Exploring how gender, smoking, and obesity affect TNF inhibitor treatment in arthritis patients
Characterization of Immunogenicity of Tumor Necrosis Factor Inhibitors in Arthritis Patients With Poorer Treatment Response Due to Gender, Obesity and Smoking Status.
This study is trying to see how gender, smoking, and obesity affect how well arthritis patients respond to a specific type of treatment called TNF inhibitors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aalborg University Hospital Academic / other |
| Drugs / interventions | infliximab, adalimumab |
| Locations | 1 site (Aalborg) |
| Trial ID | NCT04731831 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the factors influencing the treatment response to tumor necrosis factor inhibitors (TNFIs) in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It will focus on how gender, tobacco smoking, and obesity may correlate with treatment outcomes, potentially due to variations in inflammation levels, human leucocyte antigen (HLA) types, autoantibodies, and the presence of anti-drug antibodies (ADA). A total of 120 patients will be followed for 12 months, with blood samples collected at multiple time points to analyze various biomarkers. The findings could help clarify why certain patient groups respond poorly to TNFIs.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis who are starting treatment with infliximab or adalimumab.
Not a fit: Patients who are not initiating treatment with TNF inhibitors or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for arthritis patients, improving their response to TNF inhibitors.
How similar studies have performed: While the specific focus on gender, smoking, and obesity in relation to TNFIs is novel, previous studies have indicated that immunogenicity can affect treatment responses in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Exclusion Criteria: \-
Where this trial is running
Aalborg
- Department of rheumatology — Aalborg, Denmark (Recruiting)
Study contacts
- Principal investigator: Lene Dreyer, MD, Prof. — Department of Clinical Medicine, Aalborg University and Aalborg University Hospital
- Study coordinator: Karen B Lauridsen, MD
- Email: kabula@rn.dk
- Phone: 0045 097665595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.