|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
10 May 2021 |
|
Main ID: |
NCT04117165 |
|
Date of registration:
|
30/09/2019 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Assessment of the Clinical and Medico-economic Impact of SinnoTest® in Patients With Rheumatoid Arthritis
SINNO-RA |
|
Scientific 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) |
|
Date of first enrolment:
|
March 1, 2021 |
|
Target sample size:
|
0 |
|
Recruitment status: |
Withdrawn |
|
URL:
|
https://clinicaltrials.gov/show/NCT04117165 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Participant).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Philippe GAUDIN, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Hospital, Grenoble |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Arthritis, Rheumatoid
|
|
Biological Therapy
|
|
Intervention(s)
|
|
Drug: Patient Current Care
|
|
Diagnostic Test: Biotherapy Prescription with SinnoTest® software
|
|
Primary Outcome(s)
|
|
Clinical benefit of using SinnoTest® software at 6 months
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
Clinical benefit of using SinnoTest® software at 1 year
[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]
|
|
Budget impact analysis from the point of view of Health Insurance at 3 and 5 years.
[Time Frame: 3 and 5 years]
|
|
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]
|
|
Comparison of the response delay to a bDMARD and the number of bDMARDs prescribed during 12 months in both arms.
[Time Frame: 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]
|
|
Secondary ID(s)
|
|
2019-A01709-48
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|