French National Registry: ART REGISTRY (Observational Study)

Recruiting

• Conditions: RheumatoId Arthritis

• Registration Number: NCT03062865
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study Start: 2016-11
• Status Verified: 2017-01
• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-02-20
• Last Update Submitted: 2017-02-20
• Study First Posted: 2017-02-24
• Last Update Posted: 2017-02-24
• Primary Completion: 2024-11
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Drug (anti TNF inhibitors) retention rate	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 Outcome Measures

Name	Time	Method
Treatment retention rate on anti-TNF therapy	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	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	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)	From the beginning of the study until the end of the 5 years follow-up	Safety Outcome
Rate of malignancies (overall and subtypes)	From the beginning of the study until the end of the 5 years follow-up	Safety Outcome
Rate of cardiovascular events (overall and subtypes)	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)	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)	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	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.	From the beginning of the study until the end of the 5 years follow-up

Trial Locations

Locations (1)

Hopital Bicêtre; 🇫🇷 Le Kremlin Bicêtre, Val De Marne, France