A Study in Participants With a Newly Confirmed Diagnosis of Spondyloarthritis (SpA) Who Are New to Conventional, Targeted and Biological DMARDs (SIRENA)

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Spondyloarthritis, Axial and Peripheral

Study type: Observational

Funder types: Industry

Identifiers

NCT03131661

CR108297

CNTO1275PSA4006 (Other Identifier)

Details and patient eligibility

About

The purpose of this Italian multicenter study is to collect prospective clinical data in participants with first diagnosis or confirmation diagnosis of Spondyloarthritis (SpA), according to Assessment of Spondyloarthritis classification (ASAS) criteria, in order to describe SpA characteristics and pattern of clinical presentation.

Enrollment: 351 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have a first or confirmed diagnosis of Spondyloarthritis (SpA) according to Assessment of Spondyloarthritis classification (ASAS) criteria
• Participants must be naïve to conventional, targeted and biological Disease modifying anti-rheumatic drugs (DMARDs) treatment
• Participants must understand the purpose of the study
• Participants must sign a participation agreement/ Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements

Exclusion criteria

• Participants who already started conventional, targeted and biological DMARDs treatment for SpA
• Participants who participate to an investigational study in the last 30 days
• Participants unwilling or unable to participate in long-term, 24 months, data collection
• Participants unwilling or unable to fill in the Participant-reported outcome (PRO) foreseen by the protocol
• Participants unwilling or unable to sign the informed consent to the study

Trial design

351 participants in 1 patient group

SpA with DMARDs

Description:

Participants with first diagnosis or confirmed diagnosis of Spondyloarthritis (SpA) and naïve to conventional, targeted or biological Disease modifying anti-rheumatic drugs (DMARDs) will be observed in order to describe SpA characteristics and pattern of clinical presentation.