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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02739386

Enrollment

370

Registered

2016-04-15

Start date

2016-02-29

Completion date

2017-03-30

Last updated

2017-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

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?

Interventions

BIOLOGICALIpilimumab

Intravenous monoclonal antibody injection

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026