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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Melanoma

Treatments: Biological: Ipilimumab

Study type: Observational

Funder types: Industry

Identifiers

NCT02739386

CA184-486

Details and patient eligibility

About

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?

Enrollment: 370 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

370 participants in 1 patient group

Cohort Population

Description:

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

Treatment:

Biological: Ipilimumab