Biologic National Registry

Arthritis, Rheumatoid Clinical Trial

— BINAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03793660
• Other study ID #: DAC-004-LITAR
• Status: Completed
• Start date: May 23, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Dacima Consulting
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

BINAR is an open and multicentric Tunisian national registry performed by nearly 100 rheumatologists

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 information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Spondylitis

Locations

Country	Name	City	State
Tunisia	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	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

Sponsors (2)

Lead Sponsor	Collaborator
Dacima Consulting	Ligue Tunisienne Anti Rhumatismale

Country where clinical trial is conducted

Tunisia, 

Outcome

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

External Links

•   Social Media Group of the Project