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

NCT02687620 | Unknown

• 1 other identifier: KCU-12032014
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 13

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.

Conditions

Ankylosing Spondylitis; Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  every third months up to 104 weeks

• Bath Ankylosing Spondylitis Functional Index (BASFI)

  every third months up to 104 weeks

• Ankylosing Spondylitis Disease Activity Index (ASDAS)

  every third months (if available) up to 104 weeks

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Spondyloarthritis other than AS
• HIV positive or malignancy
• Being treated with another biological drug prior to study

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (13)

Cukurova University School of Medicine

Adana, Turkey (Türkiye)

Location

Ankara İbn-i Sina University School of Medicine

Ankara, Turkey (Türkiye)

Location

Gülhane Askeri Tıp Akademisi School of Medicine

Ankara, Turkey (Türkiye)

Location

Hacettepe University School of Medicine

Ankara, Turkey (Türkiye)

Location

Adnan Menderes University School of Medicine

Aydin, Turkey (Türkiye)

Location

Fırat University School of Medicine

Elâzığ, Turkey (Türkiye)

Location

Osman Gazi University School of Medicine

Eskişehir, Turkey (Türkiye)

Location

Goztepe Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa School of Medicine

Istanbul, Turkey (Türkiye)

Location

Istanbul University Istanbul School of Medicine

Istanbul, Turkey (Türkiye)

Location

Ege University School of Medicine

Izmir, Turkey (Türkiye)

Location

İzmir Katip Celebi University School of Medicine

Izmir, Turkey (Türkiye)

Location

Kocaeli University School of Medicine

Kocaeli, Turkey (Türkiye)

Location

Related Publications (20)

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• Glintborg B, Ostergaard M, Krogh NS, Dreyer L, Kristensen HL, Hetland ML. Predictors of treatment response and drug continuation in 842 patients with ankylosing spondylitis treated with anti-tumour necrosis factor: results from 8 years' surveillance in the Danish nationwide DANBIO registry. Ann Rheum Dis. 2010 Nov;69(11):2002-8. doi: 10.1136/ard.2009.124446. Epub 2010 May 28.

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Biospecimen

Retention: SAMPLES WITH DNA

During the serum sample aquisition whole blood samples with EDTA will be collected and stored.

MeSH Terms

Conditions

Spondylitis, Ankylosing; Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Servet Akar, Prof

  İzmir Katip Celebi University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 22, 2016
• Study Start: September 1, 2014
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (13)