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

Sponsor

Societe Francaise de Rhumatologie (Other)

Overall Status

Recruiting

CT.gov ID

NCT04602091

Collaborator

Bordeaux PharmacoEpi (Other)

2,300

Enrollment

Locations

110.8

Anticipated Duration (Months)

38.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Inflammatory Rheumatism Psoriatic Arthritis Spondyloarthritis	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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."

Actual Study Start Date :

Oct 8, 2019

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2029

Outcome Measures

Primary Outcome Measures

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

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).
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 [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
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 [From the beginning of the study until the end of the 5 years follow-up]
Starting dosage, therapeutic adjustments, etc.
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
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
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
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)
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): 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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	CH Antibes	Antibes	France
2	Private office	Bayonne	France
3	CH Franche Comte	Belfort	France
4	CHU de Besançon	Besançon	France
5	AP-HP Avicenne	Bobigny	France
6	CHU de Bordeaux	Bordeaux	France
7	CH Bourg-en-Bresse	Bourg-en-Bresse	France
8	CHRU Brest	Brest	France
9	CHU Caen	Caen	France
10	CH Cannes	Cannes	France
11	CH Chartres	Chartres	France
12	CH Cholet	Cholet	France
13	CHU Clermont Ferrand	Clermont-Ferrand	France
14	CH Colombes	Colombes	France
15	AP-HP Henri Mondor	Créteil	France
16	CH Dax	Dax	France
17	CH de Dijon	Dijon	France
18	CH de Douai	Douai	France
19	CHD de Vendee	La Roche-sur-Yon	France
20	CH La Rochelle	La Rochelle	France
21	CHG Jacques Monod	Le Havre	France
22	AP-HP Bicetre	Le Kremlin-Bicêtre	France
23	CH Le Mans	Le Mans	France
24	CHU Lille	Lille	France
25	Private office	Limoges	France
26	CH Saint Philibert	Lomme	France
27	CHU Lyon	Lyon	France
28	Infirmerie protestante de Lyon	Lyon	France
29	CHU Marseille Sainte-Marguerite	Marseille	France
30	Hôpital Saint Joseph	Marseille	France
31	CH Mont de Marsan	Mont-de-Marsan	France
32	CHU de Montpellier	Montpellier	France
33	CH Morlaix	Morlaix	France
34	GH de Mulhouse	Mulhouse	France
35	CHU Nantes	Nantes	France
36	CH Nevers	Nevers	France
37	CHU Nice	Nice	France
38	CH Niort	Niort	France
39	CH Orleans	Orléans	France
40	AP-HP Ambroise Pare	Paris	France
41	AP-HP Bichat	Paris	France
42	AP-HP Lariboisiere	Paris	France
43	AP-HP Pitie-Salpetriere	Paris	France
44	AP-HP Saint Antoine	Paris	France
45	Hopital La Croix Saint Simon	Paris	France
46	Hôpital Cochin	Paris	France
47	CH Pau	Pau	France
48	CHU Reims	Reims	France
49	CHU Rouen	Rouen	France
50	CHU de la Reunion	Saint-Denis	France
51	CH Bégin	Saint-Mandé	France
52	CH Saint Nazaire	Saint-Nazaire	France
53	CHU Saint Etienne	Saint-Étienne	France
54	CHU Strasbourg	Strasbourg	France
55	CHU Toulouse	Toulouse	France
56	CHU Tours	Tours	France
57	CH Troyes	Troyes	France
58	CH Valence	Valence	France
59	CH Valenciennes	Valenciennes	France
60	Polyclinique Vauban	Valenciennes	France