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

Active, not recruiting

• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Spondyloarthritis; Inflammatory Rheumatism

• Registration Number: NCT04602091
• Lead Sponsor: Societe Francaise de Rhumatologie

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.

Study Timeline

• Study Start: 2019-10-08
• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-23
• Primary Completion: 2027-12
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Therapeutic maintenance of JAK inhibitors	From the beginning of the study up to Year 1	The therapeutic maintenance will be measured by the retention rate ie the percentage of patients remaining treated by JAK inhibitors.

Secondary Outcome Measures

Name	Time	Method
Real-life tolerance of JAK inhibitors	From the beginning of the study until the end of the 5 years follow-up	Occurence of adverse events and action taken (temporary or final stop to JAK inhibitor treatment upon the occurrence of adverse event).
Patient reported outcomes: Quality of life	From the beginning of the study until the end of the 5 years follow-up	Analyse the effect of JAK inhibitors on patient reported outcomes in regard to quality of life and functional impact : Health Assessment Questionnaire (HAQ) questionnaire
Analysis if data from a National Health Database (SNIIRAM): compliance	From the beginning of the study until the end of the 5 years follow-up	With and without chaining to the patients included in this cohort with the possibility of evaluating compliance
Establishment of an open database	From the beginning of the study until the end of the 5 years follow-up	Establish an open database which can be integrated with other national registries with a view toward future international analyses
Efficacy of JAK inhibitors	From the beginning of the study until the end of the 5 years follow-up	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.
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	Evaluate the efficacy of JAK inhibitors administered as monotherapy versus combination with a conventional synthetic DMARDs
Use of JAK inhibitors in current practice	From the beginning of the study until the end of the 5 years follow-up	Starting dosage, therapeutic adjustments, etc.
Analysis if data from a National Health Database (SNIIRAM): demographics	From the beginning of the study until the end of the 5 years follow-up	With and without chaining to the patients included in this cohort with the possibility of evaluating demographics
Patient reported outcomes: Acceptance	From the beginning of the study until the end of the 5 years follow-up	Analyse the effect of JAK inhibitors on patient reported outcomes in regard to acceptance : treatment acceptance questionnaire
Drug interactions	From the beginning of the study until the end of the 5 years follow-up	Identify new drug interactions
Analysis if data from a National Health Database (SNIIRAM): medical economics	From the beginning of the study until the end of the 5 years follow-up	With and without chaining to the patients included in this cohort with the possibility of evaluating medical economics
Real-life tolerance of JAK inhibitors in sub-groups	From the beginning of the study until the end of the 5 years follow-up	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
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
Patient reported outcomes: Compliance	From the beginning of the study until the end of the 5 years follow-up	Analyse the effect of JAK inhibitors on patient reported outcomes in regard to Compliance : compliance questionnaire (Morisky-Green self-questionnaire)
Place of JAK inhibitors in real-life practice in the treatment arsenal for patients with chronic inflammatory rheumatic disorders	From the beginning of the study until the end of the 5 years follow-up	Therapeutic history of the patient regarding DMARDs before starting treatment with a JAK inhibitor

Trial Locations

Locations (59)

CH Colombes; 🇫🇷 Colombes, France

AP-HP Henri Mondor; 🇫🇷 Créteil, France

CH Dax; 🇫🇷 Dax, France

CH de Dijon; 🇫🇷 Dijon, France

CH de Douai; 🇫🇷 Douai, France

CHU Nantes; 🇫🇷 Nantes, France

CH Nevers; 🇫🇷 Nevers, France

CH Cannes; 🇫🇷 Cannes, France

CH Chartres; 🇫🇷 Chartres, France

CH Cholet; 🇫🇷 Cholet, France

CHU Clermont Ferrand; 🇫🇷 Clermont-Ferrand, France

GH de Mulhouse; 🇫🇷 Mulhouse, France

CHU Caen; 🇫🇷 Caen, France

CH Antibes; 🇫🇷 Antibes, France

Private office; 🇫🇷 Limoges, 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

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

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

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

CH Bégin; 🇫🇷 Saint-Mandé, France

CH Saint Nazaire; 🇫🇷 Saint-Nazaire, France

CHU Saint Etienne; 🇫🇷 Saint-Étienne, 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