Clinical trial NCT03062865: French National Registry: ART REGISTRY (Observational Study)
Official title: "ART REGISTRY : Rheumatoid Arthritis and Anti-TNF"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: RheumatoId Arthritis
Keywords: Rheumatoid arthritis (RA)
TNF-alpha inhibitors
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Societe Francaise de Rhumatologie
First posted: 2017-02-24
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Target population :

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

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

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).

Primary outcomes:
measure: Drug (anti TNF inhibitors) retention rate
timeFrame: From the beginning of the study until the end of the 5 years follow-up
Secondary outcomes:
measure: Treatment retention rate on anti-TNF therapy
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Number of patients receiving each of the drugs
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: - Number and nature of biologics previously received
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: rate of serious and opportunistic infections (overall and subtypes)
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Rate of malignancies (overall and subtypes)
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Rate of cardiovascular events (overall and subtypes)
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: rate of serious adverse events (overall and subtypes)
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Rate of surgery and surgical complications (overall and subtypes)
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Comparison with the other french biotherapy registries with similar methodology
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Establishment of a database accessible to all participating clinicians in the collection for the purpose of making complementary analyses.
timeFrame: From the beginning of the study until the end of the 5 years follow-up
Other outcomes:
Locations:
city: Le Kremlin Bicêtre
country: France
facility: Hopital Bicêtre
state: Val De Marne
Study officials:
affiliation: SFR/AP-HP
name: Raphaele SEROR
role: PRINCIPAL_INVESTIGATOR
References: