Eagan

Researchers are evaluating the effects of icotrokinra (JNJ-77242113) compared to a placebo in people with active psoriatic arthritis (PsA), including those who have previously used biologic treatments and those who have not. The study aims to assess how well icotrokinra reduces the signs and symptoms of PsA, a condition involving joint inflammation and skin psoriasis. This is a Phase 3, randomized, double-blind, placebo-controlled trial sponsored by Janssen Research & Development, LLC. Participants will be randomly assigned to receive one of two doses of icotrokinra or a placebo. After 16 weeks, those on placebo will switch to one of the icotrokinra doses. Those who continue without discontinuing the treatment will have the option to join a long-term extension phase, continuing the same icotrokinra dose. The study involves careful monitoring of the participants’ response to the medication over time. Throughout the trial, participants will undergo assessments measuring improvements in joint swelling and tenderness, skin psoriasis severity, physical function, fatigue, and overall quality of life. These include American College of Rheumatology (ACR) responses, Psoriatic Area and Severity Index (PASI) scores, and health questionnaires. Safety and tolerance will also be closely monitored. The study is planned to last until October 2028, with regular visits and evaluations to track progress and side effects.

Researchers are evaluating the pharmacokinetics and safety of Dupilumab in children and adolescents aged 6 months to less than 18 years with prurigo nodularis, a chronic skin condition characterized by itchy nodules. This Phase 3, multicenter, open-label study aims to better understand how Dupilumab behaves in the body and its safety profile in this young population. Participants will receive Dupilumab administered by subcutaneous injection, with dosing based on their weight and age. The study includes three periods: a screening period lasting 2 to 4 weeks, a treatment period of 24 weeks during which Dupilumab is given, and a post-intervention follow-up period of 16 weeks. Each participant will have a total of 6 planned study visits over approximately 42 to 44 weeks. Throughout the study, participants will complete daily symptom diaries and undergo evaluations to measure Dupilumab concentration in the blood from Day 1 to Week 40. The study will also monitor any treatment-emergent or serious adverse events and check for the development of antibodies against Dupilumab. Safety and effectiveness assessments will continue during the follow-up period to ensure comprehensive monitoring of participant health and treatment response.

This research aims to collect safety and performance data on the PERFORM20 Humeral System, a device used for partial or total shoulder replacement in patients with conditions such as osteoarthritis, avascular necrosis, post-traumatic arthrosis of the shoulder region, and rotator cuff tear arthropathy. It is an international, single-arm, multicenter, prospective post-market clinical follow-up study designed to evaluate patient outcomes over time. The study focuses on patient-reported measures related to quality of life, pain, and function, as well as safety and radiographic assessments. Participants will undergo shoulder arthroplasty using the Tornier Perform Humeral Stem device. Data will be collected at baseline, during surgery, immediately after surgery, and then annually for up to 10 years post-operation. The study monitors the device's safety and performance through various assessments including patient satisfaction and radiological imaging throughout the follow-up period. During the study, participants will be assessed using patient-reported outcome measures such as ASES, Constant Murley, SANE, Subject Satisfaction, and EQ-5D scores from baseline through follow-up visits up to 10 years. Researchers will also track adverse events, revision surgeries, and imaging evaluations of the shoulder. The study involves long-term monitoring to understand the safety and effectiveness of the implant over time.

Researchers are evaluating treatment strategies for adults with active rheumatoid arthritis (RA) who have not responded sufficiently to tumor necrosis factor inhibitor (TNFi) biologic medications. This pragmatic trial aims to compare patient-reported outcomes (PROs) such as function, quality of life, and productivity between two groups: those switching to a non-TNFi biologic drug (rituximab, abatacept, tocilizumab, or sarilumab) and those switching to a targeted synthetic disease-modifying antirheumatic drug (tsDMARD; tofacitinib, baricitinib, upadacitinib). The study addresses a critical knowledge gap, as current treatment choices often rely on physician experience or insurance policies without robust comparative evidence. Participants will be randomly assigned to switch either to a tsDMARD or a non-TNFi biologic medication. They may continue stable doses of certain conventional synthetic DMARDs if applicable. The trial uses a real-world design to include most patients with RA, even those with other health conditions, and will compare effectiveness and side effects of the two treatment classes over time. During the 12-month study, participants will be assessed for changes in their functional limitations using standardized questionnaires sensitive to RA symptoms. Researchers will also monitor treatment toxicity and other patient-relevant outcomes to better inform future treatment decisions. This trial is sponsored by the University of Alabama at Birmingham and aims to provide practical evidence for patients, doctors, and payers.