Study of Autoimmune Disease Complications Following Ipilimumab Treatment Among Melanoma Patients With Underlying Autoimmune Diseases
Completed
Conditions studied: Melanoma
In brief
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?
Key facts
- Study ID
- NCT02739386
- Run by
- Bristol-Myers Squibb
- People needed
- 370
- Starts
- 2016-02-29
- Expected to finish
- 2017-03-30
- Last updated by the study team
- 2017-04-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Diagnosed with melanoma but NO record of exposure to ipilimumab
- No exposure to nivolumab (Opdivo ®) at any time
Where it is running
- Bristol-Myers Squibb — Princeton, New Jersey, United States
Full record on ClinicalTrials.gov
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