Arthritis, Rheumatoid, Spondylitis
Conditions
Keywords
Biologic, Safety, LITAR, DACIMA, Tunisia
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).
Interventions
None listed
Sponsors
Ligue Tunisienne Anti Rhumatismale
Dacima Consulting
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Rheumatoid Arthritis Activity | At baseline and at two years follow-up | Number of patients with disease Activity Score (DAS) \< 2.6 |
| Health Assessment Questionnaire | At baseline | HAQ assessment for Rheumatoid Arthritis patients (range score 0-3) |
| 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 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 Activity | At baseline and at two years follow-up | Number of patients with Ankylosing Spondylitis Disease Activity Score (ASDAS) \< 2.1 |
Countries
Tunisia
Outcome results
None listed