Biologic National Registry
- Conditions
- Arthritis, RheumatoidSpondylitis
- Registration Number
- NCT03793660
- Lead Sponsor
- Dacima Consulting
- Brief 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 439
- 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
- Evolutionary neoplasia at the time of inclusion
- Other associated systemic diseases, except Sjögren's Syndrome
- Consent not obtained
- Pregnant or lactating woman
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety assessment of biotherapy - Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Occurrence of infection or tuberculosis or death or neoplasia or any other treatment-related side effect of biotherapy Up to two years of follow-up Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\] : occurrence of infection or tuberculosis or death or neoplasia or any other treatment-related side effect of biotherapy
- Secondary Outcome Measures
Name Time Method Assessment of Rheumatoid Arthritis Activity At baseline and at two years follow-up Number of patients with disease Activity Score (DAS) \< 2.6
Assessment of Spondylitis Disease Activity At baseline and at two years follow-up Bath Ankylosing Spondylitis Disease Activity Index measurement (BASDAI) : (range score 0-10)
Assessment of Spondylitis Fonctional Activity At baseline and at two years follow-up Bath Ankylosing Spondylitis Fonctional Index measurement (BASFI) : (range score 0-10)
Assessment of Spondylitis Activity At baseline and at two years follow-up Number of patients with Ankylosing Spondylitis Disease Activity Score (ASDAS) \< 2.1
Health Assessment Questionnaire At baseline HAQ assessment for Rheumatoid Arthritis patients (range score 0-3)
Trial Locations
- Locations (10)
Rheumatology Department - Hédi Chaker
🇹🇳Sfax, Tunisia
Rheumatology Department - Mongi Slim
🇹🇳Tunis, Tunisia
Rheumatology Department - Farhat Hached
🇹🇳Sousse, Tunisia
Rheumatology Department - Tahar Sfar
🇹🇳Mahdia, Tunisia
Rheumatology Department - Institut Mohamed Kassab d'Orthopédie
🇹🇳Manouba, Tunisia
Rheumatology Department - Habib Thameur
🇹🇳Ben Arous, Tunisia
Rheumatology Department - HMPIT
🇹🇳Ben Arous, Tunisia
Rheumatology Department - Fattouma Bourguiba
🇹🇳Monastir, Tunisia
Rheumatology Department - Charles Nicolle
🇹🇳Tunis, Tunisia
Rheumatology Department - La Rabta
🇹🇳Tunis, Tunisia