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

January 7, 2020 updated by: Benjamin Fernandez Gutierrez, Hospital San Carlos, Madrid

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
          • Mónica Vázquez-Díaz, MD, PhD
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de octubre
        • Contact:
          • José Luis Pablos Álvarez, MD, PhD
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Clínico San Carlos
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Dalifer Freites Nuñez, MD
      • Madrid, Spain, 28006
        • Active, not recruiting
        • Hospital Universitario La Princesa
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario de La Paz
        • Contact:
          • Alejandro Balsa Criado, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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®.
12 months
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.
6 months
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
Inclusion and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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®
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San Carlos, Madrid

Investigators

  • Principal Investigator: Benjamín Fernández-Gutiérrez, MD, PhD, Hospital San Carlos, Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2019

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

October 25, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

October 31, 2019

Study Record Updates

Last Update Posted (Actual)

January 9, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUR.PREDIRA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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