- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04821206
PANLAR's Latin American Registry of Rheumatic Patients Treated With Jak Inhibitors (PREJAK)
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Nicolas M Marin Zucaro
- Phone Number: 5444 59496200
- Email: nicolas.marin@hospitalitaliano.org.ar
Study Locations
-
-
Buenos Aires
-
Caba, Buenos Aires, Argentina, 1199
- Recruiting
- Hospital Italiano de Buenos Aires
-
Contact:
- Nicolas N Marin Zucaro
- Phone Number: 02284681946
- Email: nicolas.marin@hospitalitaliano.org.ar
-
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1425
- Not yet recruiting
- Nicolas Marin Zucaro
-
Contact:
- Nicolas M Marin Zucaro, MD
- Phone Number: 5444 49596200
- Email: nicolasmarinzucaro@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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:
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
Exclusion Criteria:
Patients who do not wish to participate or are unable to give informed consent
Study Plan
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Skin Diseases, Papulosquamous
- Spinal Diseases
- Bone Diseases
- Spondylarthropathies
- Psoriasis
- Bone Diseases, Infectious
- Arthritis
- Arthritis, Rheumatoid
- Arthritis, Psoriatic
- Spondylitis
- Spondylarthritis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Kinase Inhibitors
- Antirheumatic Agents
- Janus Kinase Inhibitors
Other Study ID Numbers
- 5858
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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