Guselkumab
DrugGuselkumab 100 mg 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (month 0 to month 24 for arm 1; week 24 to month 24 for arm 2).
NCT Number: NCT05004727
This is a multi-center (North-America), randomized, double-blind, placebo-controlled, wait-list, interventional, preventive trial of guselkumab in high-risk psoriasis patients compared to non-biologic standard of care.
The primary objective of the proposed trial will be to test the hypothesis that a prolonged, unresolved skin inflammation coupled with musculoskeletal power-doppler ultrasound (MSKPDUS) abnormalities driven by IL-23 increase the risk for transition into PsA and that an intervention that targets one of these pivotal molecules (i.e., Guselkumab) will:
1. Diminish MSKPDUS findings at 24 weeks, and 2. Significantly reduce or prevent the emergence of synovio-enthesial phenotype at year 2.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Memorial University, St. John's, Newfoundland and Labrador, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Guselkumab 100 mg 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (month 0 to month 24 for arm 1; week 24 to month 24 for arm 2).
Time frame: Baseline, Week 24
Score is defined by the ultrasound (General Electric Logiq E9 or E10) equipment, not calculated through a scale.
Time frame: Year 2
To meet CASPAR criteria for diagnosis of PsA, a participant must have inflammatory articular disease (joint, spine, entheseal or dactyitic) and at least 3 points from the following:
Time frame: Year 1
To meet CASPAR criteria for diagnosis of PsA, a participant must have inflammatory articular disease (joint, spine, entheseal or dactyitic) and at least 3 points from the following:
Time frame: Year 2
Severity will be categorized as mild, moderate, or severe.
Time frame: Baseline, week 24
Graded from 0-3 as absent, mild, moderate or severe according to images of a reference atlas (Hammer HB 2011). PD signal: 0=no PD-signal, 1=up to three single or two confluent signals, 2=less than half of the visible intracapsular area and 3=half or more of the visible intracapsular area covered by PD-signals.
Time frame: Baseline, week 24
MASEI: Structure is considered pathological (score=1) if there is a loss of fibrillar pattern, hypoechoic aspect, or fusiform thickening of the entheses. Erosions are defined as a cortical breakage with a step-down contour defect at the attachment of entheses at bone and graded with 0=absent or 3=present. Fascia and tendon thickness are measured at the point of maximal thickness on the bony insertion and graded with 0=normal or 1=thickened according to the reference values of the MASEI index. Enthesophytes are defined as calcifications at the entheses insertions into bone and graded with 0=absent, 1=small calcification, 2=clear presence of enthesophyte/calcification, 3= large calcifications or ossifications. PD-signals within entheses are scored with 0=absent or 3=present. Bursitis is investigated at the level of distal patellar tendon (infrapatellar bursitis) and the level of Achilles tendon insertion (retrocalcaneal bursitis) and graded with 0=absent and 1=present.
Time frame: Week 24
The total BSA affected by plaque-type psoriasis will be estimated from the percentages of areas affected, including head, trunk, upper limbs and lower limbs. The following calculations will be done: each reported percentage will be multiplied by its respective body region corresponding factor (head = 0.1, trunk = 0.3, upper limbs = 0.2, lower limbs = 0.4). The resulting four percentages will be added up to estimate the total BSA affected by psoriasis.
Time frame: Week 24
Score 0 - Clear - No signs of psoriasis. Post-inflammatory hyperpigmentation may be present Score 1 - Almost clear - Normal to pink coloration of lesions; no thickening; no to minimal focal scaling Score 2 - Mild disease - Pink to light red coloration; just detectable to mild thickening; predominantly fine scaling Score 3 - Moderate disease - Dull bright red, clearly distinguishable erythema; clearly distinguishable to moderate thickening; moderate scaling Score 4 - Severe disease - Bright to deep dark red coloration; severe thickening with hard edges; severe / coarse scaling covering almost all or all lesions
Time frame: Week 24
FACIT consists of 13 statements regarding fatigue (e.g., "I feel fatigued", "I feel weak all over", "I feel tired", etc.). Items are scored as follows: 4=not at all, 3=a little bit, 2=somewhat, 1=quite a bit; 0=very much, EXCEPT items #7 and 8 which are reversed scored. Total score range is 0-52. A score of less than 30 indicates severe fatigue. The higher the score, the better the quality of life.
Time frame: Baseline, Week 24
The scale measures how good or bad one's health is on the day of the questionnaire. Total score is 0-100; the higher the score, the better the health (0 = worst health one can imagine, 100 = best health one can imagine)
Time frame: Baseline, Year 2
The scale measures how good or bad one's health is on the day of the questionnaire. Total score is 0-100; the higher the score, the better the health (0 = worst health one can imagine, 100 = best health one can imagine)
Time frame: Baseline, Week 24
IDEOM-MSK-8 is a short questionnaire that allows people with MSK conditions to report their symptoms and quality of life in a standardized way. The total range of score is 0-56; the higher the score, the better the MSK health status. In order to calculate the total score, the numbers next to the boxes that the participant has ticked on the questionnaire form is added up.
Time frame: Baseline, Week 24
Score is defined by the ultrasound (General Electric Logiq E9 or E10) equipment, not calculated through a scale.
Time frame: Up to Week 24
Assessed using ultrasound results.
Contact information is provided by the study sponsor or research team.
NYU Langone Health
Other
Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort
Acronym: PAMPA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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