El Cajon

Researchers are evaluating the efficacy, safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of PRX-115, a recombinant pegylated Uricase, in adults with gout. This phase II, multicenter, randomized, double-blind, placebo-controlled study focuses on different intravenous infusion dosing regimens of PRX-115, with and without the immunomodulator methotrexate MTX, compared to placebos. The goal is to find the best dosing schedule and assess treatment effects over 24 weeks. Participants receive PRX-115 or placebo through intravenous infusions at varying intervals every 4 weeks six doses, every 6 weeks four doses, or every 8 weeks three doses. Some groups also receive oral methotrexate 15 mg weekly or a matching placebo. The study includes multiple treatment schedules combining these dosing regimens with or without MTX, allowing comparison of different approaches. Throughout the study, participants undergo regular assessments including blood tests to monitor serum uric acid levels, safety labs, and evaluations for adverse events. The primary outcome measures the percentage of patients achieving serum uric acid below 6 mgdL after 6 months of treatment. Safety and tolerability are closely monitored from enrollment until 8 months. The total participation length includes infusion visits and follow-up evaluations to gather comprehensive data on treatment impact and safety.

Researchers are evaluating the safety and effectiveness of IMVT-1402 in adults with moderate to severe primary Sjogrens disease, a condition characterized by systemic symptoms. This Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study aims to compare IMVT-1402 to a placebo by measuring changes in disease activity at 24 weeks. Participants will receive weekly subcutaneous injections of either IMVT-1402 at one of two doses or a placebo. The study includes a treatment phase with dosing and monitoring, followed by ongoing participation lasting up to 105 weeks total for each individual. Throughout the study, participants will undergo regular assessments including clinical disease activity scoring using the Clinical European League Against Rheumatism Sjogrens Syndrome Disease Activity Index clinESSDAI. Additional evaluations include physician assessments of disease activity and antibody testing. Safety and tolerability will be closely monitored during the entire study duration.

Researchers are evaluating the effectiveness and safety of CARTISTEM, a combination of stem cells derived from human umbilical cord blood and a sodium hyaluronate gel, compared to a surgical procedure called debridement in people with knee cartilage lesions and osteoarthritis. The trial aims to show whether CARTISTEM can better reduce knee pain and improve knee function than debridement two years after treatment. It also explores if CARTISTEM might slow down the progression of osteoarthritis by using MRI scans. Participants are randomly assigned to one of two groups one group receives CARTISTEM along with debridement surgery on the affected knee, while the other group undergoes debridement surgery alone. CARTISTEM includes stem cells suspended in a gel that is applied during the procedure. The study follows participants for 24 months after treatment to assess results and safety. During the study, participants will have their knee pain and function measured using standard scales like the Visual Analog Scale VAS and WOMAC function score. MRI scans will be used to observe cartilage repair and osteoarthritis changes. Participants will be monitored regularly throughout the two-year follow-up period to track outcomes and any side effects. This trial lasts from enrollment through 24 months post-treatment, providing comprehensive evaluations over time.

Researchers are evaluating a diabetes education program tailored for Arab Americans with type 2 diabetes. This program, called Project Dulce Arabic, addresses cultural and language barriers that affect diabetes management in this community. It combines peer-led group education in Arabic and a 3-month text messaging support program. The study also explores the genetic background of type 2 diabetes in Arab Americans to increase awareness and improve prevention strategies. The intervention includes a 5-week peer-led curriculum covering diabetes knowledge, diet, exercise, medication, self-monitoring, and genetics. Afterward, participants receive ongoing support through Dulce Digital, a text messaging platform providing reminders and educational messages in Arabic. This combination aims to improve diabetes self-management behaviors and clinical outcomes such as hemoglobin A1C over three and six months. Participants will join the education sessions and receive text messages while researchers assess changes in diabetes knowledge, health beliefs, self-efficacy, and genetics understanding at 3 and 6 months. They will also track physical activity, diet, self-care activities, and hemoglobin A1C levels. The study involves blood tests and questionnaires to measure progress and gather genetic samples for research. The total participation includes ongoing monitoring throughout the study period ending in 2026.