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

Completed

• Conditions: Melanoma
• Interventions: Biological: Ipilimumab

• 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

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Exclusion Criteria

• Diagnosed with melanoma but NO record of exposure to ipilimumab
• No exposure to nivolumab (Opdivo ®) at any time

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort Population	Ipilimumab	Individuals included in a large US-based administrative medical claims database with underlying autoimmune disorder exposed to ipilimumab for the treatment of melanoma.

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