Biologic National Registry

Dacima Consulting439 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

439

Conditions

Arthritis, Rheumatoid Spondylitis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Rheumatology Department - Habib Thameur

Ben Arous, Tunisia

Rheumatology Department - HMPIT

Ben Arous, Tunisia

Rheumatology Department - Tahar Sfar

Mahdia, Tunisia

Rheumatology Department - Institut Mohamed Kassab d'Orthopédie

Outcomes

Primary Outcomes

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

Time frame: Up to two years of follow-up

Secondary Outcomes

Assessment of Rheumatoid Arthritis Activity

Number of patients with disease Activity Score (DAS) \< 2.6

Time frame: At baseline and at two years follow-up

Health Assessment Questionnaire

HAQ assessment for Rheumatoid Arthritis patients (range score 0-3)

Time frame: At baseline

Assessment of Spondylitis Fonctional Activity

Bath Ankylosing Spondylitis Fonctional Index measurement (BASFI) : (range score 0-10)

Time frame: 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)

Time frame: At baseline and at two years follow-up

Assessment of Spondylitis Activity

Number of patients with Ankylosing Spondylitis Disease Activity Score (ASDAS) \< 2.1

Time frame: At baseline and at two years follow-up

Data from ClinicalTrials.gov

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