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Dose Escalation With Remicade® and Orencia®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01141413
First received: June 9, 2010
Last updated: April 3, 2012
Last verified: April 2012

June 9, 2010
April 3, 2012
January 2010
August 2010   (final data collection date for primary outcome measure)
Escalation in dosing amount or frequency [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01141413 on ClinicalTrials.gov Archive Site
  • Switch/discontinuation of index therapy [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
  • Number of infusions [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
  • Average dose per infusion [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
  • Frequency of infusions [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
  • Average costs per infusion [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
  • Health care resource utilization [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
  • Health care costs [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
  • Concurrent medication use [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
  • Time to maximum dose [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
  • Time to dose escalation [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dose Escalation With Remicade® and Orencia®
Comparison of Dosing and Costs Between Rheumatoid Arthritis Patients Treated With Remicade® Versus 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Commercial health plan members

Rheumatoid Arthritis
Not Provided
  • RA patients using Remicade®
  • RA patients using Orencia®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5451
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01141413
IM101-255
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP