Dose Escalation With Remicade® and Orencia®

NCT01141413 | Completed

• 1 other identifier: IM101-255
• Study Type: observational
• Target: 5,451
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Escalation in dosing amount or frequency

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

Secondary Outcomes (10)

• Switch/discontinuation of index therapy

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

• Number of infusions

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

• Average dose per infusion

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

• Frequency of infusions

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

• Average costs per infusion

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

Study Arms (2)

RA patients using Remicade®

RA patients using Orencia®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Commercial health plan members

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• BMS Clinical Trials Disclosure
• Investigator Inquiry form
• For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 10, 2010
• Study Start: January 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 4, 2012

Record last verified: 2012-04