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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
The selection of the biotherapy is carried out based on the recommendations of SinnoTest®. This test categorizes the bDMARDs based on the probability of response. It will allow to prescribe both original molecules, as well as biosimilars, in an equivalent way. In the SinnoTest® arm, the investigator prescribes the treatment defined as the most effective by SinnoTest®, except in case of contraindication. If contraindicated, the investigator prescribes the second-choice treatment (if any) of SinnoTest® in terms of efficacy.
The rheumatologist will use the current guidelines of rheumatoid arthritis to choose the more adapted biotherapy treatment to the patient
Hospital Universitario La Princesa
Madrid, Spain
ACTIVE_NOT_RECRUITINGHospital Universitario Ramon y Cajal
Madrid, Spain
RECRUITINGHospital Universitario Clinico San Carlos
Madrid, Spain
RECRUITINGHospital Universitario 12 de Octubre
Madrid, Spain
RECRUITINGHospital Universitario de La Paz
Madrid, Spain
RECRUITINGIncremental Cost Utility ratio at 6 months
This outcome will be calculated as the average differential cost per patient between both study arms (mean costs of the Sinnotest® Arm - mean costs of the Control Arm) divided by the diference in effectiveness between both study arms measured in the number of years of life weighted by the quality of life (QALY: quality-adjusted life year) generated by each of the strategies (mean QALY of the Sinnotest® Arm - mean QALY of the Control Arm). QALY will be measured using the EuroQol-5D. Cost will be considered from a Societal perspective, including both direct and indirect costs The ratio will be expressed in cost (2019 Euros) per QALY earned, which represents the additional cost that will have to be spent to earn a healthy year of life
Time frame: 6 months
Budget impact analysis at 6 and 12 months
A budget impact analysis will be carried out if the innovation is deemed efficient. This budget impact analysis will describe the resources consumed and the expenses generated by each scenario, a scenario with the use of SinnoTest® and a scenario without SinnoTest®.
Time frame: 12 months
Software's predictive model performance
Sensitivity, Especificity, positve and negative preddicted values of the predictive models using the biomarkers will be assessed on the new clinical data from the 6-month trial.
Time frame: 6 months
Description of the variation of the proteomic profile between M0 (biotherapy start date) and M6 (6 months visit)
Based on shotgun and semiquantitative proteomics, the diferences between the proteomic profile at baseline and at M6 will be analyzed
Time frame: Inclusion and 6 months
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