Arthritis, RheumatoidPREJAKNCT04821206
PANLAR's Latin American Registry of Rheumatic Patients Treated With Jak Inhibitors
An observational study of Arthritis, Rheumatoid and Arthritis, Psoriatic, run by Liga Panamericana de Asociaciones de Reumatologia (PANLAR) at 2 sites in Argentina.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondyloarthritis
- What is being tested?
- DMARDs, biologic DMARDs and JAK Inhibitor
- How many people
- 3,000 participants
- Where
- 2 sitesArgentina
- Study dates
- 1 Mar 2021to 1 Jul 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients who do not wish to participate or are unable to give informed consent
Trial locations and contacts
2 sites in 1 country.
Argentina2 sites, 2 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
CABA, Buenos Aires, 1199
Nicolas N Marin Zucaro, 02284681946, nicolas.marin@hospitalitaliano.org.ar
- Not yet recruiting
Nicolas Marin Zucaro
Ciudad Autonoma Buenos Aires, Buenos Aires, 1425
Nicolas M Marin Zucaro, MD, 49596200 ext. 5444, nicolasmarinzucaro@gmail.com
About this study
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).
Read the 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.
- Being tested
- DMARDs, biologic DMARDs, JAK Inhibitor
- Keywords
- Rheumatoid Arthritis, Psoriatic Arthritis, Spondyloarthritis, Janus Kinase Inhibitors
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMARDsDrug
New Initiation of a DMARDs
biologic DMARDsDrug
New Initiation of a biologic DMARDs
JAK InhibitorDrug
New Initiation of a JAK Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with diagnosis of RA, PsA and SpA Receives: Drug: JAK Inhibitor | |
| Controls | Patients with diagnosis of RA, PsA and SpA Receives: Drug: DMARDs; Drug: biologic DMARDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of severe adverse events per each one of the drugs included.
Measured: 12 months
Incidence rate of severe adverse events per each one of the drugs included.
Measured: 24 months
Incidence rate of severe adverse events per each one of the drugs included.
Measured: 36 months
Secondary outcomes (13)
Incidence rate of all adverse events for each one of the drugs included.
Measured: 12 months
Incidence rate of all adverse events for each one of the drugs included.
Measured: 24 months
Incidence rate of all adverse events for each one of the drugs included.
Measured: 36 months
Incidence rate of severe infections for each one of the drugs included. years.
Measured: 12 months
Incidence rate of severe infections for each one of the drugs included. years.
Measured: 24 months
Incidence rate of severe infections for each one of the drugs included. years.
Measured: 36 months
Proportion of patients still on each one of the drugs included.
Measured: 12 months
Proportion of patients still on each one of the drugs included.
Measured: 24 months
Proportion of patients still on each one of the drugs included.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Liga Panamericana de Asociaciones de Reumatologia (PANLAR)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Marin Zucaro, Liga Panamericana de Asociaciones de Reumatologia (PANLAR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821206
- Sponsor's protocol ID
- 5858
- Acronym
- PREJAK
- Status last verified
- Mar 2021
- First submitted
- 25 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PANLAR's Latin American Registry of Rheumatic Patients Treated With Jak Inhibitors
- ClinicalTrials.gov ID
- NCT04821206
- Acronym / sponsor ID
- PREJAK / 5858
- Keywords
- Rheumatoid Arthritis, Psoriatic Arthritis, Spondyloarthritis, Janus Kinase Inhibitors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Liga Panamericana de Asociaciones de Reumatologia (PANLAR)University, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Drug: JAK InhibitorPatients with diagnosis of RA, PsA and SpA |
| Controls | – | Drug: DMARDs, Drug: biologic DMARDsPatients with diagnosis of RA, PsA and SpA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- One of the following:
- At least 18 years age or older
- Able and willing to provide written consent
Key exclusion criteria (1 listed)
- Patients who do not wish to participate or are unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMARDsNew Initiation of a DMARDs | Drug | Controls |
| biologic DMARDsNew Initiation of a biologic DMARDs | Drug | Controls |
| JAK InhibitorNew Initiation of a JAK Inhibitor | Drug | Cases |
Primary outcome
Incidence rate of severe adverse events per each one of the drugs included.
Time frame: 12 months
Incidence rate of severe adverse events per each one of the drugs included.
Time frame: 24 months
Incidence rate of severe adverse events per each one of the drugs included.
Time frame: 36 months
13 secondary outcomes
Incidence rate of all adverse events for each one of the drugs included.
Time frame: 12 months
Incidence rate of all adverse events for each one of the drugs included.
Time frame: 24 months
Incidence rate of all adverse events for each one of the drugs included.
Time frame: 36 months
Incidence rate of severe infections for each one of the drugs included. years.
Time frame: 12 months
Incidence rate of severe infections for each one of the drugs included. years.
Time frame: 24 months
Incidence rate of severe infections for each one of the drugs included. years.
Time frame: 36 months
Proportion of patients still on each one of the drugs included.
Time frame: 12 months
Proportion of patients still on each one of the drugs included.
Time frame: 24 months
Proportion of patients still on each one of the drugs included.
Time frame: 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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid and Arthritis, Psoriatic, run by Liga Panamericana de Asociaciones de Reumatologia (PANLAR) at 2 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas M Marin Zucaro (59496200 ext. 5444, nicolas.marin@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of severe adverse events per each one of the drugs included. (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.