Prediction Medical Device for Rheumatoid Arthritis (PREDIRA)

NCT04147026 | Unknown

• 1 other identifier: EUR.PREDIRA
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Arthritis, Rheumatoid

Keywords

Biological therapy; Predictive software; Quality of life

Outcome Measures

Primary Outcomes (1)

• Incremental 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

  6 months

Secondary Outcomes (3)

• Budget impact analysis at 6 and 12 months

  12 months

• Software's predictive model performance

  6 months

• Description of the variation of the proteomic profile between M0 (biotherapy start date) and M6 (6 months visit)

  Inclusion and 6 months

Other Outcomes (1)

• Incremental Cost Effectiveness ratio at 6 months

  6 months

Study Arms (2)

SinnoTest® software

EXPERIMENTAL

SinnoTest® is a therapeutic guidance device for patients suffering from rheumatoid arthritis. Prescription of an original or biosimilar biotherapy (rituximab, adalimumab, abatacept) is possible.

Device: SinnoTest®

Current practice

ACTIVE COMPARATOR

Prescription of biotherapy without the SinnoTest® software which corresponds to current practice (all biotherapies).

Other: Biotherapy prescription without SinnoTest® software

Interventions

SinnoTest® DEVICE

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.

SinnoTest® software

Biotherapy prescription without SinnoTest® software OTHER

The rheumatologist will use the current guidelines of rheumatoid arthritis to choose the more adapted biotherapy treatment to the patient

Current practice

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old and under 70 years old,
• 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,

You may not qualify if:

• Patients with a contraindication to any bDMARD or methotrexate,
• 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),

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (5)

Hospital Universitario La Princesa

Madrid, 28006, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario de La Paz

Madrid, 28046, Spain

RECRUITING

Related Publications (6)

• 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.

  PMID: 29885551 BACKGROUND

• 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.

  PMID: 30243783 BACKGROUND

• 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.

  PMID: 30919904 BACKGROUND

• 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.

  PMID: 20100792 BACKGROUND

• 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.

  PMID: 18664547 BACKGROUND

• 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.

  PMID: 32867830 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Benjamín Fernández-Gutiérrez, MD, PhD

  Hospital San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Rodriguez-Rodriguez, MD, PhD

CONTACT

+34913303615; lrrodriguez@salud.madrid.org

Dalifer Freites Nuñez, MD

CONTACT

+34913303615; daliferdayanira.freites@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient will not know if his bDMARD treatment was prescribed with or without the help of SinnoTest® software
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study is a prospective, phase III, controlled, multicenter, and randomized in 2 parallel groups, single-blind (patient) with binded outcome assessment 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).

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 31, 2019
• Study Start: December 16, 2019
• Primary Completion: July 1, 2020
• Study Completion: January 1, 2021
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

ES (5)