Tumor necrosis factor antagonist mechanisms of action: a comprehensive review.
Daniel Tracey, Lars Klareskog, Eric H Sasso...
https://pubmed.ncbi.nlm.nih.gov/18155297Actively Recruiting
Age: 18Years +
All Genders
ID04731831
Characterization of Immunogenicity of Tumor Necrosis Factor Inhibitors in Arthritis Patients With Poorer Treatment Response Due to Gender, Obesity and Smoking Status
Led by Aalborg University Hospital · Updated on 2024-06-28
120
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying arthritis patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis who start treatment with tumor necrosis factor inhibitors (TNFIs) like adalimumab or infliximab. The study aims to understand how gender, smoking, and obesity affect treatment response by examining inflammation, immune markers, drug levels, and antibodies against the drugs. This observational study hopes to identify reasons behind poorer treatment responses in certain patient groups to help personalize therapy. Participants will be followed for 12 months while receiving their prescribed TNFI treatments. Blood samples will be collected at baseline, 2, 4, and 12 months or when treatment ends. The study will measure genotypes, autoantibodies, inflammation markers, drug concentrations, and anti-drug antibodies to assess immune responses and drug behavior. Patient data will be registered in the DANBIO database as part of routine care. During the study, participants will have blood tests and be monitored for treatment response and immune markers. Researchers will analyze the presence of inflammation, autoantibodies, HLA type, and drug-related antibodies over time. The main outcome is treatment response after 12 months. Safety and adherence to treatment will also be recorded. The total participation length is one year with periodic assessments throughout this time.
CONDITIONS
Brief Title
Characterization of Immunogenicity of TNF Inhibitors in Arthritis Patients With Poorer Treatment Response.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old
- Diagnosed with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
- Starting treatment with infliximab or adalimumab
- Co-treatment with conventional synthetic disease-modifying antirheumatic drugs or glucocorticoids is allowed
- No new biological disease-modifying drugs started at the time of sampling
You will not qualify if you...
- None specified in the criteria provided for this study or no additional exclusion criteria beyond those implied by inclusion requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Monitoring
Duration - 12 months
Participants starting treatment with infliximab or adalimumab are followed to assess treatment response and immunogenicity over 12 months.
Visits at baseline, 2, 4, and 12 months or at treatment termination for blood sample collection
Trial Site Locations
Total: 1 location
1
Department of rheumatology
Aalborg, Denmark, 8000
Actively Recruiting
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Research Team
K
Karen B Lauridsen, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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M J Elliott, R N Maini, M Feldmann...
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K A van Schie, M H Hart, E R de Groot...
https://pubmed.ncbi.nlm.nih.gov/25342759Immunogenicity and loss of response to TNF inhibitors: implications for rheumatoid arthritis treatment.
Joachim R Kalden, Hendrik Schulze-Koops
https://pubmed.ncbi.nlm.nih.gov/29158574New strategies to address the pharmacodynamics and pharmacokinetics of tumor necrosis factor (TNF) inhibitors: A systematic analysis.
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Pil Højgaard, Christine Ballegaard, René Cordtz...
https://pubmed.ncbi.nlm.nih.gov/29893926A 2-year observational study on treatment targets in psoriatic arthritis patients treated with TNF inhibitors.
Maria Sole Chimenti, Paola Triggianese, Paola Conigliaro...
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