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

April 25, 2017 updated by: Bristol-Myers Squibb

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

370

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Bristol-Myers Squibb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Intravenous monoclonal antibody injection
Other Names:
  • Yervoy®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2016

Primary Completion (Actual)

March 30, 2017

Study Completion (Actual)

March 30, 2017

Study Registration Dates

First Submitted

April 7, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA184-486

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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