up period (variable, between 6 weeks and 39 months)

  3. Average dose per infusion

    Time frame: Throughout follow-up period (variable, between 6 weeks and 39 months)

  4. Frequency of infusions

    Time frame: Throughout follow-up period (variable, between 6 weeks and 39 months)

  5. Average costs per infusion

    Time frame: Throughout follow-up period (variable, between 6 weeks and 39 months)

  6. Health care resource utilization

    Time frame: Throughout follow-up period (variable, between 6 weeks and 39 months)

  7. Health care costs

    Time frame: Throughout follow-up period (variable, between 6 weeks and 39 months)

  8. Concurrent medication use

    Time frame: Throughout follow-up period (variable, between 6 weeks and 39 months)

  9. Time to maximum dose

    Time frame: Throughout follow-up period (variable, between 6 weeks and 39 months)

  10. Time to dose escalation

    Time frame: Throughout follow-up period (variable, between 6 weeks and 39 months)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Comparison of Dosing and Costs Between Rheumatoid Arthritis Patients Treated With Remicade® Versus Orencia®

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 10, 2010
Registry last updated
Apr 4, 2012

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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