Observational Study in Patients Treated with JAK Inhibitors for Inflammatory Rheumatism (MAJIK)

Last updated: January 20, 2025
Sponsor: Societe Francaise de Rhumatologie
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Rheumatic Fever

Joint Injuries

Treatment

no intervention

Clinical Study ID

NCT04602091
MAJIK Registry
  • Ages > 18
  • All Genders

Study Summary

Janus kinase (JAK) inhibitors are a new class of molecules available to the therapeutic arsenal for chronic inflammatory rheumatic diseases.The tolerance profile of this new class needs to be better defined and its use in real life further established.

The French Society of Rheumatologists intends to coordinate a prospective national registry study for this follow-up.

This registry will include at least 1500 Rheumatoid Arthritis (RA) and 150 patients with psoriatic arthritis from the start of treatment with JAK inhibitor and then followed for 5 years.

This registry is a longitudinal, multicentre, observational registry study. The objective of this national registry is to get a better understanding of the safety profiles of JAK inhibitors and get knowledge of their use in daily practice in order to optimize this use and potentially integrate JAK inhibitors into personalised medicine strategies.

This registry will generate efficacy data, especially therapeutic maintenance, observation, allowing inter-registry comparisons with other biologic compounds in the French population, and can be aggregated with other similar registries in other countries.

Eligibility Criteria

Inclusion

Inclusion criteria

  • Patients older than 18

  • Patient treated with a JAK inhibitor in accordance with EMA, for chronic inflammatory rheumatisms, independent of the therapeutic line

  • Subject who is a member of a social security regime

  • Free, declared, written consent signed by the subject and the investigator on the day of inclusion Exclusion criteria

  • Patient who cannot understand the implications and rules of the study

  • Patient opposition to participating in the study

Study Design

Total Participants: 2300
Treatment Group(s): 1
Primary Treatment: no intervention
Phase:
Study Start date:
October 08, 2019
Estimated Completion Date:
June 30, 2030

Study Description

Design:

This registry is a longitudinal, multicentre, observational registry study, with continuous and ambispective collection of clinical and laboratory data. The patients will be followed for 5 years, regardless of the therapeutic modifications occurring thereafter.

Target population:

Patients initiating JAK inhibitor therapy for inflammatory rheumatic disorder.

Number of patients and centres :

  • The objective is to include, per drug available on the market, at least 300 to 500 patients with RA and at least 100 to 150 patients with psoriatic arthritis. If a JAK inhibitor is approved in a new indication of chronic rheumatic disease by European Medicines Agency (EMA), the number of patients to include for each molecule in this indication will be adjusted as a function of the prevalence/epidemiology of each disease. Products currently available (baricitinib and tofacitinib) will be considered at the start of this registry; then every new indication for an already approved drug or every new drug in the same therapeutic class starting from the date they are placed on the market will be considered.

  • More than 80 centers in France (hospital-based, public and private practice) will participate.

Connect with a study center

  • CH Antibes

    Antibes,
    France

    Site Not Available

  • Private office

    Bayonne,
    France

    Site Not Available

  • CH Franche Comte

    Belfort,
    France

    Site Not Available

  • CHU de Besançon

    Besançon,
    France

    Site Not Available

  • AP-HP Avicenne

    Bobigny,
    France

    Site Not Available

  • CHU de Bordeaux

    Bordeaux,
    France

    Site Not Available

  • CH Bourg-en-Bresse

    Bourg-en-Bresse,
    France

    Site Not Available

  • CHRU Brest

    Brest,
    France

    Site Not Available

  • CHU Caen

    Caen,
    France

    Site Not Available

  • CH Cannes

    Cannes,
    France

    Site Not Available

  • CH Chartres

    Chartres,
    France

    Site Not Available

  • CH Cholet

    Cholet,
    France

    Site Not Available

  • CHU Clermont Ferrand

    Clermont-Ferrand,
    France

    Site Not Available

  • CH Colombes

    Colombes,
    France

    Site Not Available

  • AP-HP Henri Mondor

    Créteil,
    France

    Site Not Available

  • CH Dax

    Dax,
    France

    Site Not Available

  • CH de Dijon

    Dijon,
    France

    Site Not Available

  • CH de Douai

    Douai,
    France

    Site Not Available

  • CHD de Vendee

    La Roche-sur-Yon,
    France

    Site Not Available

  • CH La Rochelle

    La Rochelle,
    France

    Site Not Available

  • CHG Jacques Monod

    Le Havre,
    France

    Site Not Available

  • AP-HP Bicetre

    Le Kremlin-Bicêtre,
    France

    Site Not Available

  • CH Le Mans

    Le Mans,
    France

    Site Not Available

  • CHU Lille

    Lille,
    France

    Site Not Available

  • Private office

    Limoges,
    France

    Site Not Available

  • CH Saint Philibert

    Lomme,
    France

    Site Not Available

  • CHU Lyon

    Lyon,
    France

    Site Not Available

  • Infirmerie protestante de Lyon

    Lyon,
    France

    Site Not Available

  • CHU Marseille Sainte-Marguerite

    Marseille,
    France

    Site Not Available

  • Hôpital Saint Joseph

    Marseille,
    France

    Site Not Available

  • CH Mont de Marsan

    Mont-de-Marsan,
    France

    Site Not Available

  • CHU de Montpellier

    Montpellier,
    France

    Site Not Available

  • CH Morlaix

    Morlaix,
    France

    Site Not Available

  • GH de Mulhouse

    Mulhouse,
    France

    Site Not Available

  • CHU Nantes

    Nantes,
    France

    Site Not Available

  • CH Nevers

    Nevers,
    France

    Site Not Available

  • CHU Nice

    Nice,
    France

    Site Not Available

  • CH Niort

    Niort,
    France

    Site Not Available

  • CH Orleans

    Orléans,
    France

    Site Not Available

  • AP-HP Ambroise Pare

    Paris,
    France

    Site Not Available

  • AP-HP Bichat

    Paris,
    France

    Site Not Available

  • AP-HP Lariboisiere

    Paris,
    France

    Site Not Available

  • AP-HP Pitie-Salpetriere

    Paris,
    France

    Site Not Available

  • AP-HP Saint Antoine

    Paris,
    France

    Site Not Available

  • Hopital La Croix Saint Simon

    Paris,
    France

    Site Not Available

  • Hôpital Cochin

    Paris,
    France

    Site Not Available

  • CH Pau

    Pau,
    France

    Site Not Available

  • CHU Reims

    Reims,
    France

    Site Not Available

  • CHU Rouen

    Rouen,
    France

    Site Not Available

  • CHU de la Reunion

    Saint-Denis,
    France

    Site Not Available

  • CH Bégin

    Saint-Mandé,
    France

    Site Not Available

  • CH Saint Nazaire

    Saint-Nazaire,
    France

    Site Not Available

  • CHU Saint Etienne

    Saint-Étienne,
    France

    Site Not Available

  • CHU Strasbourg

    Strasbourg,
    France

    Site Not Available

  • CHU Toulouse

    Toulouse,
    France

    Site Not Available

  • CHU Tours

    Tours,
    France

    Site Not Available

  • CH Troyes

    Troyes,
    France

    Site Not Available

  • CH Valence

    Valence,
    France

    Site Not Available

  • CH Valenciennes

    Valenciennes,
    France

    Site Not Available

  • Polyclinique Vauban

    Valenciennes,
    France

    Site Not Available

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