NCT04602091

Observational Study in Patients Treated With JAK Inhibitors for Inflammatory Rheumatism (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."

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,300 (estimated)
• Sponsor: Societe Francaise de Rhumatologie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis
• Inflammatory Rheumatism
• Psoriatic Arthritis
• Spondyloarthritis

Interventions

Type	Name	Description
OTHER	no intervention	no intervention

Timeline

• Start date: 2019-10-08
• Primary completion: 2027-12-01
• Completion: 2030-06-01
• First posted: 2020-10-26
• Last updated: 2025-01-23

Locations

60 sites across 1 country: France