Clovis

Researchers are evaluating if a modified form of metaxalone 640 mg can reduce pain in adults aged 18 to 80 years who experience new low back or leg pain due to acute lumbosacral musculoskeletal conditions, including spinal stenosis and sciatica. This is a double-blind, randomized, placebo-controlled Phase 4 study comparing the active drug to a look-alike placebo. The purpose is to measure changes in pain and how it affects physical activity and sleep over one week. Participants will be randomly assigned to receive either metaxalone 640 mg oral tablets along with standard care or a placebo that looks the same but contains no active drug. The study consists of an initial pilot phase followed by a larger phase with more participants to confirm results. Treatments are taken as oral tablets, and participants continue their usual care. During the study, participants will complete surveys on Day 1 before starting treatment and again on Day 7 to report pain levels, pain quality, and how pain affects their physical activity and sleep. Researchers will monitor changes in pain using a Numeric Pain Scale from Day 1 to Day 7. Participants must be able to respond to text or email reminders for surveys. The total study duration for each participant is 7 days of treatment and follow-up.

Researchers are evaluating treatment strategies for people with active rheumatoid arthritis (RA) who have not improved despite using tumor necrosis factor inhibitor (TNFi) biologic drugs. The study compares switching to a non-TNFi biologic drug (such as rituximab, abatacept, tocilizumab, or sarilumab) versus switching to a targeted synthetic disease-modifying antirheumatic drug (tsDMARD) like tofacitinib, baricitinib, or upadacitinib. This comparative effectiveness research addresses a critical gap in evidence, as current treatment choices are often based on physician experience or insurance preferences rather than strong data. The study uses patient-reported outcomes (PROs) to provide meaningful information for patient-centered care. Participants will be assigned to receive either a non-TNFi biologic or a tsDMARD as their new treatment for active RA after TNFi biologic therapy. The study allows participants to continue certain conventional synthetic DMARDs (such as methotrexate, sulfasalazine, hydroxychloroquine, or leflunomide) if they have been stable on these for a specified period. Treatment choice is supported by insurance or patient assistance programs to ensure access. This pragmatic trial is designed to reflect real-world practice and includes patients with comorbidities to assess effectiveness and safety in a broad population. During the study, participants will be monitored for changes in functional ability over 12 months using the Health Assessment Questionnaire (HAQ), a sensitive measure for RA impact. Researchers will also evaluate quality of life, productivity, and side effects. The study aims to generate evidence that helps patients and payers make informed decisions about RA treatments based on outcomes that matter most to patients. Total participation includes baseline assessments and follow-up evaluations throughout the 12-month treatment period.