ITMO public health
Last update : 06/30/2022 | Version : 1 | ID : 74131
| General | |
| Identification | |
| Detailed name | Descriptive epidemiological study of therapeutic decision-making during management of rheumatoid arthritis: physicians’ criteria and patients’ opinions |
| Sign or acronym | DUO |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | ML22021 |
| General Aspects | |
| Medical area |
Rheumatology |
| Study in connection with Covid-19 |
No |
| Pathology (details) | Rheumatoid arthritis |
| Health determinants |
Iatrogenic Medicine |
| Keywords | Tocilizumab |
| Scientific investigator(s) (Contact) | |
| Name of the director | Roche Medical Data Center |
| Address | 4 cours de l'Ile Seguin - 92650 BOULOGNE-BILLANCOURT |
| data_sharing_france@roche.com | |
| Organization | Roche SAS |
| Collaborations | |
| Participation in projects, networks and consortia |
No |
| Funding | |
| Funding status |
Private |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Roche SAS |
| Organisation status |
Private |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Name of the contact | https://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.html |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective |
Primary objectives: To describe the criteria used for therapeutic decision-making for RA patients:
- clinical, biological and radiological data, impact of RA on patients’ life according to physicians; - impact of RA on patients’ life according to patients; - physicians’ characteristics. Secondary objectives: - To describe the characteristics of the included patient population depending on treatment modifications after the inclusion visit. |
| Inclusion criteria |
Inclusion criteria:
- Adult (aged >= 18 years); - Treated for RA; - Willing and able to complete the self-questionnaire in French on the impact of RA during the visit; - Having been informed about the study orally and in writing and not objecting to their data being processed. Exclusion criteria: - Patients participating in another clinical study assessing RA treatment at the time of inclusion. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Pathology | M05-M14 - Inflammatory polyarthropathies |
| Gender |
Male Woman |
| Geography area |
National |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 |
| Date of last collection (YYYY or MM/YYYY) | 2009 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1115 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | Date of inclusion visit - Patient information about the study - General data: age, sex, weight, height - Date of initial diagnosis - Disease characteristics - Ongoing symptomatic treatment or corticosteroids (dose) - Past and current DMARDs: names of compounds (methotrexate, hydroxychloroquine, sulfasalazine, gold salts, leflunomide, D-penicillamine, azathioprine, cyclosporine, infliximab, etanercept, adalimumab, abatacept, rituximab, anakinra, others), ongoing therapeutic regimens, route of administration and date of implementation of methotrexate (if applicable), date of last infusion of rituximab (if applicable) - Safety: any adverse reactions or discomfort experienced by the patient, according to the physician - Patient interview: global RA activity (VAS), degree of asthenia, intensity of pain, duration of morning stiffness, nocturnal wakening related to RA - Clinical examination: localisation of tender joints and swollen joints (out of 28) - Biological examination (last available for 2009): dates and values of ESR (1st hour), CRP and hemoglobin concentration - DAS 28 (if calculated), with ESR or CRP for the calculation - Treatment prescribed at the end of the visit (whether treament modified or not) - Conditions under which the patient self-questionnaire was completed: before the visit/during the visit but before the therapeutic decision was made, other (to precise). |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Data collection method | paper |
| Classifications used | CDISC |
| Quality procedure(s) used | GCP/GVP |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the referring doctor |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Dedicated website | https://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.html |
| Presence of document that lists variables and coding procedures |
Yes |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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