Safety Profile of Nulojix in Home Infusion Settings
1 other identifier
observational
37
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2014
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 15, 2015
CompletedFirst Posted
Study publicly available on registry
July 16, 2015
CompletedJuly 16, 2015
July 1, 2015
8 months
July 15, 2015
July 15, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
Eligibility Criteria
Home infusion service visit
You may qualify if:
- All adult kidney-only transplant recipients currently receiving NULOJIX in BiologicTx home infusion service settings
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- BiologicTx, LLCcollaborator
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2015
First Posted
July 16, 2015
Study Start
October 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
July 16, 2015
Record last verified: 2015-07