Clinical trial · Observational
Does Immunogenicity Have an Influence on the Efficacy of Anti-TNF Therapy in Patients With AS: An Inception Cohort Study
Does Immunogenicity Have an Influence on the Efficacy of Anti-tumor Necrosis Factor (Anti-TNF) Therapy in Patients With Ankylosing Spondylitis (AS): An Inception Cohort Study
- 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 purpose of this prospective cohort study is to evaluate the influence of serum drug levels and development of anti-drug antibodies on clinical response to anti-TNF agents in ankylosing spondylitis(AS) treatment. Secondary aims are to assess the demographic, clinical and laboratory variables associated with the development of anti-TNF drug antibodies at baseline or disease course and to reveal the impact of anti-drug antibodies on long-term efficacy or safety in particular drug survival in AS patients treated in daily clinical practice.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ankylosing Spondylitis | — | UNRESOLVED | — |
| Axial Spondyloarthritis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- AS patients receiving Anti-TNF treatment
- description
- Three hundred and fifty consecutive AS patients fulfilling the modified New York criteria for the classification of AS (5), and with a new anti-TNF agent prescription (either for the first time or switched) in the last two weeks period will be included. Treatment with anti-TNF agents will be in accordance with the regulations of Turkish Social Security Agency (SGK) on the initiation and continuation of anti-TNF agents in AS, as well as ASAS/EULAR recommendations for the management of AS (29, 30).
Primary outcomes (2)
- measure
- Serum drug levels
- timeFrame
- 0, 3, 6 12 and 24 months of the study
- description
- It will be measured in mg/L or other measurement levels by using ELISA
- measure
- Anti-drug antibody levels
- timeFrame
- 0, 3, 6 12 and 24 months of the study
- description
- It will be measured in AU/mL or other measurement levels by using ELISA
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients whom are receiving their first anti-TNF treatment(not switch) * Ankylosing spondylitis diagnosis according to modified New York Criteria * Patients whom were older than 18 years old on anti-TNF initiation Exclusion Criteria: * Spondyloarthritis other than AS * HIV positive or malignancy * Being treated with another biological drug prior to study
References
Publications (20)
- BACKGROUNDBraun J, Bollow M, Remlinger G, Eggens U, Rudwaleit M, Distler A, Sieper J. Prevalence of spondylarthropathies in HLA-B27 positive and negative blood donors. Arthritis Rheum. 1998 Jan;41(1):58-67. doi: 10.1002/1529-0131(199801)41:13.0.CO;2-G. PMID 9433870
- BACKGROUNDOnen F, Akar S, Birlik M, Sari I, Khan MA, Gurler O, Ergor A, Manisali M, Akkoc N. Prevalence of ankylosing spondylitis and related spondyloarthritides in an urban area of Izmir, Turkey. J Rheumatol. 2008 Feb;35(2):305-9. Epub 2007 Dec 15. PMID 18085733
- BACKGROUNDSieper J, Braun J, Rudwaleit M, Boonen A, Zink A. Ankylosing spondylitis: an overview. Ann Rheum Dis. 2002 Dec;61 Suppl 3(Suppl 3):iii8-18. doi: 10.1136/ard.61.suppl_3.iii8. PMID 12381506
- BACKGROUNDBurgos-Vargas R, Braun J. Inflammatory back pain. Rheum Dis Clin North Am. 2012 Aug;38(3):487-99. doi: 10.1016/j.rdc.2012.08.014. Epub 2012 Sep 14. PMID 23083750
- BACKGROUNDvan der Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum. 1984 Apr;27(4):361-8. doi: 10.1002/art.1780270401. PMID 6231933
- BACKGROUNDFeldtkeller E, Khan MA, van der Heijde D, van der Linden S, Braun J. Age at disease onset and diagnosis delay in HLA-B27 negative vs. positive patients with ankylosing spondylitis. Rheumatol Int. 2003 Mar;23(2):61-6. doi: 10.1007/s00296-002-0237-4. Epub 2002 Sep 3. PMID 12634937
- BACKGROUNDMau W, Zeidler H, Mau R, Majewski A, Freyschmidt J, Stangel W, Deicher H. Clinical features and prognosis of patients with possible ankylosing spondylitis. Results of a 10-year followup. J Rheumatol. 1988 Jul;15(7):1109-14. PMID 3262757