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The sponsor determined that enrollment would not meet their expectations and decided to withdraw the study.
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| Name | Class |
|---|---|
| Janssen Scientific Affairs, LLC | INDUSTRY |
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The goal of this research study is to better understand if there is an association between non-alcoholic fatty liver disease (NAFLD) and active psoriatic disease (PD), and to assess the effect of Guselkumab (a medication approved by the FDA instead of the standard of care to treat PD), for NAFLD patients who receive Guselkumab for their PD.
This observational research study aims to provide information on the mechanisms behind the transition from NAFLD to high-risk NASH in the PD population. Overlapping mechanisms of disease in NAFLD and PD may account for increased disease prevalence and severity, and shared drivers of disease progression offer the opportunity to ameliorate both disease entities by targeting a single pathway. This is a longitudinal study that requires two visits from individuals with psoriatic disease. Subjects must have NAFLD and at least one criterion for active psoriatic disease: i) at least 1 swollen joint or 1 site of active enthesitis; and/or (ii at least 1 psoriatic plaque to qualify for the study. The aim of the study is to determine the effect of biological therapies in liver disorders in patients with PD, in addition to the effect on joint and skin manifestations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Psoriatic Disease | Patients with active psoriatic disease (diagnosed with psoriasis and/or psoriatic arthritis) who are planning to start Guselkumab as part of their standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab Prefilled Syringe [Tremfya] | Drug | This trial aims to recruit patients who have psoriatic disease, have evidence of fatty liver disease, and have a BMI over 25, who are planning to start Guselkumab(Tremfya) as recommended by their primary rheumatologist or dermatologist |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in NAFLD severity | Improvement of NAFLD severity is defined by MRI-PDFF responders (relative decline in liver fat ≥30%) vs non-responders (relative decline in liver fat <30%) at Week 24 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in skin psoriasis severity as defined by PASI90 (Psoriasis Area and Severity Index) response | 6 months | |
| Improvement in joint arthritis as defined by an improvement of ≥ 5 of DAPSA (Disease Activity in Psoriatic Arthritis) | 6 months |
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Inclusion criteria:
Exclusion Criteria:
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A total sample of approximately 20 PD patients from UCSD rheumatology clinics. 50% of patients screened will meet the inclusion criteria for NAFLD. To provide equal representation of the Psoriatic Disease population, 10 patients who meet the inclusion criteria for moderate to severe plaque psoriasis, and approximately 10 patients who meet the inclusion criteria for active psoriatic arthritis, will be enrolled.
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D015535 | Arthritis, Psoriatic |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D025242 | Spondylarthropathies |
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| ID | Term |
|---|---|
| C000588857 | guselkumab |
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| 17 units per liter improvement in alanine aminotransferase(ALT) in those patients with elevated ALT at baseline. | Elevated ALT is defined as ≥ 30 U/L. | 6 months |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |