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

Part of paid clinical trials in Princeton, New Jersey.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02739386
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — BIOLOGICAL
    Intravenous monoclonal antibody injection

Study Details

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?

Key Dates

Start date
Feb 29, 2016
Status verified
Apr 2017
Primary completion
Mar 30, 2017
Completion
Mar 30, 2017

Study Design

Enrollment
370 participants (actual)

Arms

  • Arm: 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.

Primary Outcome Measure

Incidence of ipilimumab treatment among adult melanoma patients with a prior or existing autoimmune disease/condition [ Time Frame: Approximately 40 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Bristol-Myers SquibbPrincetonNew Jersey08540-

Find similar trials in Princeton, NJ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Bristol-Myers Squibb· Princeton, NJ

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