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Safety Profile of Nulojix in Home Infusion Settings

Safety Profile of Nulojix in Home Infusion Settings

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02500498
Enrollment
37
Registered
2015-07-16
Start date
2014-10-31
Completion date
2015-06-30
Last updated
2015-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

DRUGNulojix

Sponsors

BiologicTx, LLC
CollaboratorINDUSTRY
Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Proportion of infusion related serious adverse events in adult kidney-only transplant recipients who are treated with belatacept in home infusion settings24 hours after the date of a home infusion visit

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026