Clinical trial NCT03131661: A Study in Participants With a Newly Confirmed Diagnosis of Spondyloarthritis (SpA) Who Are New to Conventional, Targeted and Biological DMARDs
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondyloarthritis, Axial and Peripheral
Lead sponsor: Janssen-Cilag S.p.A.
Sponsor class: INDUSTRY
First posted: 2017-04-27
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will include outpatients with first diagnosis or confirmed diagnosis of Spondyloarthritis (SpA) and naïve to conventional, targeted or biological Disease modifying anti-rheumatic drugs (DMARDs) prescribed for SpA.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Delay
timeFrame: Baseline (Month 0)
measure: Prevalence of Axial Versus Peripheral Manifestations According to Assessment of Spondyloarthritis Classification (ASAS) Criteria
timeFrame: Up to visit 5 (Approximately 24 months)
measure: Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by ASDAS Score
timeFrame: Up to visit 5 (Approximately 24 months)
measure: Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by BASMI Score
timeFrame: Up to visit 5 (Approximately 24 months)
measure: Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by DAS28 Score
timeFrame: Up to visit 5 (Approximately 24 month)
measure: Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by Disease Activity Index for PsA (DAPSA) Score
timeFrame: Up to visit 5 (Approximately 24 months)
measure: Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by MDA
timeFrame: Up to visit 5 (Approximately 24 months)
measure: Drug Retention for cDMARDs, tDMARDs and bDMARDs
timeFrame: Up to visit 5 (Approximately 24 months)
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to visit 5 (Approximately 24 months)
Secondary outcomes:
measure: Ankylosing Spondylitis Disease Activity Score (ASDAS) C-reactive Protein (CRP)
timeFrame: Up to visit 5 (Approximately 24 month)
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI) 10
timeFrame: Up to visit 5 (Approximately 24 month)
measure: Disease Activity Score (DAS) 28
timeFrame: Up to visit 5 (Approximately 24 month)
measure: Disease Activity Index for Psoriatic Arthritis (DAPSA)
timeFrame: Up to visit 5 (Approximately 24 month)
measure: Minimal Disease Activity (MDA)
timeFrame: Up to visit 5 (Approximately 24 month)
measure: Body Surface Area (BSA)
timeFrame: Up to visit 5 (Approximately 24 month)
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Up to visit 5 (Approximately 24 month)
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Up to visit 5 (Approximately 24 month)
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI)
timeFrame: Up to visit 5 (Approximately 24 month)
measure: Work Productivity and Activity Impairment Questionnaire (WPAI-SHP)
timeFrame: Up to visit 5 (Approximately 24 month)
Other outcomes:
measure: Number of Participants With 66/68 Swollen/Tender Joints Count
timeFrame: Up to 5 visits (approximately 24 months)
measure: Physician Global Assessment of Participant (PhGA) Joints and Skin
timeFrame: Up to 5 visits (approximately 24 months)
measure: Number of Participants With Enthesitis
timeFrame: Up to 5 visits (approximately 24 months)
measure: Number of Participants With Nail Lesions
timeFrame: Up to 5 visits (approximately 24 months)
measure: Number of Participants With Dactylitis
timeFrame: Up to 5 visits (approximately 24 months)
measure: Number of Participants With Fibromyalgia
timeFrame: Up to 5 visits (approximately 24 months)
measure: Number of Participants With Pain by Visual Analog Scale (VAS)
timeFrame: Up to 5 visits (approximately 24 months)
measure: Number of Participants With Sleep Quality by VAS
timeFrame: Up to 5 visits (approximately 24 months)
measure: Participant's Global Assessment (PtGA) by VAS
timeFrame: Up to 5 visits (approximately 24 months)
Locations:
city: Brescia
country: Italy
facility: ASST Spedali Civili Brescia
city: Campobasso
country: Italy
facility: Ospedale 'Antonio Cardarelli' di Campobasso - Azienda Sanitaria Regionale del Molise
city: Catania
country: Italy
facility: P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'
city: Catanzaro
country: Italy
facility: AO di Catanzaro 'Pugliese Ciaccio'
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Mater Domini
city: Foggia
country: Italy
facility: Ospedali Riuniti Foggia
city: Genova
country: Italy
facility: Ospedale La Colletta-Arenzano ASL3 Genovese
city: Milano
country: Italy
facility: Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
city: Milan
country: Italy
facility: Ospedale San Raffaele, IRCCS
city: Napoli
country: Italy
facility: Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Padova
country: Italy
facility: P.O. 'Sant'Antonio'
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Palermo
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
city: Pescara
country: Italy
facility: Presidio Ospedaliero Pescara
city: Potenza
country: Italy
facility: Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Rozzano (MI)
country: Italy
facility: Humanitas Hospital
city: San Cesareo Di Lecce
country: Italy
facility: Operative Unit of Rheumathology, Presidio Ospedaliero Vito Fazzi - Stabilimento Osp. A. Galateo
city: Scicli (Ragusa)
country: Italy
facility: Ospedale Busacca - Azienda Provinciale Sanitaria di Ragusa
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Torrette - Ancona
country: Italy
facility: A.O. Universitaria Ospedali Riuniti di Ancona
city: Udine
country: Italy
facility: ASUI Santa Maria della Misericordia di Udine
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
Study officials:
affiliation: Janssen-Cilag S.p.A.
name: Janssen-Cilag S.p.A., Italy Clinical Trial
role: STUDY_DIRECTOR
References: