Overview

This trial is active, not recruiting.

Condition melanoma
Treatment ipilimumab
Target CTLA-4
Sponsor Bristol-Myers Squibb
Start date February 2016
End date December 2018
Trial size 370 participants
Trial identifier NCT02739386, CA184-486

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?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Individuals included in a large US-based administrative medical claims database with underlying autoimmune disorder exposed to ipilimumab for the treatment of melanoma.
ipilimumab Yervoy®
Intravenous monoclonal antibody injection

Primary Outcomes

Measure
Incidence of ipilimumab treatment among adult melanoma patients with a prior or existing autoimmune disease/condition
time frame: Approximately 40 months
Incidence of hospitalizations related to the pre-existing autoimmune disease/condition following treatment with ipilimumab
time frame: Approximately 40 months

Secondary Outcomes

Measure
Incidence rate of hospitalization related to a complication of the underlying autoimmune condition before exposure to ipilimumab treatment
time frame: Approximately 40 months
Incidence rate of hospitalization related to a complication of the underlying autoimmune condition after exposure to ipilimumab treatment
time frame: Approximately 40 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.