NCT04147026: PREDIRA

Prediction Medical Device for Rheumatoid Arthritis (PREDIRA)

Status unknown NA Last updated 9 January 2020

What this trial tests

NA trial testing SinnoTest® in Arthritis, Rheumatoid in 180 participants. Status unknown.

Timeline

16 December 2019

Primary endpoint
1 July 2020

1 January 2021

Quick facts

Lead sponsor	Hospital San Carlos, Madrid
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	180
Start date	16 December 2019
Primary completion	1 July 2020
Estimated completion	1 January 2021
Sites	5 locations across Spain

Drugs / interventions tested

• SinnoTest®
• Biotherapy prescription without SinnoTest® software

Conditions studied

• Arthritis, Rheumatoid — all drugs for Arthritis, Rheumatoid →

Sponsor

Hospital San Carlos, Madrid

Who can join

Adults 18 to 70, any sex, with Arthritis, Rheumatoid. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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).
   Freites-Núñez D, Baillet A, Rodriguez-Rodriguez L, Nguyen MVC, et al · · 2020 · cited 5× · PMID 32867830 · DOI 10.1186/s13063-020-04683-7
2. PREDIRA (PRediction mEdical DevIce for Rheumatoid Arthritis): Scale-up of unique predictive online platform highly improving the quality of life of Rheumatoid Arthritis’ patient by personalized and efficient biotherapies prescription
   Nuñez DF, Baillet A, Rodriguez-Rodriguez L, Nguyen MVC, et al · · 2020 · DOI 10.21203/rs.2.24691/v1