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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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.

Detailed Summary:

Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease that predominantly affects sacroiliac joints and spine. It is the prototype of spondyloarthritides (SpA) and one of the most common rheumatic diseases. Sacroiliitis is the earliest manifestation of disease and accompanying with spinal involvement cause inflammatory back pain (IBP). IBP usually starts insidiously in the early adulthood and typically it is felt deep in the buttock and/or lower lumbar regions. It improves with activity and returns with the rest and is usually accompanied by morning stiffness lasting at least 30 minutes. Involvement of the spine in patients with AS is usually not limited to the sacroiliac joints and lumbar region and usually it extends up to the thoracic and cervical segment. Currently the only sign that is diagnostic for AS is radiographic sacroiliitis. However radiography detects structural changes and take up to ten years to appear unequivocally.

In some patients bone tenderness due to enthesitis may be the primary complaint. Arthritis in the hips and shoulders occur in some patients and is associated with worse prognosis. Typical arthritis pattern in AS patients is asymmetric and usually involves the lower extremity joints. There are several extra-articular features of AS and the most common is acute anterior uveitis.

Until recently treatment options for AS were limited and based on non-steroidal anti-inflammatory drugs (NSAIDs), traditional disease modifying anti-rheumatic drugs (DMARDs) for the rheumatoid arthritis and physical therapy. The last decade witnessed a major advance in AS therapy with the use of anti-tumor necrosis factor (anti-TNF) agents. Anti-TNF agents have a substantial effect not only the axial disease but also in peripheral arthritis, enthesitis and extra-articular features (like psoriasis and infl
Sponsor: Izmir Katip Celebi University

Current Primary Outcome:

  • 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
  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)
  • 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)
  • 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)



Original Secondary Outcome: Same as current

Information By: Izmir Katip Celebi University

Dates:
Date Received: February 3, 2016
Date Started: September 2014
Date Completion: September 2018
Last Updated: September 18, 2016
Last Verified: September 2016