NCT03793660

Biologic National Registry

Safety and Efficacy of Biotherapy in Rheumatoid Aarthritis and Spondyloarthritis. A Clinical Multicentric Study: Biologic National Registry (BINAR)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 439 (actual)
• Sponsor: Dacima Consulting · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Arthritis, Rheumatoid
• Spondylitis

Timeline

• Start date: 2018-05-23
• Primary completion: 2021-12-31
• Completion: 2022-06-30
• First posted: 2019-01-04
• Last updated: 2022-08-22

Locations

10 sites across 1 country: Tunisia