Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars

July 25, 2023 updated by: Catherine M. Lockhart

An Exploratory Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars in Real-world Practice

This comparative effectiveness and descriptive retrospective cohort study will evaluate safety and effectiveness outcomes among commercially insured adults who received a granulocyte colony stimulating factor (G-CSF) biosimilar or originator product during the first cycle of clinical guideline-indicated intermediate or high febrile neutropenia risk chemotherapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This comparative effectiveness and descriptive retrospective cohort study includes commercially insured adults enrolled in one of four health plans participating in the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) Distributed Research Network. The investigators included patients who received a granulocyte colony stimulating factor (G-CSF) biosimilar or originator product during the first cycle of clinical guideline-indicated intermediate or high febrile neutropenia risk chemotherapy. The investigators will collect patient demographics, cancer diagnosis, chemotherapy regimen, and patterns of G-CSF biosimilar and originator product use. The investigators will follow patients from first G-CSF exposure until up to six cycles of chemotherapy receipt, death, or insurance disenrollment. The primary effectiveness outcome is incidence of febrile neutropenia. Secondary outcomes include incidence of adverse events and trends in product use over time. The investigators will compare febrile neutropenia incidence between originator and biosimilar products using inverse probability weighting to control for confounding. Secondary analyses will examine 'as treated' outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16506

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with lung, breast, colon, ovarian, pancreatic, testicular, cervical, uterine, or NHL cancers initiating clinical guideline-indicated intermediate or high neutropenia risk chemotherapy between March 1, 2015 and December 31, 2019. Study period observation ends by June 30, 2020 for participant follow-up. A 12-month look-back prior to the study period (i.e. as early as March 1, 2014) will be used to ensure health plan enrollment, find incident cancer diagnoses, and provide a description of reference G-CSF utilization before biosimilar introduction to the US market.

Description

Inclusion Criteria:

  • Patients age 20 or older
  • Diagnosis of lung, breast, colon, ovarian, pancreatic, testicular, cervical, uterine, or NHL cancer
  • Beginning intermediate or high neutropenia risk chemotherapy

Exclusion Criteria:

  • One inpatient or two outpatient cancer diagnoses at least 30 days apart in the 183 days prior to the Index Date for cancer different from enrolling cancer diagnosis
  • Any of the following in 183 days prior to Index Date:
  • Any chemotherapy or G-CSF product receipt
  • 2< medical claims at least 30 days apart for a skilled nursing facility or hospice care
  • 2< diagnoses/procedure codes at least 1 day apart for cancer-related radiotherapy, bone marrow or stem cell transplant, diagnosis of HIV/AIDS, severe hepatic disease, chronic kidney disease, or any non-oncology related neutropenia

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
G-CSF originator receipt
Patients receiving filgrastim (Neupogen) or pegfilgrastim (Neulasta) per Health Care Procedural Coding System (HCPCS) J-codes.
Drug: Receipt of granulocyte-colony stimulating factor
Receipt of originator or biosimilar
G-CSF biosimilar receipt
Patients receiving filgrastim biosimilars (filgrastim-aafi, filgrastim-sndz, tbo-filgrastim) or pegfilgrastim biosimilars (pegfilgrastim-jmdb, pegfilgrastim-bmez, pegfilgrastim-cbqv) per Health Care Procedural Coding System (HCPCS) J-codes.
Drug: Receipt of granulocyte-colony stimulating factor
Receipt of originator or biosimilar

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patients who develop febrile neutropenia
Time Frame: Within 30 days of receipt of first chemotherapy
ICD-9 or ICD-10 codes for inpatient or outpatient visit indicating fever with infection per validated algorithms.
Within 30 days of receipt of first chemotherapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients who develop G-CSF associated adverse events
Time Frame: Within 30 days of receipt of first chemotherapy
ICD-9 or ICD-10 codes indicating splenic rupture, anaphylaxis, or leukocytosis.
Within 30 days of receipt of first chemotherapy

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Catherine M. Lockhart

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
HealthPartners Institute
Harvard Pilgrim Health Care

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BBCIC-GCSF-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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