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Safety Profile of Nulojix in Home Infusion Settings

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Nulojix (Drug)

Phase: N/A

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

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.

Clinical Details

Official title: Safety Profile of Nulojix in Home Infusion Settings

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome: Proportion of infusion related serious adverse events in adult kidney-only transplant recipients who are treated with belatacept in home infusion settings

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- All adult kidney-only transplant recipients currently receiving NULOJIX in BiologicTx

home infusion service settings

Locations and Contacts

Additional Information

BMS Clinical Trial Information

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: October 2014
Last updated: July 15, 2015

Page last updated: August 23, 2015

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