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| Name | Class |
|---|---|
| Societe Francaise de Rhumatologie | OTHER |
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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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the beginning of the study until the end of the 5 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment retention rate on anti-TNF therapy |
| From the beginning of the study until the end of the 5 years follow-up |
| Number of patients receiving each of the drugs |
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Inclusion Criteria:
Exclusion Criteria:
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Target population :
Patients with rheumatoid arthritis initiating anti-TNF therapy, whatever the treatment line
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raphaele SEROR | Contact | +33 (0)1 45 21 37 59 | raphaele.seror@aphp.fr | |
| Adeline Ruyssen-Witrand | Contact | 05-61-77-55-55/05-61-77-69-76 | ruyssen-witrand.a@chu-toulouse.fr |
| Name | Affiliation | Role |
|---|---|---|
| Raphaele SEROR | SFR/AP-HP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Bicêtre | Recruiting | Le Kremlin-Bicêtre | Val De Marne | 94270 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39576675 | Derived | 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. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Place of anti-TNF agents among the therapeutic choices |
| 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 | 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 | From the beginning of the study until the end of the 5 years follow-up |
| Rate of malignancies (overall and subtypes) | Safety Outcome | From the beginning of the study until the end of the 5 years follow-up |
| Rate of cardiovascular events (overall and subtypes) | Safety Outcome | 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 | 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 | 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 | 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. | From the beginning of the study until the end of the 5 years follow-up |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |