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

Sponsor

Liga Panamericana de Asociaciones de Reumatologia (PANLAR) (Other)

Overall Status

Recruiting

CT.gov ID

NCT04821206

Collaborator

(none)

3,000

Enrollment

Locations

Anticipated Duration (Months)

1500

Patients Per Site

37.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid Arthritis, Psoriatic Spondyloarthritis	Drug: DMARDs Drug: biologic DMARDs Drug: JAK Inhibitor

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Cases Patients with diagnosis of RA, PsA and SpA	Drug: JAK Inhibitor New Initiation of a JAK Inhibitor
Controls Patients with diagnosis of RA, PsA and SpA	Drug: DMARDs New Initiation of a DMARDs Drug: biologic DMARDs New Initiation of a biologic DMARDs

Arm

Intervention/Treatment

Cases

Patients with diagnosis of RA, PsA and SpA

Drug: JAK Inhibitor

New Initiation of a JAK Inhibitor

Controls

Patients with diagnosis of RA, PsA and SpA

Drug: DMARDs

New Initiation of a DMARDs

Drug: biologic DMARDs

New Initiation of a biologic DMARDs

Outcome Measures

Primary Outcome Measures

Incidence rate of severe adverse events per each one of the drugs included. [12 months]
Incidence rate of severe adverse events per each one of the drugs included. [24 months]
Incidence rate of severe adverse events per each one of the drugs included. [36 months]

Secondary Outcome Measures

Incidence rate of all adverse events for each one of the drugs included. [12 months]
Incidence rate of all adverse events for each one of the drugs included. [24 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. [12 months]
Incidence rate of severe infections for each one of the drugs included. years. [24 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. [12 months]
Proportion of patients still on each one of the drugs included. [24 months]
Proportion of patients still on each one of the drugs included. [36 months]
Proportion of patients on remission (according to definition) for each one of the drugs included and for each one of the diseases included. [12 months]
Proportion of patients on remission (according to definition) for each one of the drugs included and for each one of the diseases included. [24 months]
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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

To be eligible for enrollment into the PREJAK Registry, a patient must satisfy all of the inclusion criteria and none of the exclusion criteria listed below.

Inclusion Criteria

The patient must be:

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