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

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ClinicalTrials.gov Identifier: NCT03062865
Recruitment Status : Recruiting
First Posted : February 24, 2017
Last Update Posted : February 24, 2017
Sponsor:
Collaborator:
Societe Francaise de Rhumatologie
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
RheumatoId Arthritis 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


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: "ART REGISTRY : Rheumatoid Arthritis and Anti-TNF"
Study Start Date : November 2016
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Drug (anti TNF inhibitors) retention rate [ Time Frame: 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 :
  1. Treatment retention rate on anti-TNF therapy [ Time Frame: 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

  2. Number of patients receiving each of the drugs [ Time Frame: From the beginning of the study until the end of the 5 years follow-up ]
    Place of anti-TNF agents among the therapeutic choices

  3. - Number and nature of biologics previously received [ Time Frame: From the beginning of the study until the end of the 5 years follow-up ]
    Place of anti-TNF agents among the therapeutic choices

  4. rate of serious and opportunistic infections (overall and subtypes) [ Time Frame: From the beginning of the study until the end of the 5 years follow-up ]
    Safety Outcome

  5. Rate of malignancies (overall and subtypes) [ Time Frame: From the beginning of the study until the end of the 5 years follow-up ]
    Safety Outcome

  6. Rate of cardiovascular events (overall and subtypes) [ Time Frame: From the beginning of the study until the end of the 5 years follow-up ]
    Safety Outcome

  7. rate of serious adverse events (overall and subtypes) [ Time Frame: From the beginning of the study until the end of the 5 years follow-up ]
    Safety Outcome

  8. Rate of surgery and surgical complications (overall and subtypes) [ Time Frame: From the beginning of the study until the end of the 5 years follow-up ]
    Safety Outcome

  9. Comparison with the other french biotherapy registries with similar methodology [ Time Frame: 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

  10. Establishment of a database accessible to all participating clinicians in the collection for the purpose of making complementary analyses. [ Time Frame: From the beginning of the study until the end of the 5 years follow-up ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Target population :

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

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062865


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

Locations
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France
Hopital Bicêtre Recruiting
Le Kremlin Bicêtre, Val De Marne, France, 94270
Contact: Raphaele SEROR    +33 (0)1 45 21 37 59    raphaele.seror@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Societe Francaise de Rhumatologie
Investigators
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Principal Investigator: Raphaele SEROR SFR/AP-HP

Additional Information:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03062865     History of Changes
Other Study ID Numbers: ART
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Rheumatoid arthritis (RA)
TNF-alpha inhibitors
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases