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

Completed

• Conditions: Melanoma

• Registration Number: NCT02739386
• Lead Sponsor: Bristol-Myers Squibb

Brief 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?

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-29
• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-15
• Primary Completion: 2017-03-30
• Study Completion: 2017-03-30
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of ipilimumab treatment among adult melanoma patients with a prior or existing autoimmune disease/condition	Approximately 40 months
Incidence of hospitalizations related to the pre-existing autoimmune disease/condition following treatment with ipilimumab	Approximately 40 months

Secondary Outcome Measures

Name	Time	Method
Incidence rate of hospitalization related to a complication of the underlying autoimmune condition after exposure to ipilimumab treatment	Approximately 40 months
Incidence rate of hospitalization related to a complication of the underlying autoimmune condition before exposure to ipilimumab treatment	Approximately 40 months

Trial Locations

Locations (1)

Bristol-Myers Squibb; 🇺🇸 Princeton, New Jersey, United States