Prediction of Treatment Response at 6 Months by Combinatorial Analysis of Serum Biomarkers in Biotherapy Naive SpA
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylitis, Ankylosing
Study type: Interventional

Summary: 
      The main objective of this trial is to search for biomarkers associated with the success of
      adalimumab treatment in order to generate an algorithm to predict the response to this
      treatment at 6 months in spondyloarthritis and to define its metrological properties on this
      cohort.

      The algorithm will allow to better target patients who will have an important benefit/risk
      ratio for adalimumab treatment.
    

Detailed description: 
      The general prevalence of spondyloarthritis (SpA) is 0.5% of the Caucasian population and
      that of ankylosing spondylitis (AS) is 0.3% in France.

      First-line treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) is insufficiently
      effective in more than half of AS patients in hospitals. These patients are then treated with
      "anti-tumor necrosis factor alpha" (anti-TNFα). The use of these bio-drugs increasing each
      year, they become a significant public health and economic challenge. Their development is
      just beginning, because they are among the largest providers of pharmacy innovations.

      The two main cost-drivers appear to be, on the most advanced forms of inflammatory
      rheumatism, the use of appropriate care structures or services and surgery, especially knee
      and hip surgery. Among patients treated with biotherapy, clinical practice shows that about
      one-third (33%) will not respond to selected biopharmaceuticals as these biologics are often
      prescribed empirically, mainly because of the lack of criteria based on scientific evidence
      and availability of tools able to predict the response or non-response to these molecules.

      Until now, there is no algorithm which can predict the response to biotherapies like
      adalimumab. The aim of this trial is to search for biomarkers associated with the success of
      adalimumab treatment in order to generate an algorithm predicting the response to this
      treatment at 6 months for patients with SpA. This algorithm will be set up from patients'
      biological and clinical data available after 6 months of adalimumab treatment. A number of 50
      patients seems to be statistically sufficient to assess the probability of response or non
      response to adalimumab in SA with the defined algorithm. A logistic regression model will be
      used by incorporating the set of available variables.

      Then it will be necessary to set up a validation study to determine the metrological
      properties of the algorithm on an independent cohort.
    

Intervention name(s): Adalimumab
Intervention type(s): Drug
Intervention description(s): This trial will be conducted by rheumatologists who can follow patients with SpA and conduct this trial in good conditions and in accordance with regulatory and legal recommendations.
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: TNF inhibitor; Adalimumab; Spondyloarthritis; Biomarkers analysis; Personalized medicine