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Prediction Medical Device for Rheumatoid Arthritis (PREDIRA) (PREDIRA)

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ClinicalTrials.gov Identifier: NCT04147026
Recruitment Status : Recruiting
First Posted : October 31, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Benjamin Fernandez Gutierrez, Hospital San Carlos, Madrid

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.


Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Device: SinnoTest® Other: Biotherapy prescription without SinnoTest® software Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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).
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The patient will not know if his bDMARD treatment was prescribed with or without the help of SinnoTest® software
Primary Purpose: Treatment
Official Title: PRediction mEdical DevIce for Rheumatoid Arthritis: Scale-up of Unique Predictive Online Platform Highly Improving the Quality of Life of Rheumatoid Arthritis' Patient by Personalised and Efficient Biotherapies Prescription
Actual Study Start Date : December 16, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: 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.


Active Comparator: Current practice
Prescription of biotherapy without the SinnoTest® software which corresponds to current practice (all biotherapies).
Other: 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




Primary Outcome Measures :
  1. Incremental Cost Utility ratio at 6 months [ Time Frame: 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



Secondary Outcome Measures :
  1. Budget impact analysis at 6 and 12 months [ Time Frame: 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®.


  2. Software's predictive model performance [ Time Frame: 6 months ]
    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.

  3. Description of the variation of the proteomic profile between M0 (biotherapy start date) and M6 (6 months visit) [ Time Frame: Inclusion and 6 months ]
    Based on shotgun and semiquantitative proteomics, the diferences between the proteomic profile at baseline and at M6 will be analyzed


Other Outcome Measures:
  1. Incremental Cost Effectiveness ratio at 6 months [ Time Frame: 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 as the percentage of patients achieving a good clinical response in each study arm (% in the Sinnotest® Arm - % in the Control Arm).

    Good clinical response will be measured using the EULAR criteria of Good clinical response Cost will be considered from a Societal perspective, including both direct and indirect costs The ratio will be expressed in cost (2019 Euros) per increase in 1% of subjects achieving a Good Clinical Response, which represents the additional cost that will have to be spent to earn a healthy year of life

    rates of treatment-response patients associated respectively with the usual strategy without SinnoTest® and with the strategy with SinnoTest®




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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,
  • Stability of treatments (no change) between the selection visit and the inclusion visit (M0).

Exclusion Criteria:

  • 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),
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04147026


Contacts
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Contact: Luis Rodriguez-Rodriguez, MD, PhD +34913303615 ext 7560 lrrodriguez@salud.madrid.org
Contact: Dalifer Freites Nuñez, MD +34913303615 daliferdayanira.freites@salud.madrid.org

Locations
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Spain
Hospital Universitario La Princesa Active, not recruiting
Madrid, Spain, 28006
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Contact: Mónica Vázquez-Díaz, MD, PhD         
Hospital Universitario Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Benjamin Fernandez-Gutierrez, MD, PhD    +34913303615 ext 7803    bfernandez.hcsc@salud.madrid.org   
Contact: Luis Rodriguez-Rodriguez, MD, PhD    +34913303615 ext 7560    lrrodriguez@salud.madrid.org   
Sub-Investigator: Dalifer Freites Nuñez, MD         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: José Luis Pablos Álvarez, MD, PhD         
Hospital Universitario de La Paz Recruiting
Madrid, Spain, 28046
Contact: Alejandro Balsa Criado, MD, PhD         
Sponsors and Collaborators
Hospital San Carlos, Madrid
Investigators
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Principal Investigator: Benjamín Fernández-Gutiérrez, MD, PhD Hospital Clínico San Carlos
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Benjamin Fernandez Gutierrez, Principal Investigator, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT04147026    
Other Study ID Numbers: EUR.PREDIRA
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benjamin Fernandez Gutierrez, Hospital San Carlos, Madrid:
Biological therapy
Predictive software
Quality of life
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases