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

Rheumatoid Arthritis Clinical Trial

— 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."

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04602091
• Other study ID #: MAJIK Registry
• Status: Recruiting
• Start date: October 8, 2019
• Est. completion date: June 2030

Study information

• Verified date: March 2024
• Source: Societe Francaise de Rhumatologie
• Contact: Sorelle MBOUM
• Phone: +33 (0)158413129
• Email: majik[@]rhumatologie.asso.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2300
• Est. completion date: June 2030
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Collagen Diseases
• Inflammatory Rheumatism
• Psoriatic Arthritis
• Rheumatic Diseases
• Rheumatic Fever
• Rheumatoid Arthritis
• Spondylarthritis
• Spondylitis
• Spondyloarthritis

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
France	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	Hôpital Cochin	Paris
France	Hopital La Croix Saint Simon	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-Étienne
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

Sponsors (2)

Lead Sponsor	Collaborator
Societe Francaise de Rhumatologie	Bordeaux PharmacoEpi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Real-life tolerance of JAK inhibitors	Occurence of adverse events and action taken (temporary or final stop to JAK inhibitor treatment upon the occurrence of adverse event).	From the beginning of the study until the end of the 5 years follow-up
Secondary	Real-life tolerance of JAK inhibitors in sub-groups	Occurence of adverse events and action taken (temporary or final stop to JAK inhibitor treatment upon the occurrence of adverse event), in an older population or presenting with comorbidities	From the beginning of the study until the end of the 5 years follow-up
Secondary	Efficacy of JAK inhibitors	Evaluated using clinical data (list is not exhaustive): number of swelling joints (NAG), number of tender joints (NAD), erythrocyte sedimentation rate (ESR), levels of C-reactive protein (CRP), the visual analogic scale (VAS) for disease activity evaluated by the patient and by the physician.	From the beginning of the study until the end of the 5 years follow-up
Secondary	Comparison of JAK inhibitors efficacy (monotherapy versus combination with DMARDS)	Evaluate the efficacy of JAK inhibitors administered as monotherapy versus combination with a conventional synthetic DMARDs	From the beginning of the study until the end of the 5 years follow-up
Secondary	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
Secondary	Use of JAK inhibitors in current practice	Starting dosage, therapeutic adjustments, etc.	From the beginning of the study until the end of the 5 years follow-up
Secondary	Place of JAK inhibitors in real-life practice in the treatment arsenal for patients with chronic inflammatory rheumatic disorders	Therapeutic history of the patient regarding DMARDs before starting treatment with a JAK inhibitor	From the beginning of the study until the end of the 5 years follow-up
Secondary	Patient reported outcomes: Quality of life	Analyse the effect of JAK inhibitors on patient reported outcomes in regard to quality of life and functional impact : Health Assessment Questionnaire (HAQ) questionnaire	From the beginning of the study until the end of the 5 years follow-up
Secondary	Patient reported outcomes: Acceptance	Analyse the effect of JAK inhibitors on patient reported outcomes in regard to acceptance : treatment acceptance questionnaire	From the beginning of the study until the end of the 5 years follow-up
Secondary	Patient reported outcomes: Compliance	Analyse the effect of JAK inhibitors on patient reported outcomes in regard to Compliance : compliance questionnaire (Morisky-Green self-questionnaire)	From the beginning of the study until the end of the 5 years follow-up
Secondary	Drug interactions	Identify new drug interactions	From the beginning of the study until the end of the 5 years follow-up
Secondary	Analysis if data from a National Health Database (SNIIRAM): demographics	With and without chaining to the patients included in this cohort with the possibility of evaluating demographics	From the beginning of the study until the end of the 5 years follow-up
Secondary	Analysis if data from a National Health Database (SNIIRAM): medical economics	With and without chaining to the patients included in this cohort with the possibility of evaluating medical economics	From the beginning of the study until the end of the 5 years follow-up
Secondary	Analysis if data from a National Health Database (SNIIRAM): compliance	With and without chaining to the patients included in this cohort with the possibility of evaluating compliance	From the beginning of the study until the end of the 5 years follow-up
Secondary	Establishment of an open database	Establish an open database which can be integrated with other national registries with a view toward future international analyses	From the beginning of the study until the end of the 5 years follow-up