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Clinical Trials in France / NCT04602091
Active, not recruiting Observational

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

NCT04602091 · tracked via the Priya Life Science France tracker
Sponsor
Societe Francaise de Rhumatologie
Phase
Observational
Started
2019-10-08
Last updated
2025-01-23

Condition(s) studied

Rheumatoid ArthritisInflammatory RheumatismPsoriatic ArthritisSpondyloarthritis

Investigational drug(s) / intervention(s)

no intervention

no intervention: no intervention

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (60)

FacilityCityRegionStatus
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

+ 20 more sites — see the full list on the official registry below.

More Societe Francaise de Rhumatologie trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04602091 on ClinicalTrials.gov ↗ ← All trials in France