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

March 26, 2021 updated by: Nicolas Marin Zucaro, Liga Panamericana de Asociaciones de Reumatologia (PANLAR)
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).

Study Overview

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 Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Buenos Aires
      • Caba, Buenos Aires, Argentina, 1199
      • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1425
        • Not yet recruiting
        • Nicolas Marin Zucaro
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The registry will be a cohort study where cases will be patients with RA, PsA and AS initiating any approved JAK inhibitor. To have an active control group, patients with RA or PsA initiating any other disease modifying antirheumatic drug (DMARD) (biologic or not biologic) will also be included in the registry.

Description

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:

  1. One of the following:

    1. Diagnosis with rheumatoid arthritis (RA) and initiating (prescribed or starting) a Januse Kinase inhibitors (JAKi) for the treatment of RA at the enrollment visit.
    2. 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.
    3. Diagnosis with psoriatic arthritis (PsA) and initiating (prescribed or starting) a Januse Kinase inhibitors (JAKi) for the treatment of PsA at the enrollment visit.
  2. At least 18 years age or older
  3. Able and willing to provide written consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of severe adverse events per each one of the drugs included.
Time Frame: 12 months
12 months
Incidence rate of severe adverse events per each one of the drugs included.
Time Frame: 24 months
24 months
Incidence rate of severe adverse events per each one of the drugs included.
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of all adverse events for each one of the drugs included.
Time Frame: 12 months
12 months
Incidence rate of all adverse events for each one of the drugs included.
Time Frame: 24 months
24 months
Incidence rate of all adverse events for each one of the drugs included.
Time Frame: 36 months
36 months
Incidence rate of severe infections for each one of the drugs included. years.
Time Frame: 12 months
12 months
Incidence rate of severe infections for each one of the drugs included. years.
Time Frame: 24 months
24 months
Incidence rate of severe infections for each one of the drugs included. years.
Time Frame: 36 months
36 months
Proportion of patients still on each one of the drugs included.
Time Frame: 12 months
12 months
Proportion of patients still on each one of the drugs included.
Time Frame: 24 months
24 months
Proportion of patients still on each one of the drugs included.
Time Frame: 36 months
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.
Time Frame: 12 months
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.
Time Frame: 24 months
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.
Time Frame: 36 months
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.
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

March 25, 2021

First Submitted That Met QC Criteria

March 26, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 29, 2021

Last Update Submitted That Met QC Criteria

March 26, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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