French National Registry: ART REGISTRY (Observational Study)

Study Overview
=================
Brief 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. 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

Official Title
-----------------
ART REGISTRY : Rheumatoid Arthritis and Anti-TNF

Conditions
-----------------
RheumatoId Arthritis

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Patient already treated by the same anti-TNF in the past (same drug).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment retention rate on anti-TNF therapy | outcome : 1, 2, 3, 4 and 5-year drug retention rate comparisons : between all the TNF inhibitors | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid arthritis (RA), TNF-alpha inhibitors