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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04821206
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Liga Panamericana de Asociaciones de Reumatologia (PANLAR)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Argentina
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondyloarthritis
Additional Details

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.

Arms & Interventions

Arms

: Cases

Patients with diagnosis of RA, PsA and SpA

: Controls

Patients with diagnosis of RA, PsA and SpA

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hospital Italiano de Buenos Aires, Caba, Buenos Aires, Argentina

Status

Recruiting

Address

Hospital Italiano de Buenos Aires

Caba, Buenos Aires, 1199

Site Contact

Nicolas N Marin Zucaro

nicolas.marin@hospitalitaliano.org.ar

02284681946

Nicolas Marin Zucaro, Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Status

Not yet recruiting

Address

Nicolas Marin Zucaro

Ciudad Autonoma Buenos Aires, Buenos Aires, 1425

Site Contact

Nicolas M Marin Zucaro, MD

nicolasmarinzucaro@gmail.com

49596200 #5444

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