GO-PRACTICE - Study of the conditions of use of golimumab and its impact, in current practice, in patients with chronic inflammatory rheumatism.
Head :
LEVY-BACHELOT Laurie, MSD France
Gouyette Najat, MSD France
Gouyette Najat, MSD France
Last update : 10/19/2017 | Version : 1 | ID : 73342
| General | |
| Identification | |
| Detailed name | Study of the conditions of use of golimumab and its impact, in current practice, in patients with chronic inflammatory rheumatism. |
| Sign or acronym | GO-PRACTICE |
| General Aspects | |
| Medical area |
Rheumatology |
| Pathology (details) | Rheumatoid arthritis, ankylosing spondylitis and rheumatic psoriasis |
| Scientific investigator(s) (Contact) | |
| Name of the director | LEVY-BACHELOT |
| Surname | Laurie |
| Address | 34 avenue Léonard de Vinci, Courbevoie |
| Phone | 01 80 46 41 98 |
| laurie.levy-bachelot@merck.com | |
| Unit | MSD France |
| Name of the director | Gouyette |
| Surname | Najat |
| Unit | MSD France |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | MSD France |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | MSD France |
| Organisation status |
Private |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database objective | |
| Main objective |
To evaluate the maintenance of golimumab therapy 24 months after initial prescription in adult patients with chronic inflammatory rheumatism in clinical practice in France
The primary endpoint is the total percentage of patients who maintained treatment with golimumab two years after the initial prescription. |
| Inclusion criteria |
Inclusion:
1. Patients aged 18 years or older. 2. Patients who gave oral consent to participate after receiving oral and written information about the study. 3. Patients with a diagnosis of chronic inflammatory rheumatism. 4. Patients with an initial hospital prescription of golimumab but not yet having initiated treatment with golimumab. 5. Patients able to understand and complete the self-evaluation questionnaires Non-inclusion: 1. Patients previously treated with golimumab and discontinuing treatment prior to inclusion. 2. Patients who participated in previous golimumab trials 3. Patients who had already begun treatment with golimumab prior to inclusion and were receiving treatment at the time of inclusion. 4. Patients with pathologies or conditions that, according to the investigator, would limit the patient's ability to participate fully in the study or to meet all the requirements of the study; |
| 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 |
| Detail of the geography area | No details available |
| Data collection | |
| Dates | |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 750 included |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire |
| Presence of a biobank |
No |
| Procedures | |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the participant (mail, e-mail, telephone etc.) Monitoring by contact with the referring doctor |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | No data access charter |
| Access to aggregated data |
Access not yet planned |
| Access to individual data |
No access |
