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NCT02500498 Clinical Trial

Safety Profile of Nulojix in Home Infusion Settings

Rheumatoid Arthritis Clinical Trial

Official title:
Safety Profile of Nulojix in Home Infusion Settings

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02500498
Other study ID # IM103-370
Secondary ID
Status Completed
Phase N/A
First received July 15, 2015
Last updated July 15, 2015
Start date October 2014
Est. completion date June 2015

Study information
Verified date July 2015
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority Country name: None
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• Nulojix

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Bristol-Myers Squibb BiologicTx, LLC

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
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