Arthritis, RheumatoidSINNO-RANCT04117165

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

A study testing Biotherapy Prescription with SinnoTest® software and Patient Current Care in people with Arthritis, Rheumatoid and Biological Therapy, run by University Hospital, Grenoble at 16 sites in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Arthritis, Rheumatoid, Biological Therapy
What is being tested?: Biotherapy Prescription with SinnoTest® software and Patient Current Care
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 16 sitesFrance
Study dates: 1 Mar 2021to 1 Sep 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

France16 sites

Chu Amiens
Amiens
CHU J Minjoz
Besançon
Groupe Hospitalier Pellegrin - CHU de Bordeaux
Bordeaux
CHU Cavale Blanche
Brest
Clinique de l'infirmerie protestante
Caluire-et-Cuire
Hôpital G. Montpied
Clermont-Ferrand
CHU DIJON Hôpital le Bocage
Dijon
Grenoble University Hospital
Grenoble
CHU Montpellier Hôpital Lapeyronie
Montpellier
CHU NANTES - Hôtel Dieu
Nantes
APHP Groupe hospitalier Pitié-Salpêtrière
Paris
APHP Hôpital Cochin
Paris
CHU Rouen Hôpital bois-guillaume
Rouen
CHU Saint-Etienne
Saint-Etienne
CHU Strasbourg Hôpital HAUTEPIERRE
Strasbourg
Hôpital PURPAN
Toulouse

Other trials in France

About this study

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)

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
Being tested: Biotherapy Prescription with SinnoTest® software, Patient Current Care
Keywords: predictive software, quality of life
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Biotherapy Prescription with SinnoTest® softwareDiagnostic test
The rheumatologist will use the SinnoTest® software to give the best biotherapy to the patient according to the results of the software.
Patient Current CareDrug
Also called Biotherapy treatment without SinnoTest®
The rheumatologist will use the french guidelines of rheumatoid arthritis to choose the more adapted biotherapy treatment to the patient.

Study groups in NCT04117165
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Patient Current Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 6 months

Secondary outcomes (7)

Clinical benefit of using SinnoTest® software at 1 year
Patients who respond according to the disease activity criteria from the DAS28 scale
Measured: 1 year
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
Measured: 1 year
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
Measured: 6 months and 1 year
Comparison of the variation in the proteomic profile between M0 (biotherapy start date) and M6
Determination of the blood proteomic profile
Measured: Inclusion and 6 months
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
Measured: 1 year
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)
Measured: 1 year
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.
Measured: 3 and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20211 Sep 2023

First posted7 Oct 2019
Study start1 Mar 2021
Primary completion1 Sep 2022 (estimated)
Study completion1 Sep 2023 (estimated)

Why it stopped: No funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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: Single blind
Who is masked: Participant
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04117165
Sponsor's protocol ID: 2019-A01709-48
Acronym: SINNO-RA
Status last verified: Apr 2021
First submitted: 30 Sep 2019
Last updated: 3 May 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 29885551
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.
PubMed 30243783
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.
PubMed 30919904
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.
PubMed 20100792
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.
PubMed 18664547

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Arthritis, Rheumatoid trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT04117165
Acronym / sponsor ID: SINNO-RA / 2019-A01709-48
Conditions: Arthritis, Rheumatoid, Biological Therapy
Keywords: predictive software, quality of life
Study type: Interventional
Recruitment status: WithdrawnReason stopped: No funding
Enrolment: 0 participants (actual)
Lead sponsor: University Hospital, GrenobleUniversity, hospital or other
Study start: 1 Mar 2021 (actual)
Primary completion: 1 Sep 2022 (estimated)
Study completion: 1 Sep 2023 (estimated)
First posted: 7 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Rheumatoid arthritis (RA) is one of the main chronic inflammatory rheumatic diseases (RCI), with a prevalence of about 0.4% of the population.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
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

Arm	Type	Receives
SinnoTest® software	Experimental	Diagnostic Test: Biotherapy Prescription with SinnoTest® softwareSinnoTest® is a therapeutic guidance device for patients suffering from chronic inflammatory rheumatism, in particular, rheumatoid arthritis. Prescription of bDMARD or their biosimilars is possible.
Patient Current care	Active comparator	Drug: Patient Current CareCurrent care of patients with rheumatoid arthritis, based on the recommendations of the French Society of Rheumatology. Prescription of bDMARD or their biosimilars is possible.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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).

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Biotherapy Prescription with SinnoTest® softwareThe rheumatologist will use the SinnoTest® software to give the best biotherapy to the patient according to the results of the software.	Diagnostic test	SinnoTest® software
Patient Current CareAlso: Biotherapy treatment without SinnoTest®The rheumatologist will use the french guidelines of rheumatoid arthritis to choose the more adapted biotherapy treatment to the patient.	Drug	Patient Current care

Primary outcome

Clinical benefit of using SinnoTest® software at 6 months
Time frame: 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

7 secondary outcomes

Clinical benefit of using SinnoTest® software at 1 year
Time frame: 1 year
Comparison of the response delay to a bDMARD and the number of bDMARDs prescribed during 12 months in both arms.
Time frame: 1 year
Performance of the software predictive model on the new clinical data from the trial at 6 months and 1 year
Time frame: 6 months and 1 year
Comparison of the variation in the proteomic profile between M0 (biotherapy start date) and M6
Time frame: Inclusion and 6 months
Cost-utility analysis that will compare the 2 groups at 1 year from the community's perspective.
Time frame: 1 year
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.
Time frame: 1 year
Budget impact analysis from the point of view of Health Insurance at 3 and 5 years.
Time frame: 3 and 5 years

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
Background: PubMed 29885551Nguyen 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.
Background: PubMed 30243783Nguyen 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.
Background: PubMed 30919904Baillet 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.
Background: PubMed 20100792Baillet 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.
Background: PubMed 18664547Trocme 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Philippe GAUDIN, PhD principal investigator

University Hospital, Grenoble

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical benefit of using SinnoTest® software at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04117165, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.