Clovis

Researchers are evaluating whether a modified version of metaxalone 640 mg can reduce pain in adults aged 18 to 80 years who have newly occurring low back or leg pain due to acute lumbosacral musculoskeletal conditions with spinal stenosis and sciatica. This study is a phase 4, double-blind, randomized, placebo-controlled trial designed to compare the effects of the active drug with a placebo. The goal is to understand the impact on pain levels, physical activity, and sleep interference. Participants will be randomly assigned to receive either metaxalone 640 mg capsules or inactive placebo capsules. Both treatments are taken orally every six hours for seven days alongside standard care. The study includes an initial pilot phase followed by a larger randomized phase to ensure proper evaluation with adequate participant numbers. During the study, participants will complete surveys on day 1 before starting treatment and again seven days later to report on pain amount and quality, as well as how pain affects their physical activities and sleep. Researchers will monitor changes in pain using the Numeric Pain Scale from day 1 to day 7. The total participation involves these assessments and treatment over the one-week period with attention to any safety or health changes.

Researchers are comparing treatments for people with active rheumatoid arthritis RA who have not responded well to tumor necrosis factor inhibitor TNFi biologics. This study evaluates switching to either a non-TNFi biologic drug including rituximab, abatacept, tocilizumab, or sarilumab or a targeted synthetic DMARD tsDMARD such as tofacitinib, baricitinib, or upadacitinib. The study aims to provide important real-world data on patient-reported outcomes PROs to help guide treatment decisions, as current guidelines are based on limited evidence and often influenced by insurance or physician preference. Participants will be randomized to one of two groups switching to a targeted synthetic DMARD or switching to a non-TNFi biologic drug. Both treatment options are widely used in clinical practice, but have not been directly compared in a pragmatic trial focusing on PROs. The study will allow patients to continue stable doses of conventional synthetic DMARDs like methotrexate if used for at least three months. The trial will assess changes over 12 months, focusing on functional limitation and quality of life. During the trial, participants will be monitored regularly to assess their function and symptoms using patient-reported tools such as the Health Assessment Questionnaire HAQ. Researchers will collect information on treatment effectiveness, side effects, and safety in a real-world population, including those with other health conditions. The study is designed to reflect routine clinical care and will last for at least 12 months, with follow-up to evaluate changes from baseline in physical function and other outcomes important to patients.