Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
NCT06641089
Arthritis, Arthritis, Psoriatic
Avondale, Arizona, United States
View Trial DetailsNCT Number: NCT07220824
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Policlinico di Bari, Bari, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline and 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Weeks 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.
Time frame: 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.
Time frame: Up to Week 52
Number of participants who were persistent with guselkumab treatment up to 52 weeks after initiation will be reported.
Time frame: Up to Week 52
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.
Contact information is provided by the study sponsor or research team.
Janssen Research & Development, LLC
Industry
GUselkumab for the Treatment of PsA: Effectiveness Results by Ultrasound
Acronym: GURU
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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