NCT04821206

PANLAR's Latin American Registry of Rheumatic Patients Treated With Jak Inhibitors

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Liga Panamericana de Asociaciones de Reumatologia (PANLAR) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, non-interventional, research registry is designed to study the comparative safety and comparative effectiveness of approved Jak Inhibitors treatment for RA-PsA-SpA in a cohort of patients and theirs controls cared for by rheumatologists across Latin América (LA).

Detailed description

There is scarce data on the real-world safety and effectiveness of Jak in Latin America. This registry will provide reliable data on the use of JAKi in LA, as will be a prospective study involving carefully selected rheumatologists and centers. Soon, a good number of copies of original JAKi will be available in LA, and it is important to keep track of the safety and effectiveness of this drugs in the real world. The primary objective of the registry is to prospectively study the comparative safety and comparative effectiveness of approved Jak Inhibitors treatment for RA-PsA-SpA in a cohort of patients and theirs controls cared for by rheumatologists across Latin América (LA). The registry will be a cohort study where cases will be patients with RA, PsA and SpA initiating any approved JAK inhibitor. To have an active control group, patients with RA, PsA o SpA initiating any other disease modifying antirheumatic drug (DMARD) (biologic or not biologic) will also be included in the registry. It will be a Web based registry, where the investigators will include data related to the cases and controls. Data collected will include, demographics, disease characteristics, disease activity, past and current medications, comorbidities. At each visit adherence with the medications, adverse events, changes in medications, disease activity and disability will be assessed.Patients will be followed up at three months intervals, after inclusion in the registry and thereafter every 6 months during the next three years. Adverse events could be included at any time between visits if the investigator is notified.

Conditions

• Arthritis, Rheumatoid
• Arthritis, Psoriatic
• Spondyloarthritis

Interventions

Type	Name	Description
DRUG	DMARDs	New Initiation of a DMARDs
DRUG	biologic DMARDs	New Initiation of a biologic DMARDs
DRUG	JAK Inhibitor	New Initiation of a JAK Inhibitor

Timeline

• Start date: 2021-03-01
• Primary completion: 2024-02-01
• Completion: 2024-07-01
• First posted: 2021-03-29
• Last updated: 2021-03-29

Locations

2 sites across 1 country: Argentina

Regulatory

• FDA-regulated drug study