Observational Study in Patients Treated With JAK Inhibitors for Inflammatory Rheumatism (MAJIK)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Inflammatory Rheumatism
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 in...
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.
Tracking Information
- NCT #
- NCT04602091
- 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 Besançon