Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04731831
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2020-12-19
Brief Title:
Characterization of Immunogenicity of TNF Inhibitors in Arthritis Patients With Poorer Treatment Response
Sponsor:
Aalborg University Hospital
Organization:
Aalborg University Hospital
Study Overview
Official Title:
Characterization of Immunogenicity of Tumor Necrosis Factor Inhibitors in Arthritis Patients With Poorer Treatment Response Due to Gender Obesity and Smoking Status
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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:
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
Detailed Description:
Tumor necrosis factor inhibitors TNFIs have been uses with success since 1999 in Denmark in treatment of various inflammatory diseases eg rheumatoid arthritis RA Chrohns 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 antibodiesADA
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 antibodiesADA
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None