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

Last updated: March 26, 2021
Sponsor: Liga Panamericana de Asociaciones de Reumatologia (PANLAR)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Joint Injuries

Rheumatoid Arthritis

Psoriatic Arthritis

Treatment

N/A

Clinical Study ID

NCT04821206
5858
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

To be eligible for enrollment into the PREJAK Registry, a patient must satisfy all of theinclusion criteria and none of the exclusion criteria listed below. Inclusion Criteria The patient must be:

  1. One of the following:
  2. Diagnosis with rheumatoid arthritis (RA) and initiating (prescribed or starting)a Januse Kinase inhibitors (JAKi) for the treatment of RA at the enrollmentvisit.
  3. Meet the ASAS criteria for axial spondyloarthritis (AxSpA), includingradiographic or non-radiographic, and initiating (prescribe or starting) a JAKifor the treatment of AxSpA at the enrollment visit.
  4. Diagnosis with psoriatic arthritis (PsA) and initiating (prescribed or starting)a Januse Kinase inhibitors (JAKi) for the treatment of PsA at the enrollmentvisit.
  5. At least 18 years age or older
  6. Able and willing to provide written consent

Exclusion

Exclusion Criteria: Patients who do not wish to participate or are unable to give informed consent

Study Design

Total Participants: 3000
Study Start date:
March 01, 2021
Estimated Completion Date:
July 01, 2024

Study 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.

Connect with a study center

  • Hospital Italiano de Buenos Aires

    Caba, Buenos Aires 1199
    Argentina

    Active - Recruiting

  • Nicolas Marin Zucaro

    Ciudad Autonoma Buenos Aires, Buenos Aires 1425
    Argentina

    Site Not Available

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