Ankylosing Spondylitis Clinical Trial
Official title:
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
Verified date | February 2021 |
Source | Izmir Katip Celebi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 180 |
Est. completion date | April 2021 |
Est. primary completion date | April 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Cukurova University School of Medicine | Adana | |
Turkey | Ankara Ibn-i Sina University School of Medicine | Ankara | |
Turkey | Gülhane Askeri Tip Akademisi School of Medicine | Ankara | |
Turkey | Hacettepe University School of Medicine | Ankara | |
Turkey | Adnan Menderes University School of Medicine | Aydin | |
Turkey | Firat University School of Medicine | Elazig | |
Turkey | Osman Gazi University School of Medicine | Eskisehir | |
Turkey | Goztepe Training and Research Hospital | Istanbul | |
Turkey | Istanbul University Cerrahpasa School of Medicine | Istanbul | |
Turkey | Istanbul University Istanbul School of Medicine | Istanbul | |
Turkey | Ege University School of Medicine | Izmir | |
Turkey | Izmir Katip Celebi University School of Medicine | Izmir | |
Turkey | Kocaeli University School of Medicine | Kocaeli |
Lead Sponsor | Collaborator |
---|---|
Izmir Katip Celebi University |
Turkey,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum drug levels | It will be measured in mg/L or other measurement levels by using ELISA | 0, 3, 6 12 and 24 months of the study | |
Primary | Anti-drug antibody levels | It will be measured in AU/mL or other measurement levels by using ELISA | 0, 3, 6 12 and 24 months of the study | |
Secondary | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | In order to evaluate function BASDAI will be evaluated in numeric rating scale (0-10) | every third months up to 104 weeks | |
Secondary | Bath Ankylosing Spondylitis Functional Index (BASFI) | In order to evaluate function BASFI will be evaluated in numeric rating scale (0-10) | every third months up to 104 weeks | |
Secondary | Ankylosing Spondylitis Disease Activity Index (ASDAS) | ASDAS-CRP (the preferred version) will be calculated by using the following formula:
0.12 X Back pain + 0.06 X Duration of morning stiffness + 0.11 X Patient global + 0.07 X Peripheral pain / swelling + 0.58 X Ln (CRP + 1) |
every third months (if available) up to 104 weeks |
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