Yamanashi

Researchers are evaluating treatments for people with newly diagnosed multiple myeloma who are not candidates for or do not plan to have autologous stem cell transplant as initial therapy. The study compares the effectiveness of two new combination treatments: teclistamab with daratumumab and lenalidomide (Tec-DR), and talquetamab with daratumumab and lenalidomide (Tal-DR), against the standard treatment of daratumumab, lenalidomide, and dexamethasone (DRd). This is a Phase 3 randomized study designed to assess which treatment better controls the disease. Teclistamab, talquetamab, and daratumumab are given as subcutaneous injections, while lenalidomide is taken orally. Dexamethasone can be given either orally or by intravenous injection. Participants receive one of the three treatment combinations as assigned by the study. The treatments are administered regularly over the study period, with close monitoring and follow-up to evaluate outcomes. The study includes up to 9 years of follow-up to track disease progression and survival. Participants will undergo regular assessments including monitoring for disease progression and treatment response. Key measures include progression-free survival from the time of randomization and the presence of minimal residual disease-negative complete response at 12 months. Safety and tolerability are also tracked throughout the study. Total participation time includes treatment and extended observation to assess long-term outcomes and side effects.

This research aims to evaluate the safety and effectiveness of belimumab in adults with interstitial lung disease (ILD) related to connective tissue diseases (CTDs) such as rheumatoid arthritis, lupus, and others. ILD causes lung inflammation and stiffness, reducing lung volume and leading to symptoms like shortness of breath, cough, and fatigue, significantly affecting quality of life and being a leading cause of death in these patients. The study focuses on whether adding belimumab to standard therapy can stabilize or improve lung function and relieve ILD symptoms while maintaining an acceptable safety profile. Participants will be randomly assigned to receive either belimumab or a placebo, both administered as a subcutaneous injection alongside their standard treatment. The study is a phase 3, double-blind, placebo-controlled trial designed to compare these two groups over time. Belimumab treatment is given under careful monitoring to assess its impact on lung disease progression. Throughout the study, participants will undergo assessments including lung function tests, specifically measuring forced vital capacity (FVC) at the start and after 52 weeks. Researchers will monitor changes in lung capacity to determine treatment effects. Participants will be evaluated for safety and symptom changes, with ongoing review of their ability to manage their condition. The total duration includes regular follow-ups and assessments to understand the long-term impact of the treatment.

Researchers are evaluating the effectiveness and safety of Afimkibart (RO7790121) as both an induction and maintenance treatment for people with moderately to severely active Crohn's disease in this Phase III, multicenter, double-blind, placebo-controlled study. The goal is to understand how well Afimkibart works compared to placebo in managing symptoms and disease activity over time. Participants will receive either Afimkibart or a matching placebo. Afimkibart is given both as an intravenous infusion and as a subcutaneous injection. This treat-through study means participants continue on the assigned treatment throughout the study period, allowing evaluation of both initial and ongoing therapy effects. During the study, participants will be regularly assessed to measure clinical remission using the Crohn's Disease Activity Index (CDAI) and to check for endoscopic response at week 52. Researchers will monitor safety and treatment effects throughout, with the entire participation lasting up to one year. Assessments include clinical evaluations and endoscopic examinations to track disease changes and treatment impact.

Researchers are evaluating depemokimab for adults with uncontrolled Hypereosinophilic Syndrome (HES) who are already receiving standard care treatment. This Phase 3 study is a 52-week, randomized, double-blind, placebo-controlled trial conducted at multiple centers. Participants must have a confirmed HES diagnosis, be on stable therapy for at least 4 weeks before randomization, have experienced at least two disease flares in the past year, and have a blood eosinophil count of at least 1,000 cells/µL during screening. Historical flares are defined by worsening symptoms or increased eosinophils that require treatment changes. Eligible participants will be randomly assigned in a 2:1 ratio to receive either depemokimab or a matching placebo, while continuing their usual HES therapy. The study medication will be administered alongside standard care to assess the drug’s effect on reducing HES flares over the course of one year. During the study, participants will be monitored regularly for flare frequency, safety, and treatment effects. Researchers will collect data on the number of HES flares up to 52 weeks. Safety assessments and clinical evaluations will be conducted throughout the study to understand how participants respond to the treatment and to monitor any adverse events.

Researchers are evaluating the safety and effectiveness of peficitinib in patients with rheumatoid arthritis (RA) receiving treatment in routine clinical practice. This mandatory Post-Marketing Surveillance (PMS) study is conducted as part of the Japan Risk Management Plan (J-RMP) and requested by the Pharmaceuticals and Medical Devices Agency (PMDA). The aim is to collect real-world data on patients treated with peficitinib for RA. The study involves treatment with oral peficitinib, given as part of routine clinical care. There are no comparator groups; all participants will be patients receiving peficitinib for the first time. The study focuses on monitoring safety and effectiveness in an actual clinical setting without altering the standard treatment schedule. Participants will be followed for up to 156 weeks to assess safety outcomes such as the frequency of adverse events, serious infections, malignancies, and events leading to death. Effectiveness will be measured up to 52 weeks using disease activity scores including DAS28 (using C-reactive protein and erythrocyte sedimentation rate), Simplified Disease Activity Index, Clinical Disease Activity Index, tender and swollen joint counts, and global assessments by patients and physicians. Researchers will also evaluate EULAR response criteria and remission rates. This long-term follow-up provides comprehensive safety and effectiveness data in real-world RA treatment.

This survey investigates the safety of Ondexxya Intravenous Injection 200 mg in patients who received it to neutralize the anticoagulant effect of factor Xa inhibitors during life-threatening or unarrestable bleeding episodes. The study aims to understand the occurrence of safety events known as "safety specifications," including thrombotic events, infusion reactions, and re-bleeding, as well as to detect any unknown adverse drug reactions and evaluate factors affecting safety and effectiveness under real-world use conditions. The survey collects safety and effectiveness information from all patients treated with Ondexxya for these bleeding emergencies. It does not involve comparison groups or additional interventions but focuses on monitoring the outcomes and adverse reactions associated with the drug's use in everyday clinical practice. Participants' data will be observed to measure the incidence of adverse drug reactions and safety events within 30 days after treatment. The study gathers information on patient background factors that might influence safety outcomes. There is no specified follow-up treatment or additional procedures; the total observation period for outcomes is 30 days post-treatment.

To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.