Biologic National Registry

NCT03793660 | Completed DMC

• 1 other identifier: DAC-004-LITAR
• Study Type: observational
• Target: 439
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Arthritis, Rheumatoid; Spondylitis

Keywords

Biologic; Safety; LITAR; DACIMA; Tunisia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Assessment of Rheumatoid Arthritis Activity

  At baseline and at two years follow-up

• Health Assessment Questionnaire

  At baseline

• Assessment of Spondylitis Fonctional Activity

  At baseline and at two years follow-up

• Assessment of Spondylitis Disease Activity

  At baseline and at two years follow-up

• Assessment of Spondylitis Activity

  At baseline and at two years follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients treated with biologic for rheumatoid arthritis or spondylitis

You may qualify if:

• Age ≥ 18 years
• Patient followed for rheumatoid arthritis according to ACR EULAR criteria or spondylitis including all disorders (axial, peripheral, enthesitis).
• First biological treatment initiated ≤ 2 years
• Informed consent, read and signed

You may not qualify if:

• Other associated systemic diseases, except Sjögren's Syndrome
• Consent not obtained
• Pregnant or lactating woman

Sponsors & Collaborators

• Dacima Consulting: lead
• Ligue Tunisienne Anti Rhumatismale: collaborator

Study Sites (10)

Rheumatology Department - Habib Thameur

Ben Arous, Tunisia

Location

Rheumatology Department - HMPIT

Ben Arous, Tunisia

Location

Rheumatology Department - Tahar Sfar

Mahdia, Tunisia

Location

Rheumatology Department - Institut Mohamed Kassab d'Orthopédie

Manouba, Tunisia

Location

Rheumatology Department - Fattouma Bourguiba

Monastir, Tunisia

Location

Rheumatology Department - Hédi Chaker

Sfax, Tunisia

Location

Rheumatology Department - Farhat Hached

Sousse, Tunisia

Location

Rheumatology Department - Charles Nicolle

Tunis, Tunisia

Location

Rheumatology Department - La Rabta

Tunis, Tunisia

Location

Rheumatology Department - Mongi Slim

Tunis, Tunisia

Location

Related Links

• Social Media Group of the Project

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases, Infectious; Infections; Bone Diseases; Spinal Diseases

Study Officials

• Samir Kochbati, MD

  LITAR : Ligue Tunisienne Anti Rhumatismale

  STUDY CHAIR

• Kawther Ben Abdelghani, MD

  LITAR : Ligue Tunisienne Anti Rhumatismale

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2018
• First Posted: January 4, 2019
• Study Start: May 23, 2018
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: August 22, 2022

Record last verified: 2022-08

Locations

TU (10)