Inflammatory Rheumatism, Psoriatic Arthritis, Rheumatoid Arthritis, Spondyloarthritis
Conditions
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.
Interventions
OTHERno intervention
no intervention
Sponsors
Bordeaux PharmacoEpi
Societe Francaise de Rhumatologie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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: 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 |
| 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 |
Countries
France
Outcome results
None listed