RheumatoId ArthritisARTNCT03062865
French National Registry: ART REGISTRY (Observational Study)
An observational study of RheumatoId Arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Rheumatoid arthritis (RA) is a complex and multifactorial autoimmune disease. The biological treatments that are currently available for the treatment of RA are the TNF-alpha inhibitors. Tumor necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RheumatoId Arthritis
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2016to Feb 2025
- How long will I take part?
- 5 Years
- 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: Target population : Patients with rheumatoid arthritis initiating anti-TNF therapy, whatever the treatment line
Who may be able to join
- Adult patients with RA,
- Patient in whom the specialist physician decides to start treatment with an anti-TNF drug, regardless of the treatment line and regardless of the anti-TNF, including infliximab, adalimumab, etanercept, certolizumab and golimumab, and their respective biosimilar according to their arrival on the market
- Clinicians (hospital-based and private practice) who agree to adhere to the yearly renewal of the hospital prescription
Who cannot join
- Patient already treated by the same anti-TNF in the past (same drug).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Bicêtre
Le Kremlin-Bicêtre, Val De Marne, 94270
Raphaele SEROR, +33 (0)1 45 21 37 59, raphaele.seror@aphp.fr
About this study
Official title: "ART REGISTRY : Rheumatoid Arthritis and Anti-TNF"
Rheumatoid arthritis (RA) is a complex and multifactorial autoimmune disease. The biological treatments that are currently available for the treatment of RA are the TNF-alpha inhibitors. Tumor necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid arthritis. The anti-TNFs were the first to enter the market, and they revolutionised the prognoses of patients with RA. They remain the most common first-line biotherapy and are the most used at this time.
The French Society of Rheumatologists intends to coordinate a prospective national registry study for this follow-up.
Read more
This registry will include 1500 RA patients from the start of treatment with anti-TNF-α and then followed for 5 years, regardless of the therapeutic modifications occurring thereafter.
This registry is an observational, multicentre, longitudinal, prospective registry study The objectives of this registry is to contribute 1) to evaluate the therapeutic management of patients; and 2) to improve this therapeutic management.
Read the detailed description
Design: Observational, multicentre, longitudinal, prospective registry Primary objective: To evaluate the real life efficacy and safety of anti-TNF inhibitors in patients with RA using a prospective national registry.
Target population: Patients initiating anti-TNF therapy for RA (including infliximab, adalimumab, etanercept, certolizumab and golimumab, and their respective biosimilar according to their arrival on the market) Number of patients and centres : More than 80 centers in France (hospital-based, public and private practice) Recruitment period: 3 years Follow-up: 5 years
- Conditions
- RheumatoId Arthritis
- Being tested
- No intervention
- Keywords
- Rheumatoid arthritis (RA), TNF-alpha inhibitors
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug (anti TNF inhibitors) retention rate
Primary outcome will be 5-year drug retention, this rate will be compared between the different drugs to assess real life efficacy of anti-TNF inhibitors in patients with RA
Measured: From the beginning of the study until the end of the 5 years follow-up
Secondary outcomes (10)
Treatment retention rate on anti-TNF therapy
- outcome : 1, 2, 3, 4 and 5-year drug retention rate
- comparisons : between all the TNF inhibitors
Measured: From the beginning of the study until the end of the 5 years follow-up
Number of patients receiving each of the drugs
Place of anti-TNF agents among the therapeutic choices
Measured: From the beginning of the study until the end of the 5 years follow-up
- Number and nature of biologics previously received
Place of anti-TNF agents among the therapeutic choices
Measured: From the beginning of the study until the end of the 5 years follow-up
rate of serious and opportunistic infections (overall and subtypes)
Safety Outcome
Measured: From the beginning of the study until the end of the 5 years follow-up
Rate of malignancies (overall and subtypes)
Safety Outcome
Measured: From the beginning of the study until the end of the 5 years follow-up
Rate of cardiovascular events (overall and subtypes)
Safety Outcome
Measured: From the beginning of the study until the end of the 5 years follow-up
rate of serious adverse events (overall and subtypes)
Safety Outcome
Measured: From the beginning of the study until the end of the 5 years follow-up
Rate of surgery and surgical complications (overall and subtypes)
Safety Outcome
Measured: From the beginning of the study until the end of the 5 years follow-up
Comparison with the other french biotherapy registries with similar methodology
- comparisons of the following outcomes: drug retention rate, rate of serious infections, rate of malignancies, rate of serious adverse events, rate of cardiovascular events
Measured: From the beginning of the study until the end of the 5 years follow-up
Establishment of a database accessible to all participating clinicians in the collection for the purpose of making complementary analyses.
Measured: From the beginning of the study until the end of the 5 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 posted24 Feb 2017
- Study startNov 2016
- Primary completionNov 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RheumatoId ArthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 1,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Societe Francaise de Rhumatologie
- Responsible party
- Sponsor
- Investigators
- Raphaele SEROR, Principal investigator, SFR/AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062865
- Sponsor's protocol ID
- ART
- Acronym
- ART
- Status last verified
- Jan 2017
- First submitted
- 13 Jan 2017
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Nguyen Y, Baron G, Hamamouche N, Belkhir R, Miconnet S, Soubrier M, Hostachy C, Thevenot P, Basch A, Truchetet ME, Claudepierre P, Dernis E, Marotte H, Flipo RM, Brocq O, Morel J, Fautrel B, Salliot C, Saraux A, Leske C, Schaeverbeke T, Ravaud P, Mariette X, Ruyssen-Witrand A, Seror R; ART Study Group section sign. Do SMS/e-mail reminders increase influenza vaccination of rheumatoid arthritis patients under anti-TNF: a nested randomized controlled trial in the ART e-cohort. Rheumatology (Oxford). 2025 May 1;64(5):2496-2504. doi: 10.1093/rheumatology/keae599.
PubMed 39576675
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "ART REGISTRY : Rheumatoid Arthritis and Anti-TNF"
- ClinicalTrials.gov ID
- NCT03062865
- Acronym / sponsor ID
- ART / ART
- Conditions
- RheumatoId Arthritis
- Keywords
- Rheumatoid arthritis (RA), TNF-alpha inhibitors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Societe Francaise de Rhumatologie
- Study start
- Nov 2016
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 24 Feb 2017 (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.
Rheumatoid arthritis (RA) is a complex and multifactorial autoimmune disease. The biological treatments that are currently available for the treatment of RA are the TNF-alpha inhibitors. Tumor necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid arthritis. The anti-TNFs were the first to enter the market, and they revolutionised the prognoses of patients with RA. They remain the most common first-line biotherapy and are the most used at this time.
The French Society of Rheumatologists intends to coordinate a prospective national registry study for this follow-up.
This registry will include 1500 RA patients from the start of treatment with anti-TNF-α and then followed for 5 years, regardless of the therapeutic modifications occurring thereafter.
This registry is an observational, multicentre, longitudinal, prospective registry study The objectives of this registry is to contribute 1) to evaluate the therapeutic management of patients; and 2) to improve this therapeutic management.
Detailed description
Design: Observational, multicentre, longitudinal, prospective registry Primary objective: To evaluate the real life efficacy and safety of anti-TNF inhibitors in patients with RA using a prospective national registry.
Target population: Patients initiating anti-TNF therapy for RA (including infliximab, adalimumab, etanercept, certolizumab and golimumab, and their respective biosimilar according to their arrival on the market) Number of patients and centres : More than 80 centers in France (hospital-based, public and private practice) Recruitment period: 3 years Follow-up: 5 years
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Target population : Patients with rheumatoid arthritis initiating anti-TNF therapy, whatever the treatment line
Key inclusion criteria (3 listed)
- Adult patients with RA,
- Patient in whom the specialist physician decides to start treatment with an anti-TNF drug, regardless of the treatment line and regardless of the anti-TNF, including infliximab, adalimumab, etanercept, certolizumab and golimumab, and their respective biosimilar according to their arrival on the market
- Clinicians (hospital-based and private practice) who agree to adhere to the yearly renewal of the hospital prescription
Key exclusion criteria (1 listed)
- Patient already treated by the same anti-TNF in the past (same drug).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | – |
Primary outcome
Drug (anti TNF inhibitors) retention rate
Time frame: From the beginning of the study until the end of the 5 years follow-up
Primary outcome will be 5-year drug retention, this rate will be compared between the different drugs to assess real life efficacy of anti-TNF inhibitors in patients with RA
10 secondary outcomes
Treatment retention rate on anti-TNF therapy
Time frame: From the beginning of the study until the end of the 5 years follow-up
Number of patients receiving each of the drugs
Time frame: From the beginning of the study until the end of the 5 years follow-up
- Number and nature of biologics previously received
Time frame: From the beginning of the study until the end of the 5 years follow-up
rate of serious and opportunistic infections (overall and subtypes)
Time frame: From the beginning of the study until the end of the 5 years follow-up
Rate of malignancies (overall and subtypes)
Time frame: From the beginning of the study until the end of the 5 years follow-up
Rate of cardiovascular events (overall and subtypes)
Time frame: From the beginning of the study until the end of the 5 years follow-up
rate of serious adverse events (overall and subtypes)
Time frame: From the beginning of the study until the end of the 5 years follow-up
Rate of surgery and surgical complications (overall and subtypes)
Time frame: From the beginning of the study until the end of the 5 years follow-up
Comparison with the other french biotherapy registries with similar methodology
Time frame: From the beginning of the study until the end of the 5 years follow-up
Establishment of a database accessible to all participating clinicians in the collection for the purpose of making complementary analyses.
Time frame: From the beginning of the study until the end of the 5 years follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Derived from this study: PubMed 39576675Nguyen Y, Baron G, Hamamouche N, Belkhir R, Miconnet S, Soubrier M, Hostachy C, Thevenot P, Basch A, Truchetet ME, Claudepierre P, Dernis E, Marotte H, Flipo RM, Brocq O, Morel J, Fautrel B, Salliot C, Saraux A, Leske C, Schaeverbeke T, Ravaud P, Mariette X, Ruyssen-Witrand A, Seror R; ART Study Group section sign. Do SMS/e-mail reminders increase influenza vaccination of rheumatoid arthritis patients under anti-TNF: a nested randomized controlled trial in the ART e-cohort. Rheumatology (Oxford). 2025 May 1;64(5):2496-2504. doi: 10.1093/rheumatology/keae599.
- Individual participant dataSharing planned: No
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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.
Raphaele SEROR principal investigator
SFR/AP-HP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RheumatoId Arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raphaele SEROR (+33 (0)1 45 21 37 59, raphaele.seror@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug (anti TNF inhibitors) retention rate (time frame: From the beginning of the study until the end of the 5 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03062865, which also lists 1 linked publication.
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 24 Feb 2017.