Observational Study in Patients Treated With JAK Inhibitors for Inflammatory Rheumatism (MAJIK)
NCT ID: NCT04602091
Last Updated: 2025-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
2300 participants
OBSERVATIONAL
2019-10-08
2030-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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no intervention
no intervention
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Patient opposition to participating in the study
18 Years
ALL
No
Sponsors
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Bordeaux PharmacoEpi
OTHER
Societe Francaise de Rhumatologie
OTHER
Responsible Party
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Principal Investigators
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Marie-Elise TRUCHETET
Role: PRINCIPAL_INVESTIGATOR
CHU de Bordeaux - Pellegrin
Jerôme AVOUAC
Role: PRINCIPAL_INVESTIGATOR
AP-HP Hôpital Cochin
Clément PRATI
Role: PRINCIPAL_INVESTIGATOR
CHRU de Besançon
Locations
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CH Antibes
Antibes, , France
Private office
Bayonne, , France
CH Franche Comte
Belfort, , France
CHU de Besançon
Besançon, , France
AP-HP Avicenne
Bobigny, , France
CHU de Bordeaux
Bordeaux, , France
CH Bourg-en-Bresse
Bourg-en-Bresse, , France
CHRU Brest
Brest, , France
CHU Caen
Caen, , France
CH Cannes
Cannes, , France
CH Chartres
Chartres, , France
CH Cholet
Cholet, , France
CHU Clermont Ferrand
Clermont-Ferrand, , France
CH Colombes
Colombes, , France
AP-HP Henri Mondor
Créteil, , France
CH Dax
Dax, , France
CH de Dijon
Dijon, , France
CH de Douai
Douai, , France
CHD de Vendee
La Roche-sur-Yon, , France
CH La Rochelle
La Rochelle, , France
CHG Jacques Monod
Le Havre, , France
AP-HP Bicetre
Le Kremlin-Bicêtre, , France
CH Le Mans
Le Mans, , France
CHU Lille
Lille, , France
Private office
Limoges, , France
CH Saint Philibert
Lomme, , France
CHU Lyon
Lyon, , France
Infirmerie protestante de Lyon
Lyon, , France
CHU Marseille Sainte-Marguerite
Marseille, , France
Hôpital Saint Joseph
Marseille, , France
CH Mont de Marsan
Mont-de-Marsan, , France
CHU de Montpellier
Montpellier, , France
CH Morlaix
Morlaix, , France
GH de Mulhouse
Mulhouse, , France
CHU Nantes
Nantes, , France
CH Nevers
Nevers, , France
CHU Nice
Nice, , France
CH Niort
Niort, , France
CH Orleans
Orléans, , France
AP-HP Ambroise Pare
Paris, , France
AP-HP Bichat
Paris, , France
AP-HP Lariboisiere
Paris, , France
AP-HP Pitie-Salpetriere
Paris, , France
AP-HP Saint Antoine
Paris, , France
Hopital La Croix Saint Simon
Paris, , France
Hôpital Cochin
Paris, , France
CH Pau
Pau, , France
CHU Reims
Reims, , France
CHU Rouen
Rouen, , France
CHU de la Reunion
Saint-Denis, , France
CHU Saint Etienne
Saint-Etienne, , France
CH Bégin
Saint-Mandé, , France
CH Saint Nazaire
Saint-Nazaire, , France
CHU Strasbourg
Strasbourg, , France
CHU Toulouse
Toulouse, , France
CHU Tours
Tours, , France
CH Troyes
Troyes, , France
CH Valence
Valence, , France
CH Valenciennes
Valenciennes, , France
Polyclinique Vauban
Valenciennes, , France
Countries
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Other Identifiers
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MAJIK Registry
Identifier Type: -
Identifier Source: org_study_id
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