Schaumburg

Researchers are evaluating the effects of two different methods of giving pegloticase, a drug for uncontrolled gout, combined with methotrexate (MTX). This Phase 3 trial compares pegloticase given as an 18 mg injection under the skin every two weeks with pegloticase given as an 8 mg intravenous (IV) infusion every two weeks, both alongside weekly oral MTX. The main goal is to see which method better maintains normalized serum uric acid levels below 6 mg/dL for at least 80% of the time during the sixth month of treatment. Participants will be randomly assigned to receive pegloticase either by subcutaneous injection or intravenous infusion every two weeks, along with weekly oral doses of methotrexate. Both groups will be treated over several months while closely monitored. The study is double-blind, meaning neither participants nor researchers know which treatment is being given to maintain unbiased results. During the trial, participants will undergo regular assessments to monitor their serum uric acid levels and overall response to treatment, especially focusing on weeks 20 through 24 (Month 6). Safety and efficacy will be tracked throughout the study, including how well participants tolerate the treatments and any side effects. The study's main measure is the proportion of participants who achieve a sustained uric acid response during Month 6.

Researchers are investigating how bone mineral density changes during long-term treatment with the relugolix combination tablet in premenopausal women aged 18 to 50 who have heavy menstrual bleeding caused by uterine fibroids or moderate to severe pain related to endometriosis. This Phase 3B, single-arm, open-label study aims to assess the safety and effects of up to 48 months (4 years) of continuous treatment, followed by a 1-year post-treatment follow-up period. Participants will receive a daily fixed-dose tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg. Bone mineral density will be monitored every 6 months using dual-energy X-ray absorptiometry during treatment. Some women who completed a prior related study may join for 3 years of treatment under this protocol. After treatment ends or if stopped early, participants will be followed for 1 year with bone density checks at 6 and 12 months. Women in the study will have regular physical, gynecological, and laboratory assessments to monitor health and treatment effects. Researchers will measure the percentage change from baseline in bone mineral density at the lumbar spine after 48 months of treatment. Safety and health status will be closely observed throughout the treatment and follow-up periods to understand the long-term impact of the relugolix combination tablet on bone health.

Psoriatic arthritis (PsA) is a long-lasting inflammatory condition that affects the joints and skin in people with psoriasis (PsO). This research aims to evaluate how well the drug zasocitinib (TAK-279) works in adults with active PsA who have not previously used biologic disease-modifying antirheumatic drugs. The study is a Phase 3 clinical trial designed to compare zasocitinib against an active comparator and placebo in this patient group. Participants will receive treatment with either zasocitinib tablets, an active comparator capsule, or a matching placebo. The study includes multiple groups to assess the effects of these treatments. Participants will be followed and treated for up to 60 weeks during the study period. During the study, participants will undergo assessments to measure the percentage achieving improvement according to the American College of Rheumatology 20 (ACR20) response at 16 weeks. Researchers will monitor symptoms, joint and skin involvement, and overall safety throughout the trial. Participants will have regular visits for evaluations and will be observed for treatment effects and any side effects over the full course of the study.

Researchers are evaluating the effectiveness of adding tirzepatide to ixekizumab therapy in adults with active psoriatic arthritis (PsA) who are overweight or obese and have at least one weight-related health issue. This Phase 4 study aims to understand how well this combination works in standard clinical practice over a period of up to 12 months. The focus is on improving physical function and achieving weight loss in this patient group. Participants will receive tirzepatide administered by subcutaneous injection after having been treated with ixekizumab for about three months. The study is open-label and single-arm, meaning all participants will get tirzepatide alongside their ongoing ixekizumab therapy. Treatment will begin within 30 days after deciding to add tirzepatide. No placebo or comparison group is mentioned. During the study, researchers will monitor participants for up to 12 months, measuring their physical functioning using the Health Assessment Questionnaire Disability Index and tracking weight loss. Safety and treatment effects will be assessed through regular evaluations. The study seeks to see how many participants achieve improved function and at least 10% weight loss by the end of the 12-month therapy period.

Researchers are evaluating a treatment approach to safely reduce oral corticosteroid (OCS) use in adults diagnosed with acetylcholine receptor positive generalized myasthenia gravis (gMG) who are already receiving intravenous ravulizumab. This phase 4, single-arm study aims to assess the effectiveness and safety of a predefined schedule for tapering OCS doses to minimize corticosteroid exposure while maintaining disease stability. Participants will follow an oral corticosteroid tapering schedule tailored to their situation, continuing with or switching to prednisone or prednisolone as part of standard care. All participants are receiving intravenous ravulizumab as their ongoing treatment. The study focuses on gradually reducing OCS dosage during the tapering period to reach a low dose or discontinue use. Throughout the study, researchers will monitor participants to see if they can reduce their daily OCS dose to 5 mg or less and maintain this for at least 4 weeks without worsening gMG symptoms. Safety and effectiveness will be assessed for up to approximately 32 weeks. Participants will undergo regular evaluations to track their response and any clinical changes during this time.

Researchers are collecting and evaluating long-term data on clinical and radiographic outcomes to better understand the safety and performance of shoulder arthroplasty over time. This study includes people with various shoulder conditions such as osteoarthritis, osteonecrosis, rotator cuff tears, rheumatoid arthritis, fractures, and infections. The trial will follow participants for at least 10 years, with no early limit on follow-up duration. The study includes patients who are either scheduled for shoulder arthroplasty or have already undergone the procedure. Participants must be skeletally mature and expected to survive at least two years beyond surgery. The study is open-label and multi-center, involving both retrospective and prospective data collection. There are no specific interventions or treatments being compared, as the focus is on observing outcomes after shoulder arthroplasty. Participants will undergo assessments including clinical and radiographic evaluations at an average of once per year throughout the study. Outcome measures include the Constant score, ASES (American Shoulder and Elbow Surgeons) score, Oxford Score (optional in the UK), TESS, and MSTS scores related to pre-operative conditions. Researchers will monitor participants for safety and implant performance during the long-term follow-up, which can last a minimum of 10 years.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the effectiveness and visual symptoms of the MiSight 1 Day contact lens in children aged 8 to 12 years with myopia. The study aims to confirm the lens's ability to slow the progression of myopia in clinical practice in the US and assess how stable the reduction in myopia remains after one year without treatment. This is a multicenter, randomized, double-masked clinical trial lasting four years, divided into two parts. In Part 1, participants are randomly assigned to wear either MiSight 1 Day lenses or Proclear 1 Day lenses for three years to compare their effects on myopia progression. In Part 2, all participants wear Proclear 1 Day lenses for one additional year to study the stability of the myopia control after stopping the MiSight lenses. Both participants and investigators remain masked to the treatment assignments from Part 1. Participants will attend scheduled visits for eye examinations including measurements of spherical equivalent refractive error and axial length. Researchers will monitor visual acuity, eye health, and myopia progression over the four-year period. The main outcomes measured are the changes in refractive error and axial length after three years and the rate of change during the one-year post-treatment period. Participants are expected to wear the lenses about 10 hours daily, six days per week, and maintain follow-up visits throughout the study.