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

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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)

ClinicalTrials.gov ID

NCT03131661

Acronym / sponsor ID

SIRENA / CR108297

Conditions

Spondyloarthritis, Axial and Peripheral

Study type

Observational

Recruitment status

Completed

Enrolment

351 participants (actual)

Lead sponsor

Janssen-Cilag S.p.A.Industry (pharma, biotech, devices)

Study start

9 Jun 2017 (actual)

Primary completion

28 Jul 2021 (actual)

Study completion

28 Jul 2021 (actual)

First posted

27 Apr 2017 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Diagnostic Delay

   Time frame: Baseline (Month 0)

   Time of diagnostic delay, defined as the time in months from first symptoms to diagnosis, and reasons for this delay.

2. Prevalence of Axial Versus Peripheral Manifestations According to Assessment of Spondyloarthritis Classification (ASAS) Criteria

   Time frame: Up to visit 5 (Approximately 24 months)

   The ASAS criteria distinguish axial from peripheral SpA. ASAS criteria for axial SpA: chronic back pain (>=3 months) with onset at age <45 years, and include imaging and clinical arm. Imaging criteria: must have sacroiliitis visible on either pelvic radiograph (representing the Ankylosing Spondylitis subgroup) or active inflammation detected by Magnetic Resonance Imagining (MRI) of the sacroiliac joints, and at least one other feature of SpA. Clinical criteria: should be Human Leukocyte Antigen (HLA) B27 positive and have at least two other SpA associated features. ASAS criteria for peripheral manifestations: must have arthritis, dactylitis or enthesitis in combination with either at least one of psoriasis, inflammatory bowel disease, uveitis, preceding genitourinary or gastro intestinal infection, HLA B27 positivity or sacroiliitis, or with two or more of arthritis, dactylitis, enthesitis, inflammatory back pain (at any time in the participant's history) or a family history of SpA.

3. Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by ASDAS Score

   Time frame: Up to visit 5 (Approximately 24 months)

   The ASDAS is composite score based on the calculation of 5 disease activities: 4 are participant's reported outcomes (back pain, duration of morning stiffness, participant global and peripheral pain/swelling) and one serologic inflammation marker (C-reactive protein [CRP]). The score is the sum of the 5 items with different specified weights, with a minimum of 0 and no upper limit. Thus this index can reflect both long term disease activity and acute phase status. There are 2 cut-offs in score to show: a) the 4 states of disease activity: inactive disease (less than [<] 1.3), moderate disease activity (1.3-2.1), high disease activity (2.1-3.5) and very high disease activity (greater than [>] 3.5). b) effectiveness of the treatment, two validated cut-offs were developed: a change of 1.1-2.0 (clinically important improvement) and a change >2.0 (major improvement).

4. Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by BASMI Score

   Time frame: Up to visit 5 (Approximately 24 months)

   The Bath Ankylosing Spondylitis Metrology Index (BASMI) is an index for measuring the mobility of the axial skeleton in participant affected by ankylosing spondylitis (AS). This index consists of 5 clinical measurements, including lumber side flexion, tragus to wall distance, lumbar flexion, intermalleoar distance and cervical rotation. Individual scores are averaged to give a final score between 0 and 10. A higher BASMI10 score reflects more severe spinal mobility limitation.

5. Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by DAS28 Score

   Time frame: Up to visit 5 (Approximately 24 month)

   The Disease Activity and functional status assessment (DAS) 28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: 0 = no disease activity to 100 = maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. European League Against Rheumatism (EULAR) Good response: DAS28 less than or equal to (<=) 3.2 or a change from Baseline less than (<) -1.2. EULAR Moderate response: DAS28 greater than (>) 3.2 to <= 5.1 or a change from Baseline < -0.6 to greater than or equal to (>=) -1.2.

6. Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by Disease Activity Index for PsA (DAPSA) Score

   Time frame: Up to visit 5 (Approximately 24 months)

   The DAPSA score will be calculated by the data collection tool and is the sum of the following: Participant's assessment of pain on visual analog scale (VAS) (in centimeters), Participant's Global Assessment of Disease Activity on VAS, 66 and 68 joint counts for swelling and tenderness, respectively. Joints assessed include the distal interphalangeal (DIP), proximal interphalangeal (PIP), and metacarpophalangeal (MCP) joints of the hands; the wrist, elbow, shoulder, acromioclavicular, sternoclavicular, temporomandibular, hip (excluded for swelling), knee, ankle, and midtarsal joints; and the metatarsophalangeal and PIP joints of the feet. CRP level in milligrams per deciliters (mg/dL). Cutoff values for low and high disease activity are <= 18.5 and >= 45.1 points, 25 respectively, and for remission is <= 3.3 points.

7. Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by MDA

   Time frame: Up to visit 5 (Approximately 24 months)

   Minimal Disease Activity (MDA) is a state of disease activity deemed a useful target of treatment by both the participant and physician. The goal of the development of this instrument is to "treat to target" to achieve disease remission or low disease activity state. For a participant to achieve MDA, 5 of the following 7 criteria must be met: Tender joint count =<1; Swollen joint count =<1; Psoriasis Area and Severity Index (PASI) =<1 or Body surface area (BSA) =<3; Participant pain VAS =<15; Participant global activity VAS =<20; HAQ =<0.5; Tender enthesial points =<1.

8. Drug Retention for cDMARDs, tDMARDs and bDMARDs

   Time frame: Up to visit 5 (Approximately 24 months)

   Drug Retention is defined as the time in months in which participants maintain the same therapy.

9. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

   Time frame: Up to visit 5 (Approximately 24 months)

   An adverse event is any untoward medical occurrence in a clinical study that does not necessarily have a causal relationship with the investigational drug under study.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
• Derived from this study: PubMed 40715761Favalli EG, Luchetti Gentiloni MM, Selmi C, Ramonda R, Grembiale RD, Dagna L, D'Angelo S, Gerli R, Foti R, Ciccia F, Guggino G, Franceschini F, Chimenti MS, Rossini M, Lubrano E, Frediani B, Marelli S, Zabotti A. The Impact of Sex on the Pattern and Clinical Response of Early Psoriatic Arthritis: Real-life Data from the Italian Prospective SIRENA Study. Rheumatol Ther. 2025 Oct;12(5):941-960. doi: 10.1007/s40744-025-00787-1. Epub 2025 Jul 25.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

25 sites in 1 country: see every site and its status.