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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959PSA4020 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess how well guselkumab works in improving symptoms of psoriatic arthritis (an inflammatory disease that affects the joints in participants with psoriasis, a skin condition that causes red, scaly patches) using muscoloskeletal ultrasound (MSUS) in a real-world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Psoriatic Arthritis | Participants with confirmed diagnosis of psoriatic arthritis treated with guselkumab as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available within routine clinical practice, including results of ultrasound examinations, will be collected in this study. Additionally, questions will be asked from participants about their health and well-being. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage Reduction From Baseline in Global OMERACT and EULAR Synovitis Score (GLOESS) at Week 12 | GLOESS is an ultrasound scoring system to assess the presence and severity of synovitis measured for 24 pairs of joints. The scoring is from 0 to 3 for each joint where 0: No abnormalities or changes, 1: Mild changes, 2: Moderate changes and 3: Severe changes. The total score for 48 joints can range from 0 to 144, where higher score indicates more inflammation. | Baseline and Week 12 |
| Percentage of Participants Achieving Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity (LDA) Score Less Than or Equal to 14, at Week 24 | Percentage of participants achieving DAPSA LDA (that is, a score less than or equal to [<=] 14) will be reported. DAPSA assesses the joint domain of PsA and is derived from the sum of the following components: Participant's assessment of pain on visual analog scale (VAS ; 0-10 centimeters [cm]; VAS 0= excellent; 10= poor), Participant's global assessment of disease activity on VAS (0 to 10 cm VAS, 0=excellent and 10=poor), tender joint count (0-68), swollen joint count (0-66) and C-reactive protein (CRP) level. A higher score indicates more active disease activity. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Resolution of Enthesitis by Ultrasound at Week 12 | Enthesitis is assessed by ultrasound using the Global Outcome Measures in Rheumatology (OMERACT) enthesitis score which scores 6 pairs of entheses bilaterally: common extensor tendon, quadriceps tendon, patellar tendon at proximal and distal insertion, achilles tendon and plantar aponeurosis. Each affected entheses out of the 6 bilateral sites will be scored according to OMERACT enthesitis composite semiquantitative scale (range 0-3) and the sum of each single abnormal site of the 6 bilateral targeted entheses is represented by Global OMERACT score ranging from 0-48. A higher score indicates more active disease activity. |
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Inclusion criteria:
Exclusion criteria:
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The study population will include participants affected with PsA according to classification for psoriatic arthritis (CASPAR) criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico di Bari | Recruiting | Bari | 70124 | Italy | ||
| ASST Spedali Civili Brescia |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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| Week 12 |
| Percentage Reduction from Baseline in Spondyloarthritis Research Consortium of Canada (SPAARC) Index at Week 24 | The SPARCC developed a measure for enthesitis in general spondyloarthritis which focuses on the clinical evaluation and validation of the following 16 entheseal sites: greater trochanter (Right/Left); quadriceps tendon insertion into the patella (Right/Left); patellar ligament insertion into the patella and tibial tuberosity (Right/Left); achilles tendon insertion (Right/Left); plantar fascia insertion (Right/Left); medial epicondyles (Right/Left); lateral epicondyles (Right/Left); supraspinatus insertion (Right/Left). Each entheseal site is assessed for tenderness on a dichotomous basis, i.e., 0= non-tender, 1= tender, for a total score ranging from 0 to 16. Higher scores indicate more severe enthesitis. Negative changes from baseline indicate improvement of enthesitis. | Baseline and Week 24 |
| Percentage of Participants Achieving DAPSA Remission at Week 24 | DAPSA assesses the joint domain of PsA where a higher score indicates more active disease activity. DAPSA remission indicates DAPSA score of 4 or less. DAPSA remission signifies a greater reduction in disease activity, with minimal or no symptoms when compared with DAPSA LDA. | Week 24 |
| Percentage of Participants Achieving DAPSA LDA/Remission at Week 52 | DAPSA assesses the joint domain of PsA where a higher score indicates more active disease activity. DAPSA remission indicates DAPSA score of 4 or less. DAPSA LDA indicates DAPSA score of 14 or less. DAPSA remission signifies a greater reduction in disease activity, with minimal or no symptoms when compared with DAPSA LDA. | Week 52 |
| Number of Participants Achieving Minimal Disease Activity (MDA) at Weeks 12, 24 and 52 | MDA status is defined by meeting 5 of 7 criteria: tender joint count <= 1; swollen joint count <=1; psoriasis area and severity index (PASI) <=1 or body surface area (BSA) with PsO <=3 percent (%); participant's VAS pain score of <=15; participant's VAS global disease activity score of <=20; disability index of the health assessment questionnaire (HAQ-DI) score <=0.5; and tender entheseal points <=1. | At Weeks 12, 24 and 52 |
| Percentage of Participants Achieving Reduction in VAS Pain Scores at Week 12 and 24 | The pain VAS is a self-administered assessment of average pain during the past week. The scale ranges from "no pain" (0 mm) to "the worst possible pain" (100 mm). Higher scores indicate more pain. | At Weeks 12, and 24 |
| Number of Participants with Improvement in Health Assessment Questionnaire Disability Index (HAQ-DI) At Weeks 12 and 24 | HAQ-DI is used to assess the long-term influence of chronic disease on a participant's level of functional ability and activity restriction. The HAQ-DI includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. For each question the score is from 0 (without any difficulty) to 3 (unable to do) where lower scores are indicative of better functioning and higher score reflects worse function. | At Weeks 12 and 24 |
| Number of Participants with Persistence to Guselkumab Treatment up to 52 Weeks | Number of participants who were persistent with guselkumab treatment up to 52 weeks after initiation will be reported. | Up to Week 52 |
| Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a participating patient administered a medicinal product. An AE does not necessarily have a causal relationship with the treatment. | Up to Week 52 |
| Recruiting |
| Brescia |
| 25123 |
| Italy |
| Hospital Carlo Urbani | Recruiting | Iesi | 60035 | Italy |
| IRCCS Ospedale Galeazzi Sant Ambrogio | Recruiting | Milan | 20157 | Italy |
| Istituto Ortopedico Gaetano Pini | Recruiting | Milan | 20122 | Italy |
| San Raffaele Hospital | Recruiting | Milan | 20132 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Recruiting | Milan | 20162 | Italy |
| Azienda Ospedaliera Universitaria Federico II | Recruiting | Naples | 80131 | Italy |
| Seconda Univesità degli Studi di Napoli, AOU | Recruiting | Naples | 80131 | Italy |
| Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone | Completed | Palermo | 90127 | Italy |
| Fondazione IRCCS Policlinico San Matteo | Recruiting | Pavia | 27100 | Italy |
| Universita degli Studi di Perugia | Recruiting | Perugia | 06123 | Italy |
| Ospedale Santa Chiara AO Universitaria Pisana | Recruiting | Pisa | 56126 | Italy |
| Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale | Recruiting | Potenza | 85100 | Italy |
| Arcispedale Santa Maria Nuova - IRCCS | Recruiting | Reggio Emilia | 42123 | Italy |
| Policlinico Di Tor Vergata | Recruiting | Roma | 00133 | Italy |
| Fondazione Policlinico Universitario A Gemelli IRCCS | Recruiting | Roma | 00136 | Italy |
| A O Universitaria Senese Ospedale Santa Maria alle Scotte | Recruiting | Siena | 53100 | Italy |
| AO Ordine Mauriziano | Recruiting | Torino | 10128 | Italy |
| ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi | Recruiting | Varese | 21100 | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona | Recruiting | Verona | 37134 | Italy |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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