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| Name | Class |
|---|---|
| Ligue Tunisienne Anti Rhumatismale | UNKNOWN |
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BINAR is an open and multicentric Tunisian national registry performed by nearly 100 rheumatologists
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).
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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All patients treated with biologic for rheumatoid arthritis or spondylitis
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| Name | Affiliation | Role |
|---|---|---|
| Samir Kochbati, MD | LITAR : Ligue Tunisienne Anti Rhumatismale | Study Chair |
| Kawther Ben Abdelghani, MD | LITAR : Ligue Tunisienne Anti Rhumatismale | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Department - Habib Thameur | Ben Arous | Tunisia | ||||
| Rheumatology Department - HMPIT |
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| Label | URL |
|---|---|
| Social Media Group of the Project | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D013166 | Spondylitis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 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 |
| Ben Arous |
| Tunisia |
| Rheumatology Department - Tahar Sfar | Mahdia | Tunisia |
| Rheumatology Department - Institut Mohamed Kassab d'Orthopédie | Manouba | Tunisia |
| Rheumatology Department - Fattouma Bourguiba | Monastir | Tunisia |
| Rheumatology Department - Hédi Chaker | Sfax | Tunisia |
| Rheumatology Department - Farhat Hached | Sousse | Tunisia |
| Rheumatology Department - Charles Nicolle | Tunis | Tunisia |
| Rheumatology Department - La Rabta | Tunis | Tunisia |
| Rheumatology Department - Mongi Slim | Tunis | Tunisia |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001850 | Bone Diseases, Infectious |
| D007239 | Infections |
| D001847 | Bone Diseases |
| D013122 | Spinal Diseases |