Clinical trial NCT04602091: Observational Study in Patients Treated With JAK Inhibitors for Inflammatory Rheumatism (MAJIK)
Official title: 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."
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rheumatoid Arthritis
Inflammatory Rheumatism
Psoriatic Arthritis
Spondyloarthritis
Lead sponsor: Societe Francaise de Rhumatologie
Sponsor class: OTHER
Collaborators: name: Bordeaux PharmacoEpi
First posted: 2020-10-26
Enrollment: 2300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: French patients treated for chronic inflammatory rheumatic disorders according to EMA.

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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: Therapeutic maintenance of JAK inhibitors
timeFrame: From the beginning of the study up to Year 1
Secondary outcomes:
measure: Real-life tolerance of JAK inhibitors
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Real-life tolerance of JAK inhibitors in sub-groups
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Efficacy of JAK inhibitors
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Comparison of JAK inhibitors efficacy (monotherapy versus combination with DMARDS)
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Efficacy of JAK inhibitors dose (full doses versus half doses)
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Use of JAK inhibitors in current practice
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Place of JAK inhibitors in real-life practice in the treatment arsenal for patients with chronic inflammatory rheumatic disorders
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Patient reported outcomes: Quality of life
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Patient reported outcomes: Acceptance
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Patient reported outcomes: Compliance
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Drug interactions
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Analysis if data from a National Health Database (SNIIRAM): demographics
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Analysis if data from a National Health Database (SNIIRAM): medical economics
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Analysis if data from a National Health Database (SNIIRAM): compliance
timeFrame: From the beginning of the study until the end of the 5 years follow-up
measure: Establishment of an open database
timeFrame: From the beginning of the study until the end of the 5 years follow-up
Other outcomes:
Locations:
city: Antibes
country: France
facility: CH Antibes
city: Bayonne
country: France
facility: Private office
city: Belfort
country: France
facility: CH Franche Comte
city: Besançon
country: France
facility: CHU de Besançon
city: Bobigny
country: France
facility: AP-HP Avicenne
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Bourg-en-Bresse
country: France
facility: CH Bourg-en-Bresse
city: Brest
country: France
facility: CHRU Brest
city: Caen
country: France
facility: CHU Caen
city: Cannes
country: France
facility: CH Cannes
city: Chartres
country: France
facility: CH Chartres
city: Cholet
country: France
facility: CH Cholet
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand
city: Colombes
country: France
facility: CH Colombes
city: Créteil
country: France
facility: AP-HP Henri Mondor
city: Dax
country: France
facility: CH Dax
city: Dijon
country: France
facility: CH de Dijon
city: Douai
country: France
facility: CH de Douai
city: La Roche-sur-Yon
country: France
facility: CHD de Vendee
city: La Rochelle
country: France
facility: CH La Rochelle
city: Le Havre
country: France
facility: CHG Jacques Monod
city: Le Kremlin-Bicêtre
country: France
facility: AP-HP Bicetre
city: Le Mans
country: France
facility: CH Le Mans
city: Lille
country: France
facility: CHU Lille
city: Limoges
country: France
facility: Private office
city: Lomme
country: France
facility: CH Saint Philibert
city: Lyon
country: France
facility: CHU Lyon
city: Lyon
country: France
facility: Infirmerie protestante de Lyon
city: Marseille
country: France
facility: CHU Marseille Sainte-Marguerite
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Mont-de-Marsan
country: France
facility: CH Mont de Marsan
city: Montpellier
country: France
facility: CHU de Montpellier
city: Morlaix
country: France
facility: CH Morlaix
city: Mulhouse
country: France
facility: GH de Mulhouse
city: Nantes
country: France
facility: CHU Nantes
city: Nevers
country: France
facility: CH Nevers
city: Nice
country: France
facility: CHU Nice
city: Niort
country: France
facility: CH Niort
city: Orléans
country: France
facility: CH Orleans
city: Paris
country: France
facility: AP-HP Ambroise Pare
city: Paris
country: France
facility: AP-HP Bichat
city: Paris
country: France
facility: AP-HP Lariboisiere
city: Paris
country: France
facility: AP-HP Pitie-Salpetriere
city: Paris
country: France
facility: AP-HP Saint Antoine
city: Paris
country: France
facility: Hopital La Croix Saint Simon
city: Paris
country: France
facility: Hôpital Cochin
city: Pau
country: France
facility: CH Pau
city: Reims
country: France
facility: CHU Reims
city: Rouen
country: France
facility: CHU Rouen
city: Saint-Denis
country: France
facility: CHU de la Reunion
city: Saint-Mandé
country: France
facility: CH Bégin
city: Saint-Nazaire
country: France
facility: CH Saint Nazaire
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU Tours
city: Troyes
country: France
facility: CH Troyes
city: Valence
country: France
facility: CH Valence
city: Valenciennes
country: France
facility: CH Valenciennes
city: Valenciennes
country: France
facility: Polyclinique Vauban
Study officials:
affiliation: CHU de Bordeaux - Pellegrin
name: Marie-Elise TRUCHETET
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP Hôpital Cochin
name: Jerôme AVOUAC
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU de Besançon
name: Clément PRATI
role: PRINCIPAL_INVESTIGATOR
References: