Prediction of Treatment Response at 6 Months by Combinatorial Analysis of Serum Biomarkers in Biotherapy Naive SpA — PRESHUM  

Spondylitis, Ankylosing Clinical Trial

Official title: Prediction of Adalimumab Treatment Response at 6 Months by Combinatorial Analysis of Serum Biomarkers in Biotherapy Naive Spondyloarthritis: Pilot Study

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Spondylitis
• Spondylitis, Ankylosing

• NCT number: NCT03561649
• Study type: Interventional
• Source: University Hospital, Grenoble
• Status: Completed
• Phase: N/A
• Start date: June 14, 2018
• Completion date: May 7, 2020