Other Clinical Trial - A Study in Participants With a Newly Confirmed

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

Spondyloarthritis, Axial and Peripheral Clinical Trial

Official title:
A Prospective, Observational Study, in Patients With a Newly Confirmed Diagnosis of Spondyloarthritis (SpA) According to ASAS Criteria, naïve to Conventional (cDMARDs), Targeted (tsDMARDs) and Biological DMARDs (bDMARDs) - SIRENA Study (Spondyloarthritis Italian Registry: Evidence From a National Pathway)

Clinical Trial Summary

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.

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT03131661
Study type	Observational
Source	Janssen-Cilag S.p.A.
Contact
Status	Completed
Phase
Start date	June 9, 2017
Completion date	July 28, 2021

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms