Safety Profile of Nulojix in Home Infusion Settings

July 15, 2015 updated by: Bristol-Myers Squibb
The study is a retrospective cohort study that utilizes medical records from the BiologicTx. Data accrual starts upon initial home infusion nurse visit until the most recent home infusion nurse visit. Infusion related adverse events are quantified as number of patients with adverse event over the total number of patients and number of event over total number of home infusion visits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

37

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

Home infusion service visit

Description

Inclusion Criteria:

  • All adult kidney-only transplant recipients currently receiving NULOJIX in BiologicTx home infusion service settings

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of infusion related serious adverse events in adult kidney-only transplant recipients who are treated with belatacept in home infusion settings
Time Frame: 24 hours after the date of a home infusion visit
24 hours after the date of a home infusion visit

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Collaborators

BiologicTx, LLC

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

October 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 15, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimate)

July 16, 2015

Study Record Updates

Last Update Posted (Estimate)

July 16, 2015

Last Update Submitted That Met QC Criteria

July 15, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM103-370

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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