Efficacy, safety and cost-effectiveness of a web-based platform delivering the results of a biomarker-based predictive model of biotherapy response for rheumatoid arthritis patients: a protocol for a randomized multicenter single-blind active controlled clinical trial (PREDIRA).
Antirheumatic Agents
/ adverse effects
Arthritis, Rheumatoid
/ diagnosis
Biological Therapy
Biomarkers
Cost-Benefit Analysis
Humans
Internet
Multicenter Studies as Topic
Prospective Studies
Proteomics
Randomized Controlled Trials as Topic
Single-Blind Method
Treatment Outcome
Tumor Necrosis Factor Inhibitors
Anti-TNFα agents
Personalized medicine
Prediction models
Rheumatoid arthritis
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
31 Aug 2020
31 Aug 2020
Historique:
received:
30
01
2020
accepted:
14
08
2020
entrez:
2
9
2020
pubmed:
2
9
2020
medline:
22
6
2021
Statut:
epublish
Résumé
Rheumatoid arthritis (RA) is one of the leading chronic inflammatory rheumatism. First-line therapy with synthetic disease-modifying antirheumatic drugs (sDMARD) is insufficiently effective in 40% of cases and these patients are treated with biotherapies. The increased use of these drugs each year is becoming a public health issue with considerable economic burden. This cost is 20 times higher than that of sDMARD. However, among patients treated with biotherapies, clinical practice shows that about one third will not respond to the selected drug. In nonresponse cases, practitioners currently have no choice but to perform an empirical switching between different treatments, because no tool capable of predicting the response or nonresponse to these molecules is currently available. The study is a prospective, phase III, controlled, multicenter, and randomized, single-blind (patient) clinical trial, including RA patients with a previous failure to anti-TNF therapies. The main objective is the analysis of the clinical and pharmacoeconomic impact after 6 months of treatment. Intervention arm: prescription of biotherapy (rituximab, adalimumab, abatacept) using SinnoTest® software, a prediction software based on proteomic biomarkers. Control arm: prescription of biotherapy based on current practice, without the SinnoTest® software (any biotherapy). In addition, a substudy will be carried out within this trial to generate a biobank and further analyze the proteomic profile of the patients and their modification throughout the study. This clinical trial study will be the first validation study of a biotherapy response prediction software, bringing personalized medicine into the management of RA. We expect that the findings from this study will bring several benefits for the patient and the Health Care System. ClincalTrials.gov NCT04147026 . Registered on 31 October, 2019.
Sections du résumé
BACKGROUND
BACKGROUND
Rheumatoid arthritis (RA) is one of the leading chronic inflammatory rheumatism. First-line therapy with synthetic disease-modifying antirheumatic drugs (sDMARD) is insufficiently effective in 40% of cases and these patients are treated with biotherapies. The increased use of these drugs each year is becoming a public health issue with considerable economic burden. This cost is 20 times higher than that of sDMARD. However, among patients treated with biotherapies, clinical practice shows that about one third will not respond to the selected drug. In nonresponse cases, practitioners currently have no choice but to perform an empirical switching between different treatments, because no tool capable of predicting the response or nonresponse to these molecules is currently available.
METHODS
METHODS
The study is a prospective, phase III, controlled, multicenter, and randomized, single-blind (patient) clinical trial, including RA patients with a previous failure to anti-TNF therapies. The main objective is the analysis of the clinical and pharmacoeconomic impact after 6 months of treatment. Intervention arm: prescription of biotherapy (rituximab, adalimumab, abatacept) using SinnoTest® software, a prediction software based on proteomic biomarkers. Control arm: prescription of biotherapy based on current practice, without the SinnoTest® software (any biotherapy). In addition, a substudy will be carried out within this trial to generate a biobank and further analyze the proteomic profile of the patients and their modification throughout the study.
DISCUSSION
CONCLUSIONS
This clinical trial study will be the first validation study of a biotherapy response prediction software, bringing personalized medicine into the management of RA. We expect that the findings from this study will bring several benefits for the patient and the Health Care System.
TRIAL REGISTRATION
BACKGROUND
ClincalTrials.gov NCT04147026 . Registered on 31 October, 2019.
Identifiants
pubmed: 32867830
doi: 10.1186/s13063-020-04683-7
pii: 10.1186/s13063-020-04683-7
pmc: PMC7456748
doi:
Substances chimiques
Antirheumatic Agents
0
Biomarkers
0
Tumor Necrosis Factor Inhibitors
0
Banques de données
ClinicalTrials.gov
['NCT04147026']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
755Subventions
Organisme : EIT Health
ID : 19577
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