La Vila Joiosa

Researchers are evaluating the short-term and long-term safety and effectiveness of belimumab in adults diagnosed with early systemic lupus erythematosus (SLE) who have positive autoantibodies and continue to have active disease despite stable initial treatment. This phase 4, prospective, open-label study aims to describe how belimumab works in this specific group over a three-year period. Participants will receive belimumab (GSK1550188) administered by subcutaneous injection. There is one treatment arm where all participants will receive this drug. The study lasts for three years, during which participants will be regularly monitored to assess disease activity and treatment safety. During the study, participants will undergo various assessments including clinical evaluations to measure disease activity, laboratory tests, and questionnaires to track health status. The main outcome is the percentage of participants who achieve Lupus Low Disease Activity State (LLDAS) by week 52. Safety and efficacy will be closely monitored throughout the study period, with follow-up visits and evaluations scheduled at regular intervals.

Researchers are evaluating the use of long-acting Cabotegravir (CAB) and Rilpivirine (RPV) in adults aged 60 years and older who are living with HIV-1 and have controlled viral levels. This study aims to confirm that the effectiveness and safety of CAB LA + RPV LA in older adults are comparable to those in younger patients. Additionally, the study monitors metabolic and liver health markers, as older adults may have more related health issues. Psychological and social well-being is also considered due to the potential impact of social stigma on this group. Participants receive an initial induction treatment with intramuscular injections of CAB LA 600 mg and RPV LA 900 mg at months 1 and 2. Following this, they receive the same injections every two months for a total duration of 24 months. This long-acting injectable treatment replaces their stable oral antiretroviral therapy regimen. Throughout the study, researchers assess viral load to confirm that HIV remains controlled with plasma HIV-1 RNA levels below 50 copies/mL. Participants are regularly monitored for metabolic and hepatic parameters, and adherence to treatment is tracked. The study also evaluates psychosocial aspects and overall safety during the two-year period to better understand treatment outcomes in this older population.

Researchers are conducting an observational study called SOGUG-PRINCIS to collect and analyze data on the effectiveness of drugs recently approved for treating genitourinary tumors under routine clinical practice in Spain. This national, multicenter study includes both retrospective patient data and prospective follow-up, aiming to validate real-world outcomes compared to those reported in phase III clinical trials. The study covers cancers originating in the kidney, ureter, bladder, prostate, testicle, urethra, penis, and seminal vesicles. The study observes patients treated with drugs such as darolutamide combined with androgen deprivation therapy and docetaxel, adjuvant nivolumab after surgical removal of urothelial carcinoma, and enfortumab vedotin. All treatments follow their approved dosing and administration guidelines in standard clinical practice. New subprojects may be added as new drugs gain funding approval by the Spanish National Health System, with each subproject focusing on specific primary endpoints. Participants' involvement includes treatment decisions made independently from the study, with data collected afterward to assess outcomes. Researchers will track progression-free survival at 18 months, relapse-free survival at 24 months, and overall survival at 12 months after treatment initiation. The study also serves as a registry for genitourinary cancer treatments funded nationally, supporting long-term evaluation of drug effectiveness in real-world settings.