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

NCT02739386 | Completed

• 1 other identifier: CA184-486
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 1

Brief Summary

The research questions to be addressed by this study are as follows:

1. 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. 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?

Conditions

Melanoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (1)

Cohort Population

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

Biological: Ipilimumab

Interventions

Ipilimumab BIOLOGICAL

Intravenous monoclonal antibody injection

Also known as: Yervoy®

Cohort Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with an underlying autoimmune disease treated with ipilimumab for advanced melanoma.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Bristol-Myers Squibb

Princeton, New Jersey, 08540, United States

Location

Related Links

• Investigator Inquiry Form

MeSH Terms

Conditions

Melanoma

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 15, 2016
• Study Start: February 29, 2016
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2017
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

US (1)