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
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of Dosing and Costs Between Rheumatoid Arthritis Patients Treated With Remicade® Versus Orencia®

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Escalation in dosing amount or frequency [ Time Frame: Throughout follow-up period (variable, between 6 weeks and 39 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 5451
Study Start Date: January 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
RA patients using Remicade®
RA patients using Orencia®

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Commercial health plan members

Criteria

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
  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: NCT01141413

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01141413     History of Changes
Other Study ID Numbers: IM101-255
Study First Received: June 9, 2010
Last Updated: April 3, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 28, 2014