Arthritis, RheumatoidBINARNCT03793660
Biologic National Registry
An observational study of Arthritis, Rheumatoid and Spondylitis, run by Dacima Consulting at 10 sites in Tunisia.
Trial summary
BINAR is an open and multicentric Tunisian national registry performed by nearly 100 rheumatologists Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid, Spondylitis
- How many people
- 439 participants
- Where
- 10 sitesTunisia
- Study dates
- 23 May 2018to 30 Jun 2022
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated with biologic for rheumatoid arthritis or spondylitis
Who may be able to join
- 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
Who cannot join
- Evolutionary neoplasia at the time of inclusion
- Other associated systemic diseases, except Sjögren's Syndrome
- Consent not obtained
- Pregnant or lactating woman
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Tunisia10 sites
Rheumatology Department - Habib Thameur
Ben Arous
Rheumatology Department - HMPIT
Ben Arous
Rheumatology Department - Tahar Sfar
Mahdia
Rheumatology Department - Institut Mohamed Kassab d'Orthopédie
Manouba
Rheumatology Department - Fattouma Bourguiba
Monastir
Rheumatology Department - Hédi Chaker
Sfax
Rheumatology Department - Farhat Hached
Sousse
Rheumatology Department - Charles Nicolle
Tunis
Rheumatology Department - La Rabta
Tunis
Rheumatology Department - Mongi Slim
Tunis
About this study
Official title: 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
Read the 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).
- Conditions
- Arthritis, Rheumatoid, Spondylitis
- Keywords
- Biologic, Safety, LITAR, DACIMA, Tunisia
- Medical subject headings
- Arthritis, Rheumatoid, Spondylitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to two years of follow-up
Secondary outcomes (5)
Assessment of Rheumatoid Arthritis Activity
Number of patients with disease Activity Score (DAS) < 2.6
Measured: At baseline and at two years follow-up
Health Assessment Questionnaire
HAQ assessment for Rheumatoid Arthritis patients (range score 0-3)
Measured: At baseline
Assessment of Spondylitis Fonctional Activity
Bath Ankylosing Spondylitis Fonctional Index measurement (BASFI) : (range score 0-10)
Measured: 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)
Measured: At baseline and at two years follow-up
Assessment of Spondylitis Activity
Number of patients with Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1
Measured: At baseline and at two years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start23 May 2018
- Primary completion31 Dec 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 439 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Dacima Consulting
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue Tunisienne Anti Rhumatismale
- Responsible party
- Sponsor
- Investigators
- Samir Kochbati, MD, Study chair, LITAR : Ligue Tunisienne Anti RhumatismaleKawther Ben Abdelghani, MD, Principal investigator, LITAR : Ligue Tunisienne Anti Rhumatismale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793660
- Sponsor's protocol ID
- DAC-004-LITAR
- Acronym
- BINAR
- Status last verified
- Aug 2022
- First submitted
- 29 Dec 2018
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Biotherapy in Rheumatoid Aarthritis and Spondyloarthritis. A Clinical Multicentric Study: Biologic National Registry (BINAR)
- ClinicalTrials.gov ID
- NCT03793660
- Acronym / sponsor ID
- BINAR / DAC-004-LITAR
- Conditions
- Arthritis, Rheumatoid, Spondylitis
- Keywords
- Biologic, Safety, LITAR, DACIMA, Tunisia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- Dacima ConsultingUniversity, hospital or other
- Collaborators
- Ligue Tunisienne Anti Rhumatismale
- Study start
- 23 May 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated with biologic for rheumatoid arthritis or spondylitis
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Evolutionary neoplasia at the time of inclusion
- Other associated systemic diseases, except Sjögren's Syndrome
- Consent not obtained
- Pregnant or lactating woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: Up to two years of follow-up
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
5 secondary outcomes
Assessment of Rheumatoid Arthritis Activity
Time frame: At baseline and at two years follow-up
Health Assessment Questionnaire
Time frame: At baseline
Assessment of Spondylitis Fonctional Activity
Time frame: At baseline and at two years follow-up
Assessment of Spondylitis Disease Activity
Time frame: At baseline and at two years follow-up
Assessment of Spondylitis Activity
Time frame: At baseline and at two years follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Social Media Group of the ProjectLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Kochbati, MD study chair
LITAR : Ligue Tunisienne Anti Rhumatismale
Kawther Ben Abdelghani, MD principal investigator
LITAR : Ligue Tunisienne Anti Rhumatismale
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid and Spondylitis, run by Dacima Consulting at 10 sites in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to two years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.