Study of Autoimmune Disease Complications Following Ipilimumab Treatment Among Melanoma Patients With Underlying Autoimmune Diseases



Status:Active, not recruiting
Conditions:Skin Cancer, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:18 - Any
Updated:8/5/2016
Start Date:February 2016
End Date:December 2018

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Trial Summary
Trial Overview
Inclusion Criteria

Evaluation of Hospitalization for Complications of Autoimmune Disease Following Ipilimumab Treatment Among Melanoma Patients With Underlying Autoimmune Diseases Treated in Routine Clinical Practices in the US

The research questions to be addressed by this study are as follows:

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?


Inclusion Criteria:

- Received ipilimumab therapy between 03/01/2011 and 6/30/2014

- 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:

- Diagnosed with melanoma but NO record of exposure to ipilimumab

- No exposure to nivolumab (Opdivo ®) at any time
We found this trial at
1
site
Bristol-Myers Squibb
Princeton, New Jersey 08540
?
mi
from
Princeton, NJ
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