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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Rheumatoid Arthritis, Inflammatory Rheumatism, Psoriatic Arthritis, Spondyloarthritis

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|no intervention|

What is the study measuring?
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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 |