Clinical trial · Observational
Characterization of Immunogenicity of TNF Inhibitors in Arthritis Patients With Poorer Treatment Response.
Characterization of Immunogenicity of Tumor Necrosis Factor Inhibitors in Arthritis Patients With Poorer Treatment Response Due to Gender, Obesity and Smoking Status.
NCT04731831CI-TRIAL-00078366unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arthritis, Psoriatic | — | UNRESOLVED | — |
| Arthritis, Rheumatoid | — | UNRESOLVED | — |
| Spondylitis, Ankylosing | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patient with arthritis starting infliximab or adalimumab
- description
- Patients with Rheumatoid Artritis, Psoriatic Arthritis, Anchylosing Spondylitis starting treament with infliximab or adalimumab
Primary outcomes (1)
- measure
- Treatment response
- timeFrame
- 12 months
- description
- Changes in disease activity score according to the diagnose. A reduction in the disease activity score indicates a good treatment response. * Disease Activity Score 28 joints with C-reactive protein (DAS28-CRP) * Disease Activity in Psoriasis Arthritis (DAPSA) * Ankylosing Spondylitis Activity Score (ASDAS) * Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) * Bath Ankylosin Spondylitis Functional Index (BASFI)
Secondary outcomes (5)
- measure
- Immunogenesity
- timeFrame
- 12 months
- description
- Antibodies directed against infliximab or adalimumab. Concentration of anti-drug-antibodies
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: \-
References
Publications (29)
- BACKGROUNDTracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther. 2008 Feb;117(2):244-79. doi: 10.1016/j.pharmthera.2007.10.001. Epub 2007 Oct 26. PMID 18155297
- BACKGROUNDElliott MJ, Maini RN, Feldmann M, Kalden JR, Antoni C, Smolen JS, Leeb B, Breedveld FC, Macfarlane JD, Bijl H, et al. Randomised double-blind comparison of chimeric monoclonal antibody to tumour necrosis factor alpha (cA2) versus placebo in rheumatoid arthritis. Lancet. 1994 Oct 22;344(8930):1105-10. doi: 10.1016/s0140-6736(94)90628-9. PMID 7934491
- BACKGROUNDSteenholdt C, Bendtzen K, Brynskov J, Ainsworth MA. Optimizing Treatment with TNF Inhibitors in Inflammatory Bowel Disease by Monitoring Drug Levels and Antidrug Antibodies. Inflamm Bowel Dis. 2016 Aug;22(8):1999-2015. doi: 10.1097/MIB.0000000000000772. PMID 27135483
- BACKGROUNDvan Schie KA, Hart MH, de Groot ER, Kruithof S, Aarden LA, Wolbink GJ, Rispens T. The antibody response against human and chimeric anti-TNF therapeutic antibodies primarily targets the TNF binding region. Ann Rheum Dis. 2015 Jan;74(1):311-4. doi: 10.1136/annrheumdis-2014-206237. Epub 2014 Oct 23. PMID 25342759
- BACKGROUNDKalden JR, Schulze-Koops H. Immunogenicity and loss of response to TNF inhibitors: implications for rheumatoid arthritis treatment. Nat Rev Rheumatol. 2017 Nov 21;13(12):707-718. doi: 10.1038/nrrheum.2017.187. PMID 29158574
- BACKGROUNDMeroni PL, Valentini G, Ayala F, Cattaneo A, Valesini G. New strategies to address the pharmacodynamics and pharmacokinetics of tumor necrosis factor (TNF) inhibitors: A systematic analysis. Autoimmun Rev. 2015 Sep;14(9):812-29. doi: 10.1016/j.autrev.2015.05.001. Epub 2015 May 15. PMID 25985765
- BACKGROUNDMould DR. The Pharmacokinetics of Biologics: A Primer. Dig Dis. 2015;33 Suppl 1:61-69. doi: 10.1159/000437077. Epub 2015 Sep 14.