Safety Profile of Nulojix in Home Infusion Settings

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT02500498
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-15
• Last Update Submitted: 2015-07-15
• Study First Posted: 2015-07-16
• Last Update Posted: 2015-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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