Infusion Related Reactions in Patients Receiving Infliximab

NCT02332460 | Unknown

• 1 other identifier: 2014/1368
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Inflammatory Disease

Outcome Measures

Primary Outcomes (1)

• incidence of infusion reactions

  participants will be followed for the duration of treatment, an expected average of 62 weeks

Secondary Outcomes (5)

• antibodies to infliximab

  followed for the duration of treatment, an expected average of 62 weeks

• immunological mechanisms of infusion reactions to infliximab

  baseline (before infusion), during reaction, 12-24 hours after reaction

• autoantibodies and other immunological changes in the patients during treatment with infliximab

  followed for the duration of treatment, an expected average of 62 weeks

• individual risk factors for infusion reactions to infliximab

  baseline

• antibodies to pneumococci and influenza

  baseline and 6-8 weeks after vaccination

Study Arms (1)

Infliximab

Patients treated with Infliximab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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 Regional Health Authority (Helse Vest RHF) are invited to participate.

You may qualify if:

• 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

You may not qualify if:

• Patients not completing treatment within Health Region
• Patients not able to complete sampling procedure

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

immunological and biochemical biomarkers, autoimmune antibodies, antibodies to infliximab, allergy analysis, concentrations of drugs (Infliximab, Metothrexat, and Imurel), HLA type

Study Officials

• Torunn Apelseth, MD, PhD

  Laboratory of Clinical Biochemistry, Haukeland University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2014
• First Posted: January 6, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)