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

July 3, 2015 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

186

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Clinton, South Carolina, United States, 29325
        • Franklin Pharmaceutical Consulting, Llc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Others: Retrospecitve database analysis of patients in a health plan

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare costs
Time Frame: Intent-to-treat (ITT) at 6 months
Average (mean) costs for patients receiving dasatinib or nilotinib as first line therapy
Intent-to-treat (ITT) at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare costs by line of therapy
Time Frame: Intent-to-treat (ITT) at 6 months
Intent-to-treat (ITT) at 6 months
Resource utilization by line of therapy
Time Frame: Intent-to-treat (ITT) at 6 months
Captured per number of hospitalizations, Emergency room (ER) visits, physician office visits, and medications / number of prescriptions
Intent-to-treat (ITT) at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

February 10, 2015

First Posted (Estimate)

February 16, 2015

Study Record Updates

Last Update Posted (Estimate)

July 7, 2015

Last Update Submitted That Met QC Criteria

July 3, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA180-568

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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