Temecula

Researchers are evaluating the short-term and long-term safety and effectiveness of belimumab in adults diagnosed with early systemic lupus erythematosus (SLE) who have positive autoantibodies and continue to have active disease despite stable initial treatment. This phase 4, prospective, open-label study aims to describe how belimumab works in this specific group over a three-year period. Participants will receive belimumab (GSK1550188) administered by subcutaneous injection. There is one treatment arm where all participants will receive this drug. The study lasts for three years, during which participants will be regularly monitored to assess disease activity and treatment safety. During the study, participants will undergo various assessments including clinical evaluations to measure disease activity, laboratory tests, and questionnaires to track health status. The main outcome is the percentage of participants who achieve Lupus Low Disease Activity State (LLDAS) by week 52. Safety and efficacy will be closely monitored throughout the study period, with follow-up visits and evaluations scheduled at regular intervals.

Major depressive disorder (MDD) is a common and serious mood disorder causing persistent sadness and loss of interest, along with emotional and physical symptoms like irritability, tiredness, and changes in appetite. This trial investigates the effects of oral Icalcaprant, an experimental drug, on adults currently experiencing a major depressive episode. The study aims to assess changes in disease activity and monitor adverse events over the treatment period. Participants will be randomly assigned to one of three groups, with about one-third receiving a placebo. Those in the treatment arms will take oral capsules of Icalcaprant once daily for six weeks. After the treatment period, there will be a 30-day safety follow-up to monitor any ongoing effects or side effects. During the study, participants will visit the hospital or clinic regularly for medical assessments, blood tests, side effect monitoring, and to complete questionnaires. Researchers will evaluate changes in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) and track the number of participants experiencing adverse events. The total participation duration includes the six-week treatment and the 30-day follow-up.

Researchers are studying sleep patterns in adults with Major Depressive Disorder (MDD) who experience moderate to severe insomnia symptoms (MDDIS) or no to mild insomnia symptoms (non-MDDIS). The goal is to evaluate brain activity during sleep using an at-home sleep Electroencephalogram (EEG) device and to understand how these objective sleep measurements relate to participants' own sleep experiences. Participants will use a sleep EEG device at home to record brain activity during sleep over a specified period. Alongside this, subjective sleep data will be collected using various self-report tools including sleep diaries and standardized questionnaires like the Structured Interview Guide for the Hamilton Depression Rating Scale and Patient-Reported Outcomes Measurement Information System forms. During the study, participants will be assessed both objectively through the EEG recordings and subjectively through questionnaires and interviews about their sleep quality and disturbances. The researchers will analyze these data to characterize sleep features in participants with different levels of insomnia symptoms, monitoring safety and compliance throughout the study period.

Researchers are evaluating the treatment outcomes of subcutaneous anifrolumab 120 mg once weekly as add-on therapy to antimalarials, with or without glucocorticoids (GCs), in patients with systemic lupus erythematosus (SLE) who have not previously used immunosuppressants or biologics. The study focuses on patients not in Lupus Low Disease Activity State (LLDAS) at enrollment and aims to describe clinical outcomes such as achieving DORIS remission, while also understanding GC tapering and withdrawal possibilities. This is a Phase 3, open-label, single-arm study. Approximately 275 participants aged 18 to 70 will receive anifrolumab subcutaneously once weekly for 52 weeks following a screening period of up to 35 days. Participants may increase their GC dose until week 4 based on investigator recommendation, then those on more than 5 mg/day GC at entry will attempt a taper to 5 mg/day over 12 weeks between weeks 5 and 40. Participants achieving DORIS remission for two visits will then attempt complete GC withdrawal with a 12-week taper. After week 41 until study end, no further GC dose reductions will occur. Following treatment, a 12-week safety follow-up is included for those not continuing anifrolumab. Participants will undergo assessments including clinical evaluations, laboratory tests, and questionnaires to monitor disease activity, remission status, and safety. Researchers will measure attainment of DORIS remission at week 52 as the primary outcome. Study evaluations will include ANA and other antibody testing, infection screening, HPV testing, and adherence to study procedures. The total study duration is approximately 69 weeks, including screening, treatment, and follow-up periods.

Researchers are evaluating the effects of JNJ-89495120, an investigational drug, on reducing symptoms of major depressive disorder (MDD) in adults. This Phase 2 study compares JNJ-89495120 to a placebo to assess its antidepressant effects, safety, and tolerability in participants diagnosed with recurrent MDD without psychotic features. Participants must be experiencing a current depressive episode that started before age 55 and lasts between 2 and 24 months. Participants will receive either JNJ-89495120 or a placebo as monotherapy during the study. The treatment is administered while maintaining a double-blind and randomized design to ensure unbiased results. Dosing details are not specified, but the study focuses on monitoring how well the drug works and how well participants tolerate it compared to placebo. During the study, researchers will monitor changes in depression symptoms using the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to Day 5. Participants will be assessed for safety and tolerability throughout the trial. The study includes adults aged 18 to 64 with specific diagnostic criteria and treatment history, aiming to provide clear evidence on the drug's impact on depression over a short treatment period.

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.

This research aims to compare two ways of giving the drug bimekizumab to adults with active psoriatic arthritis or active axial spondyloarthritis. The study focuses on whether giving bimekizumab through an intravenous (IV) injection is not worse than giving it as a subcutaneous (under the skin) injection. The trial is designed as an open-label, randomized, parallel-group, noninferiority phase 1 study to evaluate how the drug moves and stays in the body over time. Participants will receive bimekizumab at scheduled times either through one of two intravenous regimens or a subcutaneous regimen. Each group will follow a specific dosing plan to see how the drug behaves in the body depending on the method of administration. The study treatments are given at pre-set time points, and the goal is to measure drug concentrations in the blood. During the study, participants will be monitored and assessed for the drug concentration in their blood at week 16 to understand steady-state trough levels. Researchers will also check for safety and tolerability throughout the study. The total duration and further assessments are not specified, but the focus is on comparing the drug levels and safety between the different administration methods in adults with these active conditions.

Researchers are evaluating the MINI system, a non-invasive ultrasound device designed to treat adults with active, moderate to severe rheumatoid arthritis who do not respond well to or cannot tolerate standard drug treatments such as conventional synthetic, biologic, or targeted synthetic disease-modifying anti-rheumatic drugs. This study involves at least 60 participants across up to 8 sites, comparing two active ultrasound stimulation treatments against a sham control group. The device delivers ultrasound stimulation to the spleen to potentially reduce inflammation. Participants will be assigned to one of three groups: two groups receive daily 20-minute sessions of ultrasound stimulation to the spleen using different treatment settings, and one group receives a sham (inactive) stimulation for the same duration. All participants continue taking at least one conventional synthetic DMARD at a stable dose throughout the study. After 12 weeks of double-blinded treatment and assessment, those in the sham control group will switch to active stimulation for an additional 12 weeks to observe longer-term effects. Throughout the study, participants will have multiple assessments including joint evaluations to measure rheumatoid arthritis activity using the DAS28-CRP score at baseline and after 12 weeks. Researchers will monitor treatment response, medication adherence, and safety during the entire 28-week period. The study aims to compare changes in disease activity scores between the active treatment groups and the control group to assess the device's impact on rheumatoid arthritis symptoms.

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 of ALTO-300 compared to a placebo when added to an antidepressant treatment in adults with moderate to severe major depressive disorder (MDD). This Phase 2 study aims to identify differences in how well ALTO-300 works based on patient characteristics. The main goal is to measure changes in depression symptoms over six weeks using the Montgomery-Åsberg Depression Rating Scale (MADRS). Participants will receive either ALTO-300 capsules or placebo capsules once daily while continuing their current antidepressant, which must be a single SSRI, SNRI, or bupropion taken for at least six weeks without recent dose changes. The study includes a randomized, double-blind phase where neither participants nor researchers know who receives the active drug or placebo. There is also an open-label extension phase after the initial treatment period. During the study, participants will undergo regular assessments to monitor their depression symptoms and overall health. Researchers will track changes in MADRS scores up to week 6 to evaluate treatment effects. Participants must comply with all study procedures, and safety will be closely monitored throughout the trial. The study includes adults aged 18 to 70 years who meet the specific inclusion criteria and do not have any exclusion conditions.