Prediction Medical Device for Rheumatoid Arthritis (PREDIRA)
NCT ID: NCT04147026
Last Updated: 2020-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2019-12-16
2021-01-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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).
TREATMENT
DOUBLE
Study Groups
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SinnoTest® software
SinnoTest® is a therapeutic guidance device for patients suffering from rheumatoid arthritis. Prescription of an original or biosimilar biotherapy (rituximab, adalimumab, abatacept) is possible.
SinnoTest®
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.
Current practice
Prescription of biotherapy without the SinnoTest® software which corresponds to current practice (all biotherapies).
Biotherapy prescription without SinnoTest® software
The rheumatologist will use the current guidelines of rheumatoid arthritis to choose the more adapted biotherapy treatment to the patient
Interventions
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SinnoTest®
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.
Biotherapy prescription without SinnoTest® software
The rheumatologist will use the current guidelines of rheumatoid arthritis to choose the more adapted biotherapy treatment to the patient
Eligibility Criteria
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Inclusion Criteria
* Patients with RA, defined according to the ACR / EULAR 2010 or ACR 1987 criteria,
* Patients failing a first anti-TNF, defined as:
* Ineffectiveness (which is defined as a DAS28-ESR ≥3.2 and an inadequate response to iTNF according to the usual rheumatologist, which generally includes one or more of the following conditions: persistent swollen and tender joints, persistence of disease activity according to the overall evaluation of the patient, high levels of acute phase reactants and/or dependence of analgesics, nonsteroidal anti-inflammatory drugs or corticosteroids); or
* Toxicity(defined as the appearance of any adverse event that the patient's rheumatologist relates to the medication and requires discontinuation),
* Effective contraception for patients of childbearing potential (oral contraceptive, intrauterine device, implant, spermicide, surgical sterilization or abstinence),
* Patients able to read and understand the modalities of the protocol,
* Patients who have dated and signed the informed consent form of the trial,
* Stability of treatments (no change) between the selection visit and the inclusion visit (M0).
Exclusion Criteria
* Patients included in another therapeutic evaluation study during this trial,
* Surgical intervention programmed during the trial,
* Patients with difficulties in understanding the Spanish language,
* Patients cannot be followed up 6 months,
* Psychosocial instability incompatible with regular monitoring (homelessness, addictive behaviour, antecedent of psychiatric pathology or any other comorbidity that would make it impossible for free and informed consent or limit adherence to the protocol),
* Breastfeeding and/or pregnancy. Although there are bDMARD that can be used in pregnancy, since SinnoTest can recommend one that discourages this condition, it is decided to exclude the inclusion of pregnant women.
18 Years
70 Years
ALL
No
Sponsors
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Hospital San Carlos, Madrid
OTHER
Responsible Party
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Benjamin Fernandez Gutierrez
Principal Investigator
Principal Investigators
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Benjamín Fernández-Gutiérrez, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital San Carlos, Madrid
Locations
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Hospital Universitario La Princesa
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario de La Paz
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Mónica Vázquez-Díaz, MD, PhD
Role: primary
José Luis Pablos Álvarez, MD, PhD
Role: primary
Alejandro Balsa Criado, MD, PhD
Role: primary
References
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Nguyen MVC, Baillet A, Romand X, Trocme C, Courtier A, Marotte H, Thomas T, Soubrier M, Miossec P, Tebib J, Grange L, Toussaint B, Lequerre T, Vittecoq O, Gaudin P. Prealbumin, platelet factor 4 and S100A12 combination at baseline predicts good response to TNF alpha inhibitors in rheumatoid arthritis. Joint Bone Spine. 2019 Mar;86(2):195-201. doi: 10.1016/j.jbspin.2018.05.006. Epub 2018 Jun 6.
Nguyen MVC, Adrait A, Baillet A, Trocme C, Gottenberg JE, Gaudin P. Identification of cartilage oligomeric matrix protein as biomarker predicting abatacept response in rheumatoid arthritis patients with insufficient response to a first anti-TNFalpha treatment. Joint Bone Spine. 2019 May;86(3):401-403. doi: 10.1016/j.jbspin.2018.09.005. Epub 2018 Sep 19. No abstract available.
Baillet A, Trocme C, Romand X, Nguyen CMV, Courtier A, Toussaint B, Gaudin P, Epaulard O. Calprotectin discriminates septic arthritis from pseudogout and rheumatoid arthritis. Rheumatology (Oxford). 2019 Sep 1;58(9):1644-1648. doi: 10.1093/rheumatology/kez098.
Baillet A, Trocme C, Berthier S, Arlotto M, Grange L, Chenau J, Quetant S, Seve M, Berger F, Juvin R, Morel F, Gaudin P. Synovial fluid proteomic fingerprint: S100A8, S100A9 and S100A12 proteins discriminate rheumatoid arthritis from other inflammatory joint diseases. Rheumatology (Oxford). 2010 Apr;49(4):671-82. doi: 10.1093/rheumatology/kep452. Epub 2010 Jan 25.
Trocme C, Marotte H, Baillet A, Pallot-Prades B, Garin J, Grange L, Miossec P, Tebib J, Berger F, Nissen MJ, Juvin R, Morel F, Gaudin P. Apolipoprotein A-I and platelet factor 4 are biomarkers for infliximab response in rheumatoid arthritis. Ann Rheum Dis. 2009 Aug;68(8):1328-33. doi: 10.1136/ard.2008.093153. Epub 2008 Jul 29.
Freites-Nunez D, Baillet A, Rodriguez-Rodriguez L, Nguyen MVC, Gonzalez I, Pablos JL, Balsa A, Vazquez M, Gaudin P, Fernandez-Gutierrez B. 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). Trials. 2020 Aug 31;21(1):755. doi: 10.1186/s13063-020-04683-7.
Other Identifiers
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EUR.PREDIRA
Identifier Type: -
Identifier Source: org_study_id
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