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OpenTrials
Completed

NCT Number: NCT02739386

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

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?

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bristol-Myers Squibb

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ipilimumab

Biological

Intravenous monoclonal antibody injection

Other names: Yervoy®

Primary outcomes

  1. Incidence of ipilimumab treatment among adult melanoma patients with a prior or existing autoimmune disease/condition

    Time frame: Approximately 40 months

  2. Incidence of hospitalizations related to the pre-existing autoimmune disease/condition following treatment with ipilimumab

    Time frame: Approximately 40 months

Secondary outcomes

  1. Incidence rate of hospitalization related to a complication of the underlying autoimmune condition before exposure to ipilimumab treatment

    Time frame: Approximately 40 months

  2. Incidence rate of hospitalization related to a complication of the underlying autoimmune condition after exposure to ipilimumab treatment

    Time frame: Approximately 40 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 15, 2016
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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