Biologic National Registry (BINAR)

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

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

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid; Spondylitis

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).

• Study Type: Observational
• Enrollment (Actual): 439

Contacts and Locations

Study Locations

• Tunisia
  • Ben Arous, Tunisia
    • Rheumatology Department - Habib Thameur
  • Ben Arous, Tunisia
    • Rheumatology Department - HMPIT
  • Mahdia, Tunisia
    • Rheumatology Department - Tahar Sfar
  • Manouba, Tunisia
    • Rheumatology Department - Institut Mohamed Kassab d'Orthopédie
  • Monastir, Tunisia
    • Rheumatology Department - Fattouma Bourguiba
  • Sfax, Tunisia
    • Rheumatology Department - Hédi Chaker
  • Sousse, Tunisia
    • Rheumatology Department - Farhat Hached
  • Tunis, Tunisia
    • Rheumatology Department - Charles Nicolle
  • Tunis, Tunisia
    • Rheumatology Department - La Rabta
  • Tunis, Tunisia
    • Rheumatology Department - Mongi Slim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients treated with biologic for rheumatoid arthritis or spondylitis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dacima Consulting
• Collaborators: Ligue Tunisienne Anti Rhumatismale
• Investigators: Study Chair: Samir Kochbati, MD, LITAR : Ligue Tunisienne Anti Rhumatismale; Principal Investigator: Kawther Ben Abdelghani, MD, LITAR : Ligue Tunisienne Anti Rhumatismale

Publications and helpful links

Helpful Links

• Social Media Group of the Project

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: December 29, 2018
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Biologic; Tunisia; LITAR; DACIMA
• Additional Relevant MeSH Terms: Infections; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Arthritis, Rheumatoid; Spondylitis
• Other Study ID Numbers: DAC-004-LITAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No