French National Registry: ART REGISTRY (Observational Study)

Overview

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.

Full Title of Study: “”ART REGISTRY : Rheumatoid Arthritis and Anti-TNF””

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2024

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

Interventions

  • Other: No intervention

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Treatment retention rate on anti-TNF therapy
    • Time Frame: From the beginning of the study until the end of the 5 years follow-up
    • outcome : 1, 2, 3, 4 and 5-year drug retention rate comparisons : between all the TNF inhibitors
  • 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
    • Place of anti-TNF agents among the therapeutic choices
  • – Number and nature of biologics previously received
    • Time Frame: From the beginning of the study until the end of the 5 years follow-up
    • Place of anti-TNF agents among the therapeutic choices
  • 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
    • Safety Outcome
  • Rate of malignancies (overall and subtypes)
    • Time Frame: From the beginning of the study until the end of the 5 years follow-up
    • Safety Outcome
  • Rate of cardiovascular events (overall and subtypes)
    • Time Frame: From the beginning of the study until the end of the 5 years follow-up
    • Safety Outcome
  • 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
    • Safety Outcome
  • 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
    • Safety Outcome
  • 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
    • – comparisons of the following outcomes: drug retention rate, rate of serious infections, rate of malignancies, rate of serious adverse events, rate of cardiovascular events
  • 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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Collaborator
    • Societe Francaise de Rhumatologie
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Raphaele SEROR, Principal Investigator, SFR/AP-HP
  • Overall Contact(s)
    • Raphaele SEROR, +33 (0)1 45 21 37 59, raphaele.seror@aphp.fr

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