NCT04821206

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

2.9 years

First QC Date

March 25, 2021

Last Update Submit

March 26, 2021

Conditions

Arthritis, PsoriaticArthritis, RheumatoidSpondyloarthritis

Keywords

Rheumatoid ArthritisPsoriatic ArthritisSpondyloarthritisJanus Kinase Inhibitors

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (13)

  • 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

  • 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

  • +8 more secondary outcomes

Study Arms (2)

Cases

Patients with diagnosis of RA, PsA and SpA

Drug: JAK Inhibitor

Controls

Patients with diagnosis of RA, PsA and SpA

Drug: DMARDsDrug: biologic DMARDs

Interventions

DMARDsDRUG

New Initiation of a DMARDs

Controls
biologic DMARDsDRUG

New Initiation of a biologic DMARDs

Controls
JAK InhibitorDRUG

New Initiation of a JAK Inhibitor

Cases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • 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
  • Patients who do not wish to participate or are unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Italiano de Buenos Aires

CABA, Buenos Aires, 1199, Argentina

RECRUITING

Nicolas Marin Zucaro

Ciudad Autonoma Buenos Aires, Buenos Aires, 1425, Argentina

NOT YET RECRUITING

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis, PsoriaticSpondylarthritis

Interventions

Antirheumatic AgentsJanus Kinase Inhibitors

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylarthropathiesSpondylitisSpinal DiseasesBone DiseasesPsoriasisSkin Diseases, PapulosquamousSkin Diseases

Intervention Hierarchy (Ancestors)

Therapeutic UsesPharmacologic ActionsChemical Actions and UsesProtein Kinase InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological Action

Central Study Contacts

Nicolas M Marin Zucaro

CONTACT

59496200nicolas.marin@hospitalitaliano.org.ar

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 29, 2021

Study Start

March 1, 2021

Primary Completion

February 1, 2024

Study Completion

July 1, 2024

Last Updated

March 29, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

AR(2)