Arthritis, Rheumatoid Clinical Trial
Official title:
PRediction mEdical DevIce for Rheumatoid Arthritis: Scale-up of Unique Predictive Online Platform Highly Improving the Quality of Life of Rheumatoid Arthritis' Patient by Personalised and Efficient Biotherapies Prescription
Rheumatoid arthritis (RA) is one of the leading chronic inflammatory rheumatism, with a
prevalence of about 0.4% of the population.
First-line therapy with synthetic disease modifying anti-rheumatic drugs (including
methotrexate) is insufficiently effective in 40% of cases. These patients are then treated
with biotherapies. The use of these bio-drugs increases each year, becoming a public health
issue and a considerable economic burden. Besides, their growth is just beginning, as they
are among the major purveyors of pharmacy innovations.
There are about ten bio-drugs currently on the market for rheumatoid arthritis with an
average annual treatment cost of 8 to 12 K € per patient. This cost is 20 times higher than
that of synthetic disease modifying anti-rheumatic drugs. However, among patients treated
with biotherapies, clinical practice shows that about one-third will not respond to the
selected drug. In the case of non-response, practitioners currently have no choice but to
perform an empirical rotation between the different treatments, because no tool capable of
predicting the response or non-response to these molecules is currently available.
The study is a prospective, phase III, controlled, multicenter, and randomized, single-blind
(patient) clinical trial.
- Intervention arm: Prescription of biotherapy (rituximab, adalimumab, abatacept) using
SinnoTest® software
- Control arm: Prescription of biotherapy without the SinnoTest® software which
corresponds to current practice (all biotherapies).
In addition, a sub study will be carried out within this trial to analyse the proteomic
profile of the patients included and their modification throughout the study.
To study the clinical and pharmacoeconomic impact after 6 months of the use of the SinnoTest®
predictive tool in patients with rheumatoid arthritis who have failed to a first anti-TNF
biologic agent compared to usual care.
n/a
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