Biologic National Registry (BINAR)

DACIMA

Status: Completed

Conditions: Spondylitis; Arthritis, Rheumatoid

Study type: Observational

Funder types: Other

Identifiers

NCT03793660

DAC-004-LITAR

Details and patient eligibility

About

BINAR is an open and multicentric Tunisian national registry performed by nearly 100 rheumatologists

Full description

BINAR is a Tunisian, descriptive, non-interventional, multicenter and prospective clinical study performed in rheumatology consultations, of both public and liberal sectors. Eligible patients are recruited by successive inclusions until the end of the recruitment period, set at one year. A Scientific Committee validates the scientific writing, a Steering Committee supervises the clinical operations of the project and a Data Review Committee supervises the management of the data and carries out all the missions of audit and control of validity of the collected data, as well as the planning of statistical analysis.

Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).

Enrollment: 439 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Patient followed for rheumatoid arthritis according to ACR EULAR criteria or spondylitis including all disorders (axial, peripheral, enthesitis).
• Patient on biological treatment at the time of inclusion
• First biological treatment initiated ≤ 2 years
• Informed consent, read and signed

Exclusion criteria

• Evolutionary neoplasia at the time of inclusion
• Other associated systemic diseases, except Sjögren's Syndrome
• Consent not obtained
• Pregnant or lactating woman