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It is an observational, single-center, prospective, exploratory, open-label study to assess the efficacy and safety of IL-17 inhibitors on subclinical enthesitis in patients with moderate to severe psoriasis with subclinical enthesitis based on Power Doppler (PD) Ultrasonography (PDUS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| moderate to severe psoriasis with subclinical enthesitis based on PDUS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IL-17i | Drug | IL-17 inhibitors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Glasgow Ultrasound Enthesitis Scoring System (GUESS) from baseline to week 24 | Glasgow Ultrasound Enthesitis Scoring System (GUESS) is an ultrasonographic score of lower limb enthesitis including superior pole of the patella-quadriceps tendon enthesis, inferior pole of the patella-proximal patellar ligament enthesis, tibial tuberosity-distal patellar ligament enthesis, superior pole of the calcaneus-achilles tendon enthesis and inferior pole of the calcaneus-plantar aponeurosis enthesis, composed of assessments of degenerative changes such as tendon thickness, existence of enthesitis, bursitis, or erosions. It is calculated as follows: one point was scored for each abnormality at each site examined, giving a possible maximum total score for both lower extremities 36. A higher score of GUESS represents more serve inflammation and involvement of enthesis while a lower score represents better outcomes. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Glasgow Ultrasound Enthesitis Scoring System(GUESS) from baseline to week 4, 12, 36, 52 | Glasgow Ultrasound Enthesitis Scoring System (GUESS) is an ultrasonographic score of lower limb enthesitis including superior pole of the patella-quadriceps tendon enthesis, inferior pole of the patella-proximal patellar ligament enthesis, tibial tuberosity-distal patellar ligament enthesis, superior pole of the calcaneus-achilles tendon enthesis and inferior pole of the calcaneus-plantar aponeurosis enthesis, composed of assessments of degenerative changes such as tendon thickness, existence of enthesitis, bursitis, or erosions. It is calculated as follows: one point was scored for each abnormality at each site examined, giving a possible maximum total score for both lower extremities 36. A higher score of GUESS represents more serve inflammation and involvement of enthesis while a lower score represents better outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Risk factors at baseline contributing to PsA development | Risk factors at baseline contributing to PsA development (psoriasis phenotype, severity, comorbidities, genetic predisposition, obesity) | Week 52 |
| Association of risk factors with the development of PsA |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients with moderate to severe plaque psoriasis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjun Hou, Dr | Contact | + 86 135 8402 3320 | hwjnanjing@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35513599 | Result | Schett G, Rahman P, Ritchlin C, McInnes IB, Elewaut D, Scher JU. Psoriatic arthritis from a mechanistic perspective. Nat Rev Rheumatol. 2022 Jun;18(6):311-325. doi: 10.1038/s41584-022-00776-6. Epub 2022 May 5. | |
| 39055795 | Result | Chen R, Zhong X, Huang D, Chen Z, Yu Y, Lu J, Wang Q, Kong L, Yi X, Zhao Y, Ding Y, Guo L, Shi Y. Advantages of ultrasound imaging for the early diagnosis of psoriatic arthritis in patients with moderate to severe psoriasis. Heliyon. 2024 Jul 4;10(13):e34136. doi: 10.1016/j.heliyon.2024.e34136. eCollection 2024 Jul 15. |
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| Week 4, 12, 36, 52 |
| Complete resolution of enthesitis from baseline to week 24 | Complete resolution of enthesitis from baseline to week 24 based on enthesis assessed by GUESS. It means the percentage reaching a score of 0 for each enthesis. Higher percentage represents higher improvement. | Week 24 |
| Complete resolution of enthesitis from baseline to week 52 | Complete resolution of enthesitis from baseline to week 52 based on enthesis assessed by GUESS. It means the percentage reaching a score of 0 for each enthesis. Higher percentage represents higher improvement. | Week 52 |
| New bone erosion, bursitis, osteophytes at week 24 | New bone erosion, bursitis, osteophytes at week 24 based on enthesis assessed by GUESS. It means the percentage that the score changes from 0 to 1 in the item of 'erosion, bursitis, osteophytes' for each enthesis. Higher percentage represents more worsening of inflammation. | Week 24 |
| New bone erosion, bursitis, osteophytes at week 52 | New bone erosion, bursitis, osteophytes at week 52 based on enthesis assessed by GUESS. It means the percentage that the score changes from 0 to 1 in the item of 'erosion, bursitis, osteophytes' for each enthesis. Higher percentage represents more worsening of inflammation. | Week 52 |
| Change of patient pain assessment based on Visual Analog Scale (VAS) at week 4, 12, 24, 36, 52 | Change of patient pain assessment based on Visual Analog Scale (VAS) at week 4, 12, 24, 36, 52. The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors. For pain intensity, the scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 100 [100-mm scale]). Higher score represents more severe pain. | Week 4, 12, 24, 36, 52 |
| Change of PASI from baseline to week 24, 52 | The Psoriasis Area and Severity Index Score (PASI) is a physician assessment that combines the assessment of the severity (erythema, induration and desquamation) of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease). The higher the score the more severe the psoriasis. | Week 24, 52 |
| Change of BSA% from baseline to week 24, 52 | Body Surface Area (BSA) is a measure of how much skin is impacted by psoriasis and can be used to track an individual's psoriasis over time. For context, one handprint is equal to approximately 1 percent BSA. Involvement of <3% BSA is considered mild, 3%-10% BSA is considered moderate and >10% of BSA is considered severe psoriasis. | Week 24, 52 |
| Change of mNAPSI from baseline to week 24, 52 | The mNAPSI is a tool for physicians to evaluate the severity of nail bed psoriasis and nail matrix psoriasis by area of involvement in the nail unit. Each fingernail is rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement). The total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement). The higher the score the more severe the nail bed psoriasis. | Week 24, 52 |
| Change of PSSI from baseline to week 24, 52 | The Psoriasis Scalp Severity Index scale (PSSI) rates psoriasis severity on the scalp based on three parameters: erythema (redness), scaling, and thickness. Each parameter is assessed individually, and the scores are combined to provide an overall severity rating. The total PSSI score is a sum of scores for erythema, induration, and desquamation x involved area, ranges 0 (no disease) to 72 (maximal disease). The higher the score the more severe the scalp psoriasis is. | Week 24, 52 |
| Change of HAQ-DI from baseline to week 24, 52 | The HAQ-DI is scored on a four-level difficulty scale ranging from zero (normal, no difficulty) to three (unable to do, extreme difficulty). There are 20 questions covering eight domains: dressing, rising, eating, talking, hygiene, reach, grip, and usual activities. The highest score for an item within each domain is taken as the score for that domain; the HAQ-DI total score is the average of the eight domain scores and therefore ranges between 0 and 3. Scores of 0-1 represent mild to moderate difficulty; 1-2 represent moderate to severe disability; 2-3 represent severe to very severe disability. | Week 24, 52 |
| Change of SJC66 and TJC68 from baseline to week 24, 52 | 66/68 swollen and tender joint counts (SJC66/TJC68) | Week 24, 52 |
| Change of SPARCC enthesitis index from baseline to week 24, 52 | Medial epicondyle (left/right (L/R)) Lateral epicondyle (L/R) Supraspinatus insertion into greater tuberosity of humerus (L/R) Greater trochanter (L/R) Quadriceps insertion into superior border of patella (L/R) Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R) Achilles tendon insertion into calcaneum (L/R) Plantar fascia insertion into calcaneum (L/R) | Week 24, 52 |
| Proportion of patients who progressed to PsA at Week 52 | Proportion of patients who progressed to PsA at Week 52, based on CASPAR | Week 52 |
Association of risk factors with the development of PsA at 52 weeks |
| Week 52 |
| Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | Nanjing | Jiangsu | 210008 | China |
|
| 18259687 | Result | Weiner SM, Jurenz S, Uhl M, Lange-Nolde A, Warnatz K, Peter HH, Walker UA. Ultrasonography in the assessment of peripheral joint involvement in psoriatic arthritis : a comparison with radiography, MRI and scintigraphy. Clin Rheumatol. 2008 Aug;27(8):983-9. doi: 10.1007/s10067-008-0835-y. Epub 2008 Feb 8. |
| 12228161 | Result | Balint PV, Kane D, Wilson H, McInnes IB, Sturrock RD. Ultrasonography of entheseal insertions in the lower limb in spondyloarthropathy. Ann Rheum Dis. 2002 Oct;61(10):905-10. doi: 10.1136/ard.61.10.905. |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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