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

NCT04117165 | Withdrawn

• 1 other identifier: 2019-A01709-48
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 16

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.

Conditions

Arthritis, Rheumatoid; Biological Therapy

Keywords

predictive software; quality of life

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (7)

• Clinical benefit of using SinnoTest® software at 1 year

  1 year

• Comparison of the response delay to a bDMARD and the number of bDMARDs prescribed during 12 months in both arms.

  1 year

• Performance of the software predictive model on the new clinical data from the trial at 6 months and 1 year

  6 months and 1 year

• Comparison of the variation in the proteomic profile between M0 (biotherapy start date) and M6

  Inclusion and 6 months

• Cost-utility analysis that will compare the 2 groups at 1 year from the community's perspective.

  1 year

Study Arms (2)

SinnoTest® software

EXPERIMENTAL

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.

Diagnostic Test: Biotherapy Prescription with SinnoTest® software

Patient Current care

ACTIVE COMPARATOR

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.

Drug: Patient Current Care

Interventions

Biotherapy Prescription with SinnoTest® software DIAGNOSTIC_TEST

The rheumatologist will use the SinnoTest® software to give the best biotherapy to the patient according to the results of the software.

SinnoTest® software

Patient Current Care DRUG

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

Also known as: Biotherapy treatment without SinnoTest®

Patient Current care

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 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (16)

Chu Amiens

Amiens, France

Location

CHU J Minjoz

Besançon, France

Location

Groupe Hospitalier Pellegrin - CHU de Bordeaux

Bordeaux, France

Location

CHU Cavale Blanche

Brest, France

Location

Clinique de l'infirmerie protestante

Caluire-et-Cuire, France

Location

Hôpital G. Montpied

Clermont-Ferrand, France

Location

CHU DIJON Hôpital le Bocage

Dijon, France

Location

Grenoble University Hospital

Grenoble, France

Location

CHU Montpellier Hôpital Lapeyronie

Montpellier, France

Location

CHU NANTES - Hôtel Dieu

Nantes, France

Location

APHP Groupe hospitalier Pitié-Salpêtrière

Paris, France

Location

APHP Hôpital Cochin

Paris, France

Location

CHU Rouen Hôpital bois-guillaume

Rouen, France

Location

CHU Saint-Etienne

Saint-Etienne, France

Location

CHU Strasbourg Hôpital HAUTEPIERRE

Strasbourg, France

Location

Hôpital PURPAN

Toulouse, France

Location

Related Publications (5)

• 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

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

• Philippe GAUDIN, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will not know if his bDMARD treatment was prescribed with or without the help of SinnoTest® software
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective clinical trial, phase III, randomized in 2 parallel groups, multicentric, controlled (prescription with SinnoTest® software versus prescription without SinnoTest® software), single-blind

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 7, 2019
• Study Start: March 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (16)