Biologic National Registry

Study Overview
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Brief Summary
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BINAR is an open and multicentric Tunisian national registry performed by nearly 100 rheumatologists

Detailed Description
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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).

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

Conditions
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Arthritis, Rheumatoid, Spondylitis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Rheumatoid Arthritis Activity | Number of patients with disease Activity Score (DAS) < 2.6 | At baseline and at two years follow-up | 
| Health Assessment Questionnaire | HAQ assessment for Rheumatoid Arthritis patients (range score 0-3) | At baseline | 
| Assessment of Spondylitis Fonctional Activity | Bath Ankylosing Spondylitis Fonctional Index measurement (BASFI) : (range score 0-10) | At baseline and at two years follow-up | 
| Assessment of Spondylitis Disease Activity | Bath Ankylosing Spondylitis Disease Activity Index measurement (BASDAI) : (range score 0-10) | At baseline and at two years follow-up | 
| Assessment of Spondylitis Activity | Number of patients with Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1 | At baseline and at two years follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biologic, Safety, LITAR, DACIMA, Tunisia