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Healthcare Costs Among Patients With CML Receiving Dasatinib or Nilotinib in a Commercial and Medicare Population

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02363868
Collaborator
(none)
186
Enrollment
1
Location
9
Duration (Months)
20.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the healthcare costs among patients with CML receiving dasatinib or nilotinib as first line therapy in a commercially or Medicare insured population.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    186 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Costs and Outcome Among Patients With Chronic Myelogenous Leukemia (CML) Receiving Dasatinib or Nilotinib as First or Second Line Therapy in a Commercial and Medicare Population
    Study Start Date :
    Feb 1, 2014
    Actual Primary Completion Date :
    Nov 1, 2014
    Actual Study Completion Date :
    Nov 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    CML subjects receiving Dasatinib

    CML receiving dasatinib as first or second line therapy will be conducted to assess healthcare costs
    CML subjects receiving Nilotinib

    CML receiving nilotinib as first or second line therapy will be conducted to assess healthcare costs

    Outcome Measures

    Primary Outcome Measures

    1. Healthcare costs [Intent-to-treat (ITT) at 6 months]

      Average (mean) costs for patients receiving dasatinib or nilotinib as first line therapy

    Secondary Outcome Measures

    1. Healthcare costs by line of therapy [Intent-to-treat (ITT) at 6 months]

    2. Resource utilization by line of therapy [Intent-to-treat (ITT) at 6 months]

      Captured per number of hospitalizations, Emergency room (ER) visits, physician office visits, and medications / number of prescriptions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

    Inclusion Criteria:

    • Age >18 years

    • International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9 CM) code for CML (205.1x)

    • At least 2 prescriptions for dasatinib or nilotinib from July 1, 2008 to June 31, 2013

    • Continuous eligibility for the 6 months pre- and post-index date (defined as the date of first fill for dasatinib or nilotinib)

    Exclusion Criteria:
    • History of bone marrow or stem cell transplant as identified in the 6 month pre-period

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Franklin Pharmaceutical Consulting, Llc Clinton South Carolina United States 29325

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02363868
    Other Study ID Numbers:
    • CA180-568
    First Posted:
    Feb 16, 2015
    Last Update Posted:
    Jul 7, 2015
    Last Verified:
    Jul 1, 2015
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myelogenous, Chronic, BCR-ABL Positive

    Study Results

    No Results Posted as of Jul 7, 2015