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

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ClinicalTrials.gov Identifier: NCT03131661
Recruitment Status : Active, not recruiting
First Posted : April 27, 2017
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag S.p.A.

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.

Condition or disease
Spondyloarthritis, Axial and Peripheral

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Study Type : Observational
Actual Enrollment : 351 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : June 9, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Group/Cohort
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.



Primary Outcome Measures :
  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.


Secondary Outcome Measures :
  1. Ankylosing Spondylitis Disease Activity Score (ASDAS) C-reactive Protein (CRP) [ Time Frame: Up to visit 5 (Approximately 24 month) ]
    The ASDAS is an index for measuring disease activity in participant affected by ankylosing spondylitis. The ASDAS-CRP is derived from back pain, duration of morning stiffness, general well being, C-reactive protein (CRP) and peripheral joint pain/swelling. Total score ranges from zero (reflecting no disease activity) with the upper end of the scale being determined by the level of CRP. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity (> 3.5).

  2. Bath Ankylosing Spondylitis Metrology Index (BASMI) 10 [ Time Frame: Up to visit 5 (Approximately 24 month) ]
    The BASMI is an index for measuring the mobility of the axial skeleton in participant affected by ankylosing spondylitis. 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.

  3. Disease Activity Score (DAS) 28 [ Time Frame: Up to visit 5 (Approximately 24 month) ]
    The DAS 28 is a composite score derived from the following 4 measures. The index considers four parameters to obtain the total score: Count the number of swollen joints (out of the 28); Count the number of tender joints (out of the 28); C-reactive protein (CRP) expressed in milligram per milliLitre (mg/mL); Participant's Global Assessment of disease activity.

  4. Disease Activity Index for Psoriatic Arthritis (DAPSA) [ Time Frame: Up to visit 5 (Approximately 24 month) ]
    The DAPSA is a score used to measure disease activity in participant affected by psoriatic arthritis. It comprises: 68 tender and 66 swollen joints count; Participant global assessment of health; Participant pain Visual analogue scale (VAS); C-reactive protein level (milligram per deciLiter [mg/dl]).

  5. Minimal Disease Activity (MDA) [ Time Frame: Up to visit 5 (Approximately 24 month) ]
    The MDA is a state of disease activity deemed a useful target of treatment by both the participant and physician. For a participant to achieve MDA, 5 of the following 7 criteria must be met: Tender joint count less than or equal to (<=) 1; Swollen joint count <= 1; PASI <= 1 or BSA <= 3; Participant pain VAS <= 15; Participant global activity VAS <= 20; Health Assessment Questionnaire (HAQ) <= 0.5; Tender enthesial points <= 1.

  6. Body Surface Area (BSA) [ Time Frame: Up to visit 5 (Approximately 24 month) ]
    The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand (entire palmar surface or "handprint" which equates to approximately 1 % of total body surface area. The disease severity will be classified using the following categories: mild (BSA less than [<] 3 %), moderate (BSA from 3% to 10%), and severe (BSA more than [>] 10 %).

  7. Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Up to visit 5 (Approximately 24 month) ]
    The BASFI is used to define and monitor physical functioning in participants with ankylosing spondylitis. BASFI is composed by 10 items. Score range is 0-10, with 0 (easy), reflecting no functional impairments, and 10 (impossible), reflecting maximal impairment.

  8. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Up to visit 5 (Approximately 24 month) ]
    The BASDAI is used to measure participant reported disease activity in participants with ankylosing spondylitis. A numeric response scale (0-10) with "none" and "very severe" is used to answer. The final score ranges from 0 (no disease activity) to 10 (maximal disease activity). A cut off of 4 is used to define active disease.

  9. Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: Up to visit 5 (Approximately 24 month) ]
    The HAQ-DI is used to assess the physical functioning of the participant.The participant is required to indicate the degree of difficulty they have experienced, in each 8 items of the questionnaire, in the past week, in a 4 point scale. The responses in each functional area are: 0 = able to do with no difficulty; 1 = able to do with some difficulty; 2 = able to do with much difficulty; and 3 = unable to do. The 10 individual subscale scores are averaged to give a summary score. The range of the final calculates summary score is 0-3 where lower scores are indicative of better functioning and higher score reflects worse function. HAQ-DI scores of 0 to 1 generally represent mild to moderate functional difficulty, 1 to 2 represent moderate to severe functional difficulty, and 2 to 3 indicate severe to very severe limitations of physical function or disability.

  10. Work Productivity and Activity Impairment Questionnaire (WPAI-SHP) [ Time Frame: Up to visit 5 (Approximately 24 month) ]
    The WPAI is a validated, self administered questionnaire that assesses work and activity impairment during the past 7 days. The WPAI-SHP outcomes are expressed as impairment percentages; with higher numbers indicate greater impairment and less productivity, that is, worse outcomes.


Other Outcome Measures:
  1. Number of Participants With 66/68 Swollen/Tender Joints Count [ Time Frame: Up to 5 visits (approximately 24 months) ]
    Participant's swollen and tender joints 66/68 will be evaluated at each visit.

  2. Physician Global Assessment of Participant (PhGA) Joints and Skin [ Time Frame: Up to 5 visits (approximately 24 months) ]
    The PhGA, joint and skin, will be manually filled in by physician and will be documented using a VAS scale. PhGA VAS for pain ranges from "Quite" (0 millimeter [mm]) to "Very Severe" (100 mm); VAS for joint ranges from "No Inflammation" (0 mm) to "Very Severe" (100 mm); VAS for skin ranges from "Clear" (0 mm) to "Very Severe" (100 mm).

  3. Number of Participants With Enthesitis [ Time Frame: Up to 5 visits (approximately 24 months) ]
    The Maastricht Ankylosing Spondylitis Entheses Score (MASES) is a feasible index using to investigate the enthesitis. 13 specific and sensitive sites were examined and a dichotomous 0/1 score is used to value the grading of tenderness.

  4. Number of Participants With Nail Lesions [ Time Frame: Up to 5 visits (approximately 24 months) ]
    Number of participants with count of nail lesions will be presented.

  5. Number of Participants With Dactylitis [ Time Frame: Up to 5 visits (approximately 24 months) ]
    The total number of digits of the hands and feet (that is, 0 to 20) with dactylitis will be evaluated.

  6. Number of Participants With Fibromyalgia [ Time Frame: Up to 5 visits (approximately 24 months) ]
    Fibromyalgia is evaluated by American College of Rheumatology (ACR) 2010 criteria.

  7. Number of Participants With Pain by Visual Analog Scale (VAS) [ Time Frame: Up to 5 visits (approximately 24 months) ]
    The pain VAS is a self-administered assessment used to measure the average pain during the past week. The score ranges between 0 "No pain" to 0 "The Worst Possible Pain".

  8. Number of Participants With Sleep Quality by VAS [ Time Frame: Up to 5 visits (approximately 24 months) ]
    The Sleep Quality VAS questionnaire provides a measurement of quality of sleep experienced by the participant. This subjective method attempts to measure qualitative aspects of sleep and is easily administered. The score ranges from between 0 "Very Good" to 100 "Very Bad".

  9. Participant's Global Assessment (PtGA) by VAS [ Time Frame: Up to 5 visits (approximately 24 months) ]
    The PtGA by VAS measuring the overall way the disease affects the participants at a point in time. The score will be recorded as a single vertical mark on a 100 millimeter (mm) visual analogic scale (VAS), with 0 representing the lowest level of disease activity and 100 representing the highest.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131661


Locations
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Italy
ASST Spedali Civili Brescia
Brescia, Italy, 25123
Ospedale 'Antonio Cardarelli' di Campobasso - Azienda Sanitaria Regionale del Molise
Campobasso, Italy, 86100
P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'
Catania, Italy, 95122
AO di Catanzaro 'Pugliese Ciaccio'
Catanzaro, Italy, 88100
Azienda Ospedaliera Mater Domini
Catanzaro, Italy, 88100
Ospedali Riuniti Foggia
Foggia, Italy, 71100
Ospedale La Colletta-Arenzano ASL3 Genovese
Genova, Italy, 16100
Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milano, Italy, 20122
Ospedale Luigi - Polo Universitario
Milano, Italy, 20157
Ospedale San Raffaele, IRCCS
Milan, Italy, 20132
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
Napoli, Italy, 80130
Azienda Ospedaliera Universitaria Federico II
Napoli, Italy, 80131
P.O. 'Sant'Antonio'
Padova, Italy, 35127
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, Italy, 90127
Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
Perugia, Italy, 6122
Presidio Ospedaliero Pescara
Pescara, Italy, 65100
Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale
Potenza, Italy, 85100
Policlinico Tor Vergata
Roma, Italy, 00133
Humanitas Hospital
Rozzano (MI), Italy, 20089
Operative Unit of Rheumathology, Presidio Ospedaliero Vito Fazzi - Stabilimento Osp. A. Galateo
San Cesareo Di Lecce, Italy, 73016
Ospedale Busacca - Azienda Provinciale Sanitaria di Ragusa
Scicli (Ragusa), Italy, 97018
Azienda Ospedaliera Universitaria Senese
Siena, Italy, 53100
A.O. Universitaria Ospedali Riuniti di Ancona
Torrette - Ancona, Italy, 60126
ASUI Santa Maria della Misericordia di Udine
Udine, Italy, 33100
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy, 37134
Sponsors and Collaborators
Janssen-Cilag S.p.A.
Investigators
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Study Director: Janssen-Cilag S.p.A., Italy Clinical Trial Janssen-Cilag S.p.A.

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Responsible Party: Janssen-Cilag S.p.A.
ClinicalTrials.gov Identifier: NCT03131661     History of Changes
Other Study ID Numbers: CR108297
CNTO1275PSA4006 ( Other Identifier: Janssen-Cilag S.p.A., Italy )
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Antirheumatic Agents