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Safety Profile of Nulojix in Home Infusion Settings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02500498
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : July 16, 2015
BiologicTx, LLC
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Nulojix

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Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Safety Profile of Nulojix in Home Infusion Settings
Study Start Date : October 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Belatacept

Primary Outcome Measures :
  1. Proportion of infusion related serious adverse events in adult kidney-only transplant recipients who are treated with belatacept in home infusion settings [ Time Frame: 24 hours after the date of a home infusion visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Home infusion service visit

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02500498

Sponsors and Collaborators
Bristol-Myers Squibb
BiologicTx, LLC
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb Identifier: NCT02500498    
Other Study ID Numbers: IM103-370
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents