Observational Study in Patients Treated With JAK Inhibitors for Inflammatory Rheumatism (MAJIK)
MAJIK
JAKINIB Study: " 'Observational', Multicentre Trial Collecting Prospective and On-going Clinical and Laboratory Data for Patients Treated With JAK Inhibitors for Inflammatory Rheumatism According to EMA."
1 other identifier
observational
2,300
1 country
60
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Longer than P75 for all trials
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 8, 2019
CompletedFirst Submitted
Initial submission to the registry
October 14, 2020
CompletedFirst Posted
Study publicly available on registry
October 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
January 23, 2025
January 1, 2025
8.2 years
October 14, 2020
January 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Therapeutic maintenance of JAK inhibitors
The therapeutic maintenance will be measured by the retention rate ie the percentage of patients remaining treated by JAK inhibitors.
From the beginning of the study up to Year 1
Secondary Outcomes (15)
Real-life tolerance of JAK inhibitors
From the beginning of the study until the end of the 5 years follow-up
Real-life tolerance of JAK inhibitors in sub-groups
From the beginning of the study until the end of the 5 years follow-up
Efficacy of JAK inhibitors
From the beginning of the study until the end of the 5 years follow-up
Comparison of JAK inhibitors efficacy (monotherapy versus combination with DMARDS)
From the beginning of the study until the end of the 5 years follow-up
Efficacy of JAK inhibitors dose (full doses versus half doses)
From the beginning of the study until the end of the 5 years follow-up
- +10 more secondary outcomes
Interventions
no intervention
Eligibility Criteria
French patients treated for chronic inflammatory rheumatic disorders according to EMA.
You may qualify if:
- 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
You may not qualify if:
- Patient who cannot understand the implications and rules of the study
- Patient opposition to participating in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Societe Francaise de Rhumatologielead
- Bordeaux PharmacoEpicollaborator
Study Sites (60)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie-Elise TRUCHETET
CHU de Bordeaux - Pellegrin
- PRINCIPAL INVESTIGATOR
Jerôme AVOUAC
AP-HP Hôpital Cochin
- PRINCIPAL INVESTIGATOR
Clément PRATI
CHRU de Besançon
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
October 14, 2020
First Posted
October 26, 2020
Study Start
October 8, 2019
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
June 1, 2030
Last Updated
January 23, 2025
Record last verified: 2025-01