Characterization of Immunogenicity of TNF Inhibitors in Arthritis Patients With Poorer Treatment Response.
NCT ID: NCT04731831
Last Updated: 2024-06-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
120 participants
Study Classification
OBSERVATIONAL
Study Start Date
2020-08-01
Study Completion Date
2025-12-30
Brief Summary
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The aim of the study is to explore whether the influence of gender, tobacco smoking and obesity on treatment response in tumor necrosis factor inhibitors (TNFIs) can be explained by high degree of inflammation, human leucocyte antigen (HLA) type, autoantibodies, TNF and TNFI concentration and presence of ADA.
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Detailed Description
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Tumor necrosis factor inhibitors (TNFIs) have been uses with success since 1999 in Denmark in treatment of various inflammatory diseases, eg. rheumatoid arthritis (RA), Chrohn's disease, psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
TNFIs block a central cytokine in the inflammatory process, tumor necrosis factor (TNF).
Because the drugs are large proteins, they are prone to trigger an immune response and elicit anti-drug antibodies(ADA).
Epidemiologic studies have revealed that groups of patients (women, tobacco smokers, obese patients) with inflammatory rheumatic diseases have a lower response to TNFIs. The reasons for this are not fully elucidated. The hypothesis is that immunogenicity and changed pharmacokinetic of TNFI are causes of the inferior response.
The investigators will carry out a prospective clinical studies of 120 arthritis patients (RA, PsA and AS) initiating treatment with adalimumab or infliximab. The patients will be followed for 12 months and will be registered in DANBIO as normal praxis. Blood samples will be collected at baseline, 2, 4 and 12 months or at termination of the treatment.
Genotypes, autoantibodies, inflammation markers, TNFI and ADA will be measured.
The aim of the study is to explore:
A: If differences between men and women with respect to different markers of inflammation, human leucocyte antigen (HLA), autoantibodies, TNFI concentration and presence of ADAs can explain the lower response and adherence to the treatment among women.
B: If differences between smokers and non-smokers with respect to different markers of inflammation, HLA, autoantibodies, TNFI concentration and presence of ADAs can explain the lower response and adherence to the treatment among patients with arthritis who smoke tobacco.
C: If differences between obese and normal weight patients with respect to different markers of inflammation, HLA, autoantibodies, TNFI concentration and presence of ADAs can explain the lower response and adherence to the treatment.
The study will contribute with new knowledge, which hopefully can make the treatment more personalized and efficient.
TNFIs block a central cytokine in the inflammatory process, tumor necrosis factor (TNF).
Because the drugs are large proteins, they are prone to trigger an immune response and elicit anti-drug antibodies(ADA).
Epidemiologic studies have revealed that groups of patients (women, tobacco smokers, obese patients) with inflammatory rheumatic diseases have a lower response to TNFIs. The reasons for this are not fully elucidated. The hypothesis is that immunogenicity and changed pharmacokinetic of TNFI are causes of the inferior response.
The investigators will carry out a prospective clinical studies of 120 arthritis patients (RA, PsA and AS) initiating treatment with adalimumab or infliximab. The patients will be followed for 12 months and will be registered in DANBIO as normal praxis. Blood samples will be collected at baseline, 2, 4 and 12 months or at termination of the treatment.
Genotypes, autoantibodies, inflammation markers, TNFI and ADA will be measured.
The aim of the study is to explore:
A: If differences between men and women with respect to different markers of inflammation, human leucocyte antigen (HLA), autoantibodies, TNFI concentration and presence of ADAs can explain the lower response and adherence to the treatment among women.
B: If differences between smokers and non-smokers with respect to different markers of inflammation, HLA, autoantibodies, TNFI concentration and presence of ADAs can explain the lower response and adherence to the treatment among patients with arthritis who smoke tobacco.
C: If differences between obese and normal weight patients with respect to different markers of inflammation, HLA, autoantibodies, TNFI concentration and presence of ADAs can explain the lower response and adherence to the treatment.
The study will contribute with new knowledge, which hopefully can make the treatment more personalized and efficient.
Conditions
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Arthritis, Rheumatoid
Arthritis, Psoriatic
Spondylitis, Ankylosing
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Patient with arthritis starting infliximab or adalimumab
Patients with Rheumatoid Artritis, Psoriatic Arthritis, Anchylosing Spondylitis starting treament with infliximab or adalimumab
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients \> 18 years
* Diagnosed with RA, PsA or AS.
* Starting treatment with infliximab or adalimumab.
* Co- treatment with csDMARD or glucocorticoid is acceptable.
* No new bDMARD is initiated at the time of sampling.
* Diagnosed with RA, PsA or AS.
* Starting treatment with infliximab or adalimumab.
* Co- treatment with csDMARD or glucocorticoid is acceptable.
* No new bDMARD is initiated at the time of sampling.
Exclusion Criteria
\-
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Aalborg University Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Karen Buch Lauridsen
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Lene Dreyer, MD, Prof.
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Medicine, Aalborg University and Aalborg University Hospital
Locations
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Department of rheumatology
Aalborg, , Denmark
Site Status
RECRUITING
Countries
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Denmark
Central Contacts
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References
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Other Identifiers
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N-20200063
Identifier Type: -
Identifier Source: org_study_id
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