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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Patients with diagnosis of RA, PsA and SpA |
| |
| Controls | Patients with diagnosis of RA, PsA and SpA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMARDs | Drug | New Initiation of a DMARDs |
| |
| biologic DMARDs |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of severe adverse events per each one of the drugs included. | 12 months | |
| Incidence rate of severe adverse events per each one of the drugs included. | 24 months | |
| Incidence rate of severe adverse events per each one of the drugs included. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of all adverse events for each one of the drugs included. | 12 months | |
| Incidence rate of all adverse events for each one of the drugs included. | 24 months | |
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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:
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
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas M Marin Zucaro | Contact | 59496200 | 5444 | nicolas.marin@hospitalitaliano.org.ar |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Italiano de Buenos Aires | Recruiting | CABA | Buenos Aires | 1199 | Argentina |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| D025241 | Spondylarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D018501 | Antirheumatic Agents |
| D000075242 | Janus Kinase Inhibitors |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D047428 | Protein Kinase Inhibitors |
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| Drug |
New Initiation of a biologic DMARDs |
|
| JAK Inhibitor | Drug | New Initiation of a JAK Inhibitor |
|
| Incidence rate of all adverse events for each one of the drugs included. |
| 36 months |
| Incidence rate of severe infections for each one of the drugs included. years. | 12 months |
| Incidence rate of severe infections for each one of the drugs included. years. | 24 months |
| Incidence rate of severe infections for each one of the drugs included. years. | 36 months |
| Proportion of patients still on each one of the drugs included. | 12 months |
| Proportion of patients still on each one of the drugs included. | 24 months |
| Proportion of patients still on each one of the drugs included. | 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. | 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. | 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. | 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. | Baseline |
| Nicolas Marin Zucaro | Not yet recruiting | Ciudad Autonoma Buenos Aires | Buenos Aires | 1425 | Argentina |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |