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

• Conditions: Spondyloarthritis; Arthritis, Psoriatic; Arthritis, Rheumatoid
• Interventions: Drug: JAK Inhibitor; Drug: DMARDs; Drug: biologic DMARDs

• Registration Number: NCT04821206
• Lead Sponsor: Liga Panamericana de Asociaciones de Reumatologia (PANLAR)

Brief 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.

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-01
• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-26
• Last Update Submitted: 2021-03-26
• Study First Posted: 2021-03-29
• Last Update Posted: 2021-03-29
• Primary Completion: 2024-02-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	JAK Inhibitor	Patients with diagnosis of RA, PsA and SpA
Controls	DMARDs	Patients with diagnosis of RA, PsA and SpA
Controls	biologic DMARDs	Patients with diagnosis of RA, PsA and SpA

Primary Outcome Measures

Name	Time	Method
Incidence rate of severe adverse events per each one of the drugs included.	36 months

Secondary Outcome Measures

Name	Time	Method
Proportion of patients on remission (according to definition) for each one of the drugs included and for each one of the diseases included.	36 months
Incidence rate of all adverse events for each one of the drugs included.	36 months
Incidence rate of severe infections for each one of the drugs included. years.	36 months
Proportion of patients still on each one of the drugs included.	36 months
Proportion of patients receiving each one of the drugs included and for each one of the diseases included as first, second, third- and fourth-line therapy.	Baseline

Trial Locations

Locations (2)

Hospital Italiano de Buenos Aires; 🇦🇷 Caba, Buenos Aires, Argentina

Nicolas Marin Zucaro; 🇦🇷 Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina