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."

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Spondyloarthritis; Inflammatory Rheumatism
• Intervention / Treatment: Other: no intervention

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 Type: Observational
• Enrollment (Estimated): 2300

Contacts and Locations

Study Locations

• France
  • Antibes, France
    • Ch Antibes
  • Bayonne, France
    • Private Office
  • Belfort, France
    • CH Franche Comte
  • Besançon, France
    • CHU de Besançon
  • Bobigny, France
    • Ap-Hp Avicenne
  • Bordeaux, France
    • CHU de Bordeaux
  • Bourg-en-Bresse, France
    • CH Bourg-en-Bresse
  • Brest, France
    • CHRU BREST
  • Caen, France
    • CHU CAEN
  • Cannes, France
    • Ch Cannes
  • Chartres, France
    • CH Chartres
  • Cholet, France
    • CH Cholet
  • Clermont-Ferrand, France
    • CHU clermont ferrand
  • Colombes, France
    • CH Colombes
  • Créteil, France
    • AP-HP Henri Mondor
  • Dax, France
    • CH Dax
  • Dijon, France
    • CH de Dijon
  • Douai, France
    • CH de DOUAI
  • La Roche-sur-Yon, France
    • CHD de Vendée
  • La Rochelle, France
    • CH La Rochelle
  • Le Havre, France
    • CHG Jacques Monod
  • Le Kremlin-Bicêtre, France
    • AP-HP Bicêtre
  • Le Mans, France
    • CH Le Mans
  • Lille, France
    • CHU Lille
  • Limoges, France
    • Private Office
  • Lomme, France
    • CH Saint Philibert
  • Lyon, France
    • CHU Lyon
  • Lyon, France
    • Infirmerie Protestante de Lyon
  • Marseille, France
    • Hopital Saint Joseph
  • Marseille, France
    • CHU Marseille Sainte-Marguerite
  • Mont-de-Marsan, France
    • CH Mont de Marsan
  • Montpellier, France
    • CHU de Montpellier
  • Morlaix, France
    • CH Morlaix
  • Mulhouse, France
    • GH de Mulhouse
  • Nantes, France
    • CHU Nantes
  • Nevers, France
    • CH Nevers
  • Nice, France
    • CHU Nice
  • Niort, France
    • CH Niort
  • Orléans, France
    • Ch Orleans
  • Paris, France
    • Hopital Cochin
  • Paris, France
    • AP-HP Bichat
  • Paris, France
    • AP-HP Ambroise Paré
  • Paris, France
    • AP-HP Lariboisière
  • Paris, France
    • Ap-Hp Pitie-Salpetriere
  • Paris, France
    • AP-HP Saint Antoine
  • Paris, France
    • Hopital La Croix Saint Simon
  • Pau, France
    • CH Pau
  • Reims, France
    • CHU Reims
  • Rouen, France
    • CHU Rouen
  • Saint-Denis, France
    • Chu de La Reunion
  • Saint-Mandé, France
    • CH Bégin
  • Saint-Nazaire, France
    • CH Saint Nazaire
  • Saint-Étienne, France
    • CHU Saint Etienne
  • Strasbourg, France
    • CHU Strasbourg
  • Toulouse, France
    • CHU Toulouse
  • Tours, France
    • CHU Tours
  • Troyes, France
    • CH Troyes
  • Valence, France
    • CH VALENCE
  • Valenciennes, France
    • CH Valenciennes
  • Valenciennes, France
    • Polyclinique Vauban

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

French patients treated for chronic inflammatory rheumatic disorders according to EMA.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
Drug interactions	Identify new drug interactions	From the beginning of the study until the end of the 5 years follow-up
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
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
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
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

Collaborators and Investigators

• Sponsor: Societe Francaise de Rhumatologie
• Collaborators: Bordeaux PharmacoEpi
• Investigators: Principal Investigator: Marie-Elise TRUCHETET, CHU de Bordeaux - Pellegrin; Principal Investigator: Jerôme AVOUAC, AP-HP Hôpital Cochin; Principal Investigator: Clément PRATI, CHRU De Besancon

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Connective Tissue Diseases; Infections; Bone Diseases, Infectious; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Psoriasis; Streptococcal Infections; Arthritis; Spondylitis; Spondylarthritis; Arthritis, Psoriatic; Rheumatic Diseases; Collagen Diseases; Rheumatic Fever
• Other Study ID Numbers: MAJIK Registry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No