Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT02332460
Status:
UNKNOWN
Last Update Posted:
2023-08-01
First Post:
2014-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infusion Related Reactions in Patients Receiving Infliximab
Sponsor:
Haukeland University Hospital
Organization:
Study Overview
Official Title:
Incidence, Risk Factors and Immunologic Mechanisms of Infusion Related Reactions in Patients With Chronic Inflammatory Disease Receiving Infliximab
Status:
UNKNOWN
Status Verified Date:
2023-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Infliximab is the active ingredient in a drug currently sold by the trade names Remicade, Remsima and Inflectra. Infliximab neutralizes tumor necrosis factor (TNF) α, a chemical messenger (cytokine) in the immune system, and belongs to a class of drugs called "TNF inhibitors". 8-55% of patients receiving infliximab have an infusion reaction. Infusion reactions are unintended reactions that occur during infusion of the drug and up to 14 days after. The incidence varies widely in different studies and seems difficult to determine due to variations in reporting of reactions, different definitions of reactions and retrospective data collection. The aim of this study is to estimate the incidence of infusion related reactions and investigate risk factors and immunological mechanisms of infusion reactions to infliximab in patients with a chronic inflammatory disease.
Detailed Description:
Background: Infliximab is the active ingredient in a drug currently sold by the trade names Remicade, Remsima and Inflectra. Infliximab neutralizes tumor necrosis factor (TNF) α, a chemical messenger (cytokine) in the immune system, and belongs to a class of drugs called "TNF inhibitors". This class of drug comprises effective, biological agents used in the treatment of chronic inflammatory diseases. The use of TNF inhibitors is increasing, and infliximab is the third bestselling drug by value in Norway in 2013. By being a recombinant monoclonal antibody with a murine region, infliximab is associated with infusion reactions. 8-55% of patients receiving infliximab have an infusion reaction. Infusion reactions are unintended reactions that occur during infusion of the drug and up to 14 days after. The incidence varies widely in different studies and seems difficult to determine due to variations in reporting of reactions, different definitions of reactions and retrospective data collection. Protective factors, risk factors and the causes of the reactions are not well known. Different treatment strategies are being used, but evidence of efficacy varies.
Aim: The aim of this study is to estimate the incidence of infusion related reactions and investigate risk factors and immunological mechanisms of infusion reactions to infliximab in patients with a chronic inflammatory disease.
Primary objective:
Estimate the incidence of infusion reactions in patients with chronic inflammatory disease receiving infliximab
Secondary objectives:
* Evaluate the correlation between infusion reactions and the formation of antibodies to infliximab.
* Identify individual risk factors for infusion reactions to infliximab.
* Identify immunological mechanisms of infusion reactions to infliximab.
* Identify immunomodulatory effects and immunological changes in the patients during treatment with infliximab.
Study population: The study will be a prospective, longitudinal study where all departments with patients starting infliximab or switching infliximab from one supplier to another in the Western Norway Health Region (Helse Vest RHF) are invited to participate.
Aim: The aim of this study is to estimate the incidence of infusion related reactions and investigate risk factors and immunological mechanisms of infusion reactions to infliximab in patients with a chronic inflammatory disease.
Primary objective:
Estimate the incidence of infusion reactions in patients with chronic inflammatory disease receiving infliximab
Secondary objectives:
* Evaluate the correlation between infusion reactions and the formation of antibodies to infliximab.
* Identify individual risk factors for infusion reactions to infliximab.
* Identify immunological mechanisms of infusion reactions to infliximab.
* Identify immunomodulatory effects and immunological changes in the patients during treatment with infliximab.
Study population: The study will be a prospective, longitudinal study where all departments with patients starting infliximab or switching infliximab from one supplier to another in the Western Norway Health Region (Helse Vest RHF) are invited to participate.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: