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Study to Determine if the Flu Vaccine Increases the Risk of Muscle Damage in Participants Taking Drugs That Block Certain Proteins Made by Some Types of Immune System Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03644498
Recruitment Status : Active, not recruiting
First Posted : August 23, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
A retrospective, observational study conducted on cancer patients receiving a drug that blocks certain proteins made by some types of immune system cells

Condition or disease Intervention/treatment
Cancer Other: Non-Interventional

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk of Muscle Damage in Cancer Patients Exposed to the Influenza Vaccine While Receiving Checkpoint Inhibitor Therapies: A Nested Case Control Study Using Claims Data
Actual Study Start Date : May 2, 2018
Estimated Primary Completion Date : December 28, 2018
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Adults treated with a CPI therapy for cancer Other: Non-Interventional
Non-Interventional




Primary Outcome Measures :
  1. Incidence of myocarditis [ Time Frame: Approximately 7 years ]
  2. Incidence of myositis [ Time Frame: Approximately 7 years ]
  3. Incidence of rhabdomyolysis [ Time Frame: Approximately 7 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All participants in this study will be enrolled in the PharMetrics or MarketScan database and will have exposure to at least one checkpoint inhibitor
Criteria

Inclusion Criteria:

  • Treatment with a checkpoint inhibitor (CPI)
  • Age greater than or equal to 18 years on date of first claim for a CPI
  • ICD-9 or ICD-10 code for a malignancy within 180 days prior to the first claim for any CPI, and
  • Greater than or equal to 180 days of continuous pharmaceutical and medical benefit enrollment in the database prior to the first claim for any CPI

Exclusion Criteria:

  • Less than 18 years of age

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644498


Locations
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United States, New Jersey
Local Institution
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03644498     History of Changes
Other Study ID Numbers: CA209-99J
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bristol-Myers Squibb:
influenza
myositis
myocarditis
rhabdomyolysis
checkpoint inhibitors