French National Registry: ART REGISTRY (Observational Study)

RheumatoId Arthritis Clinical Trial

— ART  

Official title:

"ART REGISTRY : Rheumatoid Arthritis and Anti-TNF"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03062865
• Other study ID #: ART
• Status: Recruiting
• Phase: N/A
• First received: January 13, 2017
• Last updated: February 20, 2017
• Start date: November 2016
• Est. completion date: February 2025

Study information

• Verified date: January 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Raphaele SEROR
• Phone: +33 (0)1 45 21 37 59
• Email: raphaele.seror[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: February 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• RheumatoId Arthritis

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
France	Hopital Bicêtre	Le Kremlin Bicêtre	Val De Marne

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Société Française de Rhumatologie (SFR)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	- 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
Secondary	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
Secondary	Rate of malignancies (overall and subtypes)	Safety Outcome	From the beginning of the study until the end of the 5 years follow-up
Secondary	Rate of cardiovascular events (overall and subtypes)	Safety Outcome	From the beginning of the study until the end of the 5 years follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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