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Assessment of the Clinical and Medico-economic Impact of SinnoTest® in Patients With Rheumatoid Arthritis (SINNO-RA)

Primary Purpose

Arthritis, Rheumatoid, Biological Therapy

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biotherapy Prescription with SinnoTest® software
Patient Current Care
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthritis, Rheumatoid focused on measuring predictive software, quality of life

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Rheumatoid Arthritis defined according to ACR/EULAR 2010 or ACR 1987 criteria.
  • Patients in failure (patient insufficiently responding to anti-TNF treatment DAS28 > 3.2 whether related to primary biotherapy failure, loss of efficacy (loss of response) or adverse event) of a first bDMARD of the anti-TNF family (Adalimumab, Infliximab, Etanercept, Certolizumab or Golimumab).
  • Stability of synthetic fund processing for 3 months.
  • Corticosteroids ≤ 0.1 mg/kg/day without cortisone assault within 3 months.
  • Effective contraception for patients with reproductive capacity (oral contraceptive, intrauterine device, implant, surgical sterilization or abstinence).
  • Patients who have dated and signed the consent form for the trial.
  • Patients affiliated to a social security system.

Exclusion Criteria:

  • Contraindication to at least one of the following bDMARDs: Rituximab and/or Abatacept and/or Adalimumab.
  • Scheduled surgical intervention during the trial.
  • Difficulties in understanding the French language.
  • Cognitive function disorders (dementia such as Alzheimer's, etc.).
  • Patients who cannot be followed up at 12 months.
  • Psycho-social instability incompatible with regular follow-up (homelessness, addictive behavior, a history of psychiatric pathology or any other comorbidity that would make free and informed consent impossible or limit adherence to the protocol).
  • Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant woman, parturient, breastfeeding mother, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure).
  • Patients currently participating in other clinical research or who participated in a clinical trial within one month prior to inclusion.

Sites / Locations

  • Chu Amiens
  • CHU J Minjoz
  • Groupe Hospitalier Pellegrin - CHU de Bordeaux
  • CHU Cavale Blanche
  • Clinique de l'infirmerie protestante
  • Hôpital G. Montpied
  • CHU DIJON Hôpital le Bocage
  • Grenoble University Hospital
  • CHU Montpellier Hôpital Lapeyronie
  • CHU NANTES - Hôtel Dieu
  • APHP Groupe hospitalier Pitié-Salpêtrière
  • APHP Hôpital Cochin
  • CHU Rouen Hôpital bois-guillaume
  • CHU Saint-Etienne
  • CHU Strasbourg Hôpital HAUTEPIERRE
  • Hôpital PURPAN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SinnoTest® software

Patient Current care

Arm Description

SinnoTest® is a therapeutic guidance device for patients suffering from chronic inflammatory rheumatism, in particular, rheumatoid arthritis. Prescription of bDMARD or their biosimilars is possible.

Current care of patients with rheumatoid arthritis, based on the recommendations of the French Society of Rheumatology. Prescription of bDMARD or their biosimilars is possible.

Outcomes

Primary Outcome Measures

Clinical benefit of using SinnoTest® software at 6 months
Clinical benefit of using SinnoTest® software in patients with RA who have failed to respond to a bDMARD of the anti-TNF family compared to usual care practice

Secondary Outcome Measures

Clinical benefit of using SinnoTest® software at 1 year
Patients who respond according to the disease activity criteria from the DAS28 scale
Comparison of the response delay to a bDMARD and the number of bDMARDs prescribed during 12 months in both arms.
The delay and the number of bDMARDs prescribed before a good response
Performance of the software predictive model on the new clinical data from the trial at 6 months and 1 year
Description of the properties of the prediction algorithms on the data of the study
Comparison of the variation in the proteomic profile between M0 (biotherapy start date) and M6
Determination of the blood proteomic profile
Cost-utility analysis that will compare the 2 groups at 1 year from the community's perspective.
EuroQol five Dimensions questionnaire (EQ-5D-5L). The ratio will therefore be expressed as a cost per QALY earned, which represents the additional cost that will be required to earn a healthy year of life
Cost-effectiveness analysis that will compare the group with SinnoTest® compared to the group without SinnoTest®, at 1 year from the community's point of view.
Incremental Cost-Effectiveness Ratio (ICER)
Budget impact analysis from the point of view of Health Insurance at 3 and 5 years.
Measurement of the financial consequences for the Health Insurance of the implementation of SinnoTest® in the context of rheumatoid arthritis at 3- and 5-years' time point.

Full Information

First Posted
September 30, 2019
Last Updated
April 28, 2021
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT04117165
Brief Title
Assessment of the Clinical and Medico-economic Impact of SinnoTest® in Patients With Rheumatoid Arthritis
Acronym
SINNO-RA
Official Title
Assessment of the Clinical and Medico-economic Impact of SinnoTest®, a Software That Predicts the Effectiveness of Biotherapy Treatments, in Patients With Rheumatoid Arthritis (RA)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Rheumatoid arthritis (RA) is one of the main chronic inflammatory rheumatic diseases (RCI), with a prevalence of about 0.4% of the population. First-line treatment with immunomodulators (synthetic and biological Disease Modifying Anti-Rheumatic Drugs (sDMARDs) including methotrexate) is not sufficiently effective in 40% of cases. These patients are then treated with biological Disease Modifying Anti-Rheumatic Drugs (bDMARDs) called biotherapies. As the use of these bio-drugs increases each year, they become a major public health and economic issue. Their growth is only just beginning, as they are among the major providers of pharmaceutical innovation. There are about ten bio-drugs currently on the market for rheumatoid arthritis with an average annual treatment cost of 8 to 12 000 euros per patient. This cost is 20 times higher than that of sDMARDs. However, among patients treated with biotherapy, clinical practice shows that approximately one-third (33%) will not respond to the selected bio-drugs. In the event of non-response, physicians currently have no choice but to rotate empirically between different treatments, as no tools capable of predicting response or non-response to these molecules are currently available. SinnoTest® software, a predictive algorithm for responding to bDMARDs by analyzing proteomic biomarkers, will clarify this choice of prescription for patients with failed RA of a first bDMARD in the anti-TNF family.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid, Biological Therapy
Keywords
predictive software, quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective clinical trial, phase III, randomized in 2 parallel groups, multicentric, controlled (prescription with SinnoTest® software versus prescription without SinnoTest® software), single-blind
Masking
Participant
Masking Description
The patient will not know if his bDMARD treatment was prescribed with or without the help of SinnoTest® software
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SinnoTest® software
Arm Type
Experimental
Arm Description
SinnoTest® is a therapeutic guidance device for patients suffering from chronic inflammatory rheumatism, in particular, rheumatoid arthritis. Prescription of bDMARD or their biosimilars is possible.
Arm Title
Patient Current care
Arm Type
Active Comparator
Arm Description
Current care of patients with rheumatoid arthritis, based on the recommendations of the French Society of Rheumatology. Prescription of bDMARD or their biosimilars is possible.
Intervention Type
Diagnostic Test
Intervention Name(s)
Biotherapy Prescription with SinnoTest® software
Intervention Description
The rheumatologist will use the SinnoTest® software to give the best biotherapy to the patient according to the results of the software.
Intervention Type
Drug
Intervention Name(s)
Patient Current Care
Other Intervention Name(s)
Biotherapy treatment without SinnoTest®
Intervention Description
The rheumatologist will use the french guidelines of rheumatoid arthritis to choose the more adapted biotherapy treatment to the patient.
Primary Outcome Measure Information:
Title
Clinical benefit of using SinnoTest® software at 6 months
Description
Clinical benefit of using SinnoTest® software in patients with RA who have failed to respond to a bDMARD of the anti-TNF family compared to usual care practice
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical benefit of using SinnoTest® software at 1 year
Description
Patients who respond according to the disease activity criteria from the DAS28 scale
Time Frame
1 year
Title
Comparison of the response delay to a bDMARD and the number of bDMARDs prescribed during 12 months in both arms.
Description
The delay and the number of bDMARDs prescribed before a good response
Time Frame
1 year
Title
Performance of the software predictive model on the new clinical data from the trial at 6 months and 1 year
Description
Description of the properties of the prediction algorithms on the data of the study
Time Frame
6 months and 1 year
Title
Comparison of the variation in the proteomic profile between M0 (biotherapy start date) and M6
Description
Determination of the blood proteomic profile
Time Frame
Inclusion and 6 months
Title
Cost-utility analysis that will compare the 2 groups at 1 year from the community's perspective.
Description
EuroQol five Dimensions questionnaire (EQ-5D-5L). The ratio will therefore be expressed as a cost per QALY earned, which represents the additional cost that will be required to earn a healthy year of life
Time Frame
1 year
Title
Cost-effectiveness analysis that will compare the group with SinnoTest® compared to the group without SinnoTest®, at 1 year from the community's point of view.
Description
Incremental Cost-Effectiveness Ratio (ICER)
Time Frame
1 year
Title
Budget impact analysis from the point of view of Health Insurance at 3 and 5 years.
Description
Measurement of the financial consequences for the Health Insurance of the implementation of SinnoTest® in the context of rheumatoid arthritis at 3- and 5-years' time point.
Time Frame
3 and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Rheumatoid Arthritis defined according to ACR/EULAR 2010 or ACR 1987 criteria. Patients in failure (patient insufficiently responding to anti-TNF treatment DAS28 > 3.2 whether related to primary biotherapy failure, loss of efficacy (loss of response) or adverse event) of a first bDMARD of the anti-TNF family (Adalimumab, Infliximab, Etanercept, Certolizumab or Golimumab). Stability of synthetic fund processing for 3 months. Corticosteroids ≤ 0.1 mg/kg/day without cortisone assault within 3 months. Effective contraception for patients with reproductive capacity (oral contraceptive, intrauterine device, implant, surgical sterilization or abstinence). Patients who have dated and signed the consent form for the trial. Patients affiliated to a social security system. Exclusion Criteria: Contraindication to at least one of the following bDMARDs: Rituximab and/or Abatacept and/or Adalimumab. Scheduled surgical intervention during the trial. Difficulties in understanding the French language. Cognitive function disorders (dementia such as Alzheimer's, etc.). Patients who cannot be followed up at 12 months. Psycho-social instability incompatible with regular follow-up (homelessness, addictive behavior, a history of psychiatric pathology or any other comorbidity that would make free and informed consent impossible or limit adherence to the protocol). Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant woman, parturient, breastfeeding mother, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure). Patients currently participating in other clinical research or who participated in a clinical trial within one month prior to inclusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe GAUDIN, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Amiens
City
Amiens
Country
France
Facility Name
CHU J Minjoz
City
Besançon
Country
France
Facility Name
Groupe Hospitalier Pellegrin - CHU de Bordeaux
City
Bordeaux
Country
France
Facility Name
CHU Cavale Blanche
City
Brest
Country
France
Facility Name
Clinique de l'infirmerie protestante
City
Caluire-et-Cuire
Country
France
Facility Name
Hôpital G. Montpied
City
Clermont-Ferrand
Country
France
Facility Name
CHU DIJON Hôpital le Bocage
City
Dijon
Country
France
Facility Name
Grenoble University Hospital
City
Grenoble
Country
France
Facility Name
CHU Montpellier Hôpital Lapeyronie
City
Montpellier
Country
France
Facility Name
CHU NANTES - Hôtel Dieu
City
Nantes
Country
France
Facility Name
APHP Groupe hospitalier Pitié-Salpêtrière
City
Paris
Country
France
Facility Name
APHP Hôpital Cochin
City
Paris
Country
France
Facility Name
CHU Rouen Hôpital bois-guillaume
City
Rouen
Country
France
Facility Name
CHU Saint-Etienne
City
Saint-Étienne
Country
France
Facility Name
CHU Strasbourg Hôpital HAUTEPIERRE
City
Strasbourg
Country
France
Facility Name
Hôpital PURPAN
City
Toulouse
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29885551
Citation
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.
Results Reference
background
PubMed Identifier
30243783
Citation
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.
Results Reference
background
PubMed Identifier
30919904
Citation
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.
Results Reference
background
PubMed Identifier
20100792
Citation
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.
Results Reference
background
PubMed Identifier
18664547
Citation
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.
Results Reference
background

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Assessment of the Clinical and Medico-economic Impact of SinnoTest® in Patients With Rheumatoid Arthritis

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