French National Registry: ART REGISTRY (Observational Study)

NCT03062865 | Unknown DMC

• 1 other identifier: ART
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

RheumatoId Arthritis

Keywords

Rheumatoid arthritis (RA); TNF-alpha inhibitors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Treatment retention rate on anti-TNF therapy

  From the beginning of the study until the end of the 5 years follow-up

• Number of patients receiving each of the drugs

  From the beginning of the study until the end of the 5 years follow-up

• - Number and nature of biologics previously received

  From the beginning of the study until the end of the 5 years follow-up

• rate of serious and opportunistic infections (overall and subtypes)

  From the beginning of the study until the end of the 5 years follow-up

• Rate of malignancies (overall and subtypes)

  From the beginning of the study until the end of the 5 years follow-up

Interventions

No intervention OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patient already treated by the same anti-TNF in the past (same drug).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Societe Francaise de Rhumatologie: collaborator

Study Sites (1)

Hopital Bicêtre

Le Kremlin-Bicêtre, Val De Marne, 94270, France

RECRUITING

Related Publications (1)

• Nguyen Y, Baron G, Hamamouche N, Belkhir R, Miconnet S, Soubrier M, Hostachy C, Thevenot P, Basch A, Truchetet ME, Claudepierre P, Dernis E, Marotte H, Flipo RM, Brocq O, Morel J, Fautrel B, Salliot C, Saraux A, Leske C, Schaeverbeke T, Ravaud P, Mariette X, Ruyssen-Witrand A, Seror R; ART Study Group section sign. Do SMS/e-mail reminders increase influenza vaccination of rheumatoid arthritis patients under anti-TNF: a nested randomized controlled trial in the ART e-cohort. Rheumatology (Oxford). 2025 May 1;64(5):2496-2504. doi: 10.1093/rheumatology/keae599.

  PMID: 39576675 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Raphaele SEROR

  SFR/AP-HP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raphaele SEROR

CONTACT

+33 (0)1 45 21 37 59; raphaele.seror@aphp.fr

Adeline Ruyssen-Witrand

CONTACT

05-61-77-55-55/05-61-77-69-76; ruyssen-witrand.a@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: February 24, 2017
• Study Start: November 1, 2016
• Primary Completion: November 1, 2024
• Study Completion: February 1, 2025
• Last Updated: February 24, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)