French National Registry: ART REGISTRY (Observational Study) (ART)

"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.

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.

Study Overview

• Status: Recruiting
• Conditions: RheumatoId Arthritis
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Raphaele SEROR; Phone Number: +33 (0)1 45 21 37 59; Email: raphaele.seror@aphp.fr
• Study Contact Backup: Name: Adeline Ruyssen-Witrand; Phone Number: 05-61-77-55-55/05-61-77-69-76; Email: ruyssen-witrand.a@chu-toulouse.fr

Study Locations

• France
  • Val De Marne
    • Le Kremlin Bicêtre, Val De Marne, France, 94270
      • Recruiting
      • Hôpital Bicêtre
      • Contact: Raphaele SEROR; Phone Number: +33 (0)1 45 21 37 59; Email: raphaele.seror@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Target population :

Patients with rheumatoid arthritis initiating anti-TNF therapy, whatever the treatment line

Description

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).

Study Plan

How is the study designed?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Societe Francaise de Rhumatologie
• Investigators: Principal Investigator: Raphaele SEROR, SFR/AP-HP

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 20, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Rheumatoid arthritis (RA); TNF-alpha inhibitors
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: ART

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO