Infusion Related Reactions in Patients Receiving Infliximab

Chronic Inflammatory Disease Clinical Trial

Official title:

Incidence, Risk Factors and Immunologic Mechanisms of Infusion Related Reactions in Patients With Chronic Inflammatory Disease Receiving Infliximab

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02332460
• Other study ID #: 2014/1368
• Status: Active, not recruiting
• Start date: February 2015
• Est. completion date: January 2025

Study information

• Verified date: July 2023
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 125
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients treated with Infliximab due to chronic inflammatory disease included before start of treatment

• Weight at least 15 kg

• Control groups which may be included for investigations of secondary outcomes: age, gender, disease matched patients not receiving infliximab, healthy blood donors, other patients receiving pneumococci and influenza vaccines

Exclusion Criteria:

• Patients not completing treatment within Health Region

• Patients not able to complete sampling procedure

Related Conditions & MeSH terms

• Chronic Inflammatory Disease

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of infusion reactions		participants will be followed for the duration of treatment, an expected average of 62 weeks
Secondary	antibodies to infliximab	Specific IgG and IgE against ifliximab	followed for the duration of treatment, an expected average of 62 weeks
Secondary	immunological mechanisms of infusion reactions to infliximab	allergy tests, cytokines, complement	baseline (before infusion), during reaction, 12-24 hours after reaction
Secondary	autoantibodies and other immunological changes in the patients during treatment with infliximab		followed for the duration of treatment, an expected average of 62 weeks
Secondary	individual risk factors for infusion reactions to infliximab	HLA type, allergic predisposition	baseline
Secondary	antibodies to pneumococci and influenza		baseline and 6-8 weeks after vaccination