Clinical trial NCT03793660: Biologic National Registry
Official title: Safety and Efficacy of Biotherapy in Rheumatoid Aarthritis and Spondyloarthritis. A Clinical Multicentric Study: Biologic National Registry (BINAR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Spondylitis
Keywords: Biologic
Safety
LITAR
DACIMA
Tunisia
Lead sponsor: Dacima Consulting
Sponsor class: OTHER
Collaborators: name: Ligue Tunisienne Anti Rhumatismale
First posted: 2019-01-04
Enrollment: 439
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated with biologic for rheumatoid arthritis or spondylitis

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to two years of follow-up
Secondary outcomes:
measure: Assessment of Rheumatoid Arthritis Activity
timeFrame: At baseline and at two years follow-up
measure: Health Assessment Questionnaire
timeFrame: At baseline
measure: Assessment of Spondylitis Fonctional Activity
timeFrame: At baseline and at two years follow-up
measure: Assessment of Spondylitis Disease Activity
timeFrame: At baseline and at two years follow-up
measure: Assessment of Spondylitis Activity
timeFrame: At baseline and at two years follow-up
Other outcomes:
Locations:
city: Ben Arous
country: Tunisia
facility: Rheumatology Department - Habib Thameur
city: Ben Arous
country: Tunisia
facility: Rheumatology Department - HMPIT
city: Mahdia
country: Tunisia
facility: Rheumatology Department - Tahar Sfar
city: Manouba
country: Tunisia
facility: Rheumatology Department - Institut Mohamed Kassab d'Orthopédie
city: Monastir
country: Tunisia
facility: Rheumatology Department - Fattouma Bourguiba
city: Sfax
country: Tunisia
facility: Rheumatology Department - Hédi Chaker
city: Sousse
country: Tunisia
facility: Rheumatology Department - Farhat Hached
city: Tunis
country: Tunisia
facility: Rheumatology Department - Charles Nicolle
city: Tunis
country: Tunisia
facility: Rheumatology Department - La Rabta
city: Tunis
country: Tunisia
facility: Rheumatology Department - Mongi Slim
Study officials:
affiliation: LITAR : Ligue Tunisienne Anti Rhumatismale
name: Samir Kochbati, MD
role: STUDY_CHAIR
affiliation: LITAR : Ligue Tunisienne Anti Rhumatismale
name: Kawther Ben Abdelghani, MD
role: PRINCIPAL_INVESTIGATOR
References: