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

NCT03131661 | Completed

• 2 other identifiers: CR108297CNTO1275PSA4006
• Study Type: observational
• Target: 351
• Locations: 1 country
• Sites: 25

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.

Conditions

Spondyloarthritis, Axial and Peripheral

Outcome Measures

Primary Outcomes (9)

• Diagnostic Delay

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

  Baseline (Month 0)

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

  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.

  Up to visit 5 (Approximately 24 months)

• Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by ASDAS Score

  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).

  Up to visit 5 (Approximately 24 months)

• Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by BASMI Score

  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.

  Up to visit 5 (Approximately 24 months)

• Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by DAS28 Score

  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.

  Up to visit 5 (Approximately 24 month)

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

  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.

  Up to visit 5 (Approximately 24 months)

• Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by MDA

  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.

  Up to visit 5 (Approximately 24 months)

• Drug Retention for cDMARDs, tDMARDs and bDMARDs

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

  Up to visit 5 (Approximately 24 months)

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

  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.

  Up to visit 5 (Approximately 24 months)

Secondary Outcomes (10)

• Ankylosing Spondylitis Disease Activity Score (ASDAS) C-reactive Protein (CRP)

  Up to visit 5 (Approximately 24 month)

• Bath Ankylosing Spondylitis Metrology Index (BASMI) 10

  Up to visit 5 (Approximately 24 month)

• Disease Activity Score (DAS) 28

  Up to visit 5 (Approximately 24 month)

• Disease Activity Index for Psoriatic Arthritis (DAPSA)

  Up to visit 5 (Approximately 24 month)

• Minimal Disease Activity (MDA)

  Up to visit 5 (Approximately 24 month)

Other Outcomes (9)

• Number of Participants With 66/68 Swollen/Tender Joints Count

  Up to 5 visits (approximately 24 months)

• Physician Global Assessment of Participant (PhGA) Joints and Skin

  Up to 5 visits (approximately 24 months)

• Number of Participants With Enthesitis

  Up to 5 visits (approximately 24 months)

Study Arms (1)

SpA with DMARDs

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag S.p.A.: lead

Study Sites (25)

ASST Spedali Civili Brescia

Brescia, 25123, Italy

Location

Ospedale 'Antonio Cardarelli' di Campobasso - Azienda Sanitaria Regionale del Molise

Campobasso, 86100, Italy

Location

P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'

Catania, 95122, Italy

Location

AO di Catanzaro 'Pugliese Ciaccio'

Catanzaro, 88100, Italy

Location

Azienda Ospedaliera Mater Domini

Catanzaro, 88100, Italy

Location

Ospedali Riuniti Foggia

Foggia, 71100, Italy

Location

Ospedale La Colletta-Arenzano ASL3 Genovese

Genova, 16100, Italy

Location

Ospedale San Raffaele, IRCCS

Milan, 20132, Italy

Location

Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

Milan, 20122, Italy

Location

Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli

Napoli, 80130, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Napoli, 80131, Italy

Location

P.O. 'Sant'Antonio'

Padua, 35127, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, 90127, Italy

Location

Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia

Perugia, 6122, Italy

Location

Presidio Ospedaliero Pescara

Pescara, 65100, Italy

Location

Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale

Potenza, 85100, Italy

Location

Policlinico Tor Vergata

Roma, 00133, Italy

Location

Humanitas Hospital

Rozzano (MI), 20089, Italy

Location

Operative Unit of Rheumathology, Presidio Ospedaliero Vito Fazzi - Stabilimento Osp. A. Galateo

San Cesareo Di Lecce, 73016, Italy

Location

Ospedale Busacca - Azienda Provinciale Sanitaria di Ragusa

Scicli (Ragusa), 97018, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

A.O. Universitaria Ospedali Riuniti di Ancona

Torrette - Ancona, 60126, Italy

Location

ASUI Santa Maria della Misericordia di Udine

Udine, 33100, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37134, Italy

Location

Related Publications (1)

• Favalli 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.

  PMID: 40715761 DERIVED

MeSH Terms

Conditions

Spondylarthritis

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Officials

• Janssen-Cilag S.p.A., Italy Clinical Trial

  Janssen-Cilag S.p.A.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 27, 2017
• Study Start: June 9, 2017
• Primary Completion: July 28, 2021
• Study Completion: July 28, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

IT (25)