La Vila Joiosa

Researchers are evaluating the short-term and long-term effects and safety of belimumab in adults with early systemic lupus erythematosus SLE who have positive autoantibodies and ongoing disease activity despite stable first-line treatment. This is a prospective, open-label, single-arm Phase 4 clinical study sponsored by GlaxoSmithKline. The study focuses on adults diagnosed within two years with active SLE, aiming to better understand how belimumab works in this group. Participants will receive belimumab GSK1550188 administered subcutaneously throughout the study. The treatment and observation period lasts for three years, with key evaluations at one year and longer-term follow-ups up to three years. There is no placebo or comparison group, as all participants receive the study drug. During the study, participants will have regular visits to assess disease activity, including the Lupus Low Disease Activity State LLDAS at week 52 and other measures such as the SLE Responder Index 4 SRI4, flare frequency, and improvements in skin symptoms. Researchers will monitor safety by tracking adverse events and serious adverse events. Blood tests, questionnaires, and physical assessments will be done to evaluate fatigue, damage, and disease remission. Participants will be followed for up to 156 weeks to assess long-term outcomes and safety.

Researchers are evaluating the effectiveness and safety of long-acting Cabotegravir plus Rilpivirine treatment in people living with HIV-1 who are aged 60 years or older. This study aims to compare the treatment results in this older population to those seen in younger patients. It also explores possible improvements in metabolic and liver health, as well as considers psychosocial factors such as stigma and psychological disorders that may affect older patients living with HIV. Participants will receive Cabotegravir 600 mg and Rilpivirine 900 mg injections into the muscle every two months after an initial induction phase with doses at months 1 and 2. The study focuses on patients who are stable on oral antiretroviral therapy ART and evaluates the switch to the long-acting injectable regimen over a 24-month period. During the study, participants will be regularly monitored for viral load levels, immune response, and any confirmed virologic failures. The research team will also track safety events related to the treatment. The primary outcome measured is the number of patients maintaining plasma HIV-1 RNA levels at or below 50 copiesmL after switching treatments at 12 months, with additional assessments conducted at 6, 12, and 24 months to monitor ongoing viral control and safety.

Researchers are conducting a national, multicenter observational study called SOGUG-PRINCIS to collect and analyze data on patients with genitourinary cancers treated with recently approved drugs under routine clinical practice in Spain. This study is both retrospective and prospective, aiming to validate real-world effectiveness of these drugs and support future funding decisions. It will serve as a registry where new subprojects will open whenever new drugs receive authorization. The study follows patients who have started treatment with specific drugs funded by the Spanish National Health System, including darolutamide combined with androgen deprivation therapy and docetaxel for hormone-sensitive prostate cancer, adjuvant nivolumab after surgery for urothelial carcinoma, and enfortumab vedotin for urothelial carcinoma. All treatments follow their approved dosing and administration guidelines and standard clinical practice. Participants progress will be monitored through routine data collection to evaluate outcomes such as progression-free survival at 18 months, relapse-free survival at 24 months, and overall survival at 12 months after starting treatment. Data will be gathered from patients treated at participating centers, with follow-up continuing as per routine care. The study does not intervene in treatment decisions, which are made independently before enrollment.