Chronic Inflammatory DiseaseNCT02332460
Infusion Related Reactions in Patients Receiving Infliximab
An observational study of Chronic Inflammatory Disease, run by Haukeland University Hospital at 1 site in Norway.
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". Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Inflammatory Disease
- How many people
- 125 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2015to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients not completing treatment within Health Region
- Patients not able to complete sampling procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence, Risk Factors and Immunologic Mechanisms of Infusion Related Reactions in Patients With Chronic Inflammatory Disease Receiving Infliximab
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.
Read the 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.
- Conditions
- Chronic Inflammatory Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infliximab | Patients treated with Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of infusion reactions
Measured: participants will be followed for the duration of treatment, an expected average of 62 weeks
Secondary outcomes (5)
antibodies to infliximab
Specific IgG and IgE against ifliximab
Measured: followed for the duration of treatment, an expected average of 62 weeks
immunological mechanisms of infusion reactions to infliximab
allergy tests, cytokines, complement
Measured: baseline (before infusion), during reaction, 12-24 hours after reaction
autoantibodies and other immunological changes in the patients during treatment with infliximab
Measured: followed for the duration of treatment, an expected average of 62 weeks
individual risk factors for infusion reactions to infliximab
HLA type, allergic predisposition
Measured: baseline
antibodies to pneumococci and influenza
Measured: baseline and 6-8 weeks after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory DiseaseStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torunn Apelseth, MD, PhD, Study director, Laboratory of Clinical Biochemistry, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332460
- Sponsor's protocol ID
- 2014/1368
- Status last verified
- Jul 2023
- First submitted
- 28 Nov 2014
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factors and Immunologic Mechanisms of Infusion Related Reactions in Patients With Chronic Inflammatory Disease Receiving Infliximab
- ClinicalTrials.gov ID
- NCT02332460
- Acronym / sponsor ID
- 2014/1368
- Conditions
- Chronic Inflammatory Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infliximab | – | –Patients treated with Infliximab |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients not completing treatment within Health Region
- Patients not able to complete sampling procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of infusion reactions
Time frame: participants will be followed for the duration of treatment, an expected average of 62 weeks
5 secondary outcomes
antibodies to infliximab
Time frame: followed for the duration of treatment, an expected average of 62 weeks
immunological mechanisms of infusion reactions to infliximab
Time frame: baseline (before infusion), during reaction, 12-24 hours after reaction
autoantibodies and other immunological changes in the patients during treatment with infliximab
Time frame: followed for the duration of treatment, an expected average of 62 weeks
individual risk factors for infusion reactions to infliximab
Time frame: baseline
antibodies to pneumococci and influenza
Time frame: baseline and 6-8 weeks after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torunn Apelseth, MD, PhD study director
Laboratory of Clinical Biochemistry, Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Inflammatory Disease, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of infusion reactions (time frame: participants will be followed for the duration of treatment, an expected average of 62 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.