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Does Immunogenicity Have an Influence on the Efficacy of Anti-TNF Therapy in Patients With AS: An Inception Cohort Study

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ClinicalTrials.gov Identifier: NCT02687620
Recruitment Status : Active, not recruiting
First Posted : February 22, 2016
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Servet Akar, Izmir Katip Celebi University

Brief Summary:
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.

Condition or disease
Ankylosing Spondylitis Axial Spondyloarthritis

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Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : September 2014
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Group/Cohort
AS patients receiving Anti-TNF treatment
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 Outcome Measures :
  1. Serum drug levels [ Time Frame: 0, 3, 6 12 and 24 months of the study ]
    It will be measured in mg/L or other measurement levels by using ELISA

  2. Anti-drug antibody levels [ Time Frame: 0, 3, 6 12 and 24 months of the study ]
    It will be measured in AU/mL or other measurement levels by using ELISA


Secondary Outcome Measures :
  1. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: every third months up to 104 weeks ]
    In order to evaluate function BASDAI will be evaluated in numeric rating scale (0-10)

  2. Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: every third months up to 104 weeks ]
    In order to evaluate function BASFI will be evaluated in numeric rating scale (0-10)

  3. Ankylosing Spondylitis Disease Activity Index (ASDAS) [ Time Frame: every third months (if available) up to 104 weeks ]

    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)



Biospecimen Retention:   Samples With DNA
During the serum sample aquisition whole blood samples with EDTA will be collected and stored.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Three hundred and fifty consecutive AS patients fulfilling the modified New York criteria for the classification of AS, 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687620


Locations
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Turkey
Cukurova University School of Medicine
Adana, Turkey
Ankara İbn-i Sina University School of Medicine
Ankara, Turkey
Gülhane Askeri Tıp Akademisi School of Medicine
Ankara, Turkey
Hacettepe University School of Medicine
Ankara, Turkey
Adnan Menderes University School of Medicine
Aydın, Turkey
Fırat 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
İzmir, Turkey
İzmir Katip Celebi University School of Medicine
İzmir, Turkey
Kocaeli University School of Medicine
Kocaeli, Turkey
Sponsors and Collaborators
Izmir Katip Celebi University
Investigators
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Principal Investigator: Servet Akar, Prof İzmir Katip Celebi University School of Medicine
Publications:

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Responsible Party: Dr. Servet Akar, Prof, Izmir Katip Celebi University
ClinicalTrials.gov Identifier: NCT02687620    
Other Study ID Numbers: KCU-12032014
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Ankylosis
Joint Diseases
Arthritis