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

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ClinicalTrials.gov Identifier: NCT04821206
Recruitment Status : Recruiting
First Posted : March 29, 2021
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Nicolas Marin Zucaro, 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).

Condition or disease Intervention/treatment
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: PANLAR's Latin American Registry of Rheumatic Patients Treated With Jak Inhibitors
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Incidence rate of severe adverse events per each one of the drugs included. [ Time Frame: 12 months ]
  2. Incidence rate of severe adverse events per each one of the drugs included. [ Time Frame: 24 months ]
  3. Incidence rate of severe adverse events per each one of the drugs included. [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Incidence rate of all adverse events for each one of the drugs included. [ Time Frame: 12 months ]
  2. Incidence rate of all adverse events for each one of the drugs included. [ Time Frame: 24 months ]
  3. Incidence rate of all adverse events for each one of the drugs included. [ Time Frame: 36 months ]
  4. Incidence rate of severe infections for each one of the drugs included. years. [ Time Frame: 12 months ]
  5. Incidence rate of severe infections for each one of the drugs included. years. [ Time Frame: 24 months ]
  6. Incidence rate of severe infections for each one of the drugs included. years. [ Time Frame: 36 months ]
  7. Proportion of patients still on each one of the drugs included. [ Time Frame: 12 months ]
  8. Proportion of patients still on each one of the drugs included. [ Time Frame: 24 months ]
  9. Proportion of patients still on each one of the drugs included. [ Time Frame: 36 months ]
  10. 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 ]
  11. 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 ]
  12. 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 ]
  13. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04821206


Contacts
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Contact: Nicolas M Marin Zucaro 59496200 ext 5444 nicolas.marin@hospitalitaliano.org.ar

Locations
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Argentina
Hospital Italiano de Buenos Aires Recruiting
Caba, Buenos Aires, Argentina, 1199
Contact: Nicolas N Marin Zucaro    02284681946    nicolas.marin@hospitalitaliano.org.ar   
Nicolas Marin Zucaro Not yet recruiting
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1425
Contact: Nicolas M Marin Zucaro, MD    49596200 ext 5444    nicolasmarinzucaro@gmail.com   
Sponsors and Collaborators
Liga Panamericana de Asociaciones de Reumatologia (PANLAR)
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Responsible Party: Nicolas Marin Zucaro, MD, Liga Panamericana de Asociaciones de Reumatologia (PANLAR)
ClinicalTrials.gov Identifier: NCT04821206    
Other Study ID Numbers: 5858
First Posted: March 29, 2021    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Nicolas Marin Zucaro, Liga Panamericana de Asociaciones de Reumatologia (PANLAR):
Rheumatoid Arthritis
Psoriatic Arthritis
Spondyloarthritis
Janus Kinase Inhibitors
Additional relevant MeSH terms:
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Arthritis
Spondylarthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Spondylitis
Spinal Diseases
Bone Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthropathies
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antirheumatic Agents
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action