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NCT02739386 Clinical Trial

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

Melanoma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02739386
Other study ID # CA184-486
Secondary ID
Status Completed
Phase N/A
First received April 7, 2016
Last updated April 25, 2017
Start date February 29, 2016
Est. completion date March 30, 2017

Study information
Verified date April 2017
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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?

Recruitment information / eligibility
Status Completed
Enrollment 370
Est. completion date March 30, 2017
Est. primary completion date March 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Ipilimumab
Intravenous monoclonal antibody injection

Locations
Country Name City State
United States Bristol-Myers Squibb Princeton New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of ipilimumab treatment among adult melanoma patients with a prior or existing autoimmune disease/condition Approximately 40 months
Primary Incidence of hospitalizations related to the pre-existing autoimmune disease/condition following treatment with ipilimumab Approximately 40 months
Secondary Incidence rate of hospitalization related to a complication of the underlying autoimmune condition before exposure to ipilimumab treatment Approximately 40 months
Secondary Incidence rate of hospitalization related to a complication of the underlying autoimmune condition after exposure to ipilimumab treatment Approximately 40 months
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