Study of Autoimmune Disease Complications Following Ipilimumab Treatment Among Melanoma Patients With Underlying Autoimmune Diseases
NCT ID: NCT02739386
Last Updated: 2017-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
370 participants
OBSERVATIONAL
2016-02-29
2017-03-30
Brief Summary
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1. What is the prevalence of ipilimumab use among adults with a history of autoimmune disease that received treatment with ipilimumab for advanced melanoma?
2. Do melanoma patients with a history of autoimmune disease experience complications that require hospitalization related to their underlying autoimmune disease following treatment with ipilimumab?
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cohort Population
Individuals included in a large US-based administrative medical claims database with underlying autoimmune disorder exposed to ipilimumab for the treatment of melanoma.
Ipilimumab
Intravenous monoclonal antibody injection
Interventions
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Ipilimumab
Intravenous monoclonal antibody injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 18 years or older at index date (initiation of ipilimumab)
* Diagnosed with melanoma before index
* Documented history of an autoimmune disease
* Have at least 6 months of continuous pharmaceutical and medical benefit enrollment prior to the index
* Have at least 3 months of continuous pharmaceutical and medical benefit enrollment following and including the index date
Exclusion Criteria
* No exposure to nivolumab (Opdivo ®) at any time
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Bristol-Myers Squibb
Princeton, New Jersey, United States
Countries
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Related Links
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Investigator Inquiry Form
Other Identifiers
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CA184-486
Identifier Type: -
Identifier Source: org_study_id
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