Arakawa City

This research aims to evaluate the long-term safety and effectiveness of the drug baricitinib in treating juvenile idiopathic arthritis JIA in children and adolescents aged 1 to under 18 years. Participants in this study have previously taken part in other baricitinib studies for JIA. The purpose is to monitor how well baricitinib works and to assess any serious side effects over an extended period. Participants will receive baricitinib orally during the study. This is a single-group trial where all participants receive the same treatment. The study follows participants for a total duration of up to 264 weeks approximately 5 years, during which they will be monitored closely for safety and disease activity. Throughout the study, participants will have regular assessments including monitoring for serious adverse events and treatment discontinuations. Researchers will also evaluate disease activity, pain levels, and other health measures using various clinical tools at baseline and at the end of the study period. This long-term follow-up ensures thorough evaluation of baricitinibs impact and participant well-being.

Researchers are evaluating the safety and effectiveness of brenipatide alongside standard care compared to a placebo plus standard care in adult participants with major depressive disorder. This study aims to see if brenipatide can delay the return of major depressive symptoms. It is a Phase 3, randomized, double-blind trial sponsored by Eli Lilly and Company. Participants receive brenipatide or placebo through subcutaneous injections combined with their regular treatment. The study includes three periods a screening period lasting about 1 month, a treatment period of at least 12 months, and a follow-up period of about 2 months. The study duration may be shortened if depressive symptoms worsen or if participants withdraw. During the trial, participants will attend regular visits where various assessments will be conducted, including depression rating scales, functional impairment scores, and quality of life questionnaires. Researchers will monitor body weight changes, anxiety levels, and blood samples to measure drug levels and immune responses. The primary outcome is the time until relapse of major depressive disorder symptoms. Safety and adherence to self-injection and study procedures will be closely followed throughout participation.

Researchers are evaluating the effects of nipocalimab on children aged 2 to less than 18 years with generalized myasthenia gravis gMG, a condition causing muscle weakness. The study aims to assess the safety, tolerability, and how the body processes nipocalimab in pediatric participants who have not responded well to stable standard treatments. This open-label, multicenter trial is sponsored by Janssen Research & Development, LLC and focuses on both pharmacokinetics and pharmacodynamics over an extended period. Participants are divided into two age groups children aged 2 to less than 12 years and adolescents aged 12 to less than 18 years, with US sites only including those 8 to less than 18 years old. All will receive nipocalimab through an intravenous infusion every two weeks for 24 weeks. After this treatment period, participants may choose to join a long-term extension phase to continue monitoring. Throughout the study, participants will undergo regular evaluations including blood tests to measure total serum immunoglobulin G IgG levels and monitor for adverse events, laboratory abnormalities, vital signs, and physical examinations. Additional assessments include measuring drug concentration and immune response markers. The study also tracks changes in myasthenia gravis symptoms and quality of life over a period of up to three years, with ongoing safety and pharmacokinetic monitoring during this time.

This research aims to evaluate how well and safely orforglipron works in adult female participants with stress urinary incontinence SUI who also have obesity or are overweight. SUI is a condition where urine leaks during activities such as coughing or exercising. The study is a Phase 3 clinical trial conducted under a master protocol supporting two independent studies, focusing on this specific population. Participants will be randomly assigned to receive either orforglipron or a placebo, both given orally once daily. The study uses a double-blind design with parallel groups to compare the effects of orforglipron against placebo. The treatment period lasts approximately 52 weeks, followed by safety follow-up, making total participation about 58 weeks from screening to study completion. During the study, participants will undergo assessments including measuring changes in the frequency of incontinence episodes, body weight, quality of life related to urinary incontinence, use of continence pads, and cholesterol levels. Researchers will monitor waist circumference and patient impressions of their condition as well. Safety follow-up continues after treatment to ensure participant well-being throughout the study duration.

Researchers are evaluating the safety and effectiveness of nipocalimab compared to a placebo in adults with chronic inflammatory demyelinating polyneuropathy CIDP who initially respond to nipocalimab. The study includes both Phase 2 and Phase 3 stages and aims to delay relapse in patients with CIDP who have shown clinical improvement from the treatment. Participants first receive an open-label loading dose of nipocalimab by intravenous infusion on Day 1, followed by infusions every two weeks from Week 2 to Week 12 Stage A. Those who respond and show clinical improvement move to Stage B, where they are randomly assigned to receive either nipocalimab or placebo infusions every two weeks for up to 52 weeks. After Stage B or if relapse occurs, participants may join an open-label extension phase receiving nipocalimab infusions every two weeks for up to two years or until commercial availability. During the study, participants undergo regular assessments including clinical evaluations, muscle strength tests, disability scales, and monitoring for adverse events. Researchers track time to relapse, changes in disability scores, muscle strength, grip strength, and laboratory values over the study periods. Safety is closely monitored through vital signs, laboratory tests, and adverse event reporting. The total participation can extend through the treatment phases and the long-term open-label extension as applicable.

Researchers are evaluating the overall survival of patients with stage I epithelial ovarian cancer after they have undergone comprehensive staging surgery. This phase III trial compares the outcomes of adjuvant chemotherapy versus observation alone. The study aims to determine whether adding chemotherapy after surgery improves survival in this patient group. Participants will be randomly assigned to one of two groups. One group receives adjuvant chemotherapy, which includes either a combination of paclitaxel and carboplatin or docetaxel and carboplatin, given every three weeks for three to six cycles. Switching between paclitaxel and docetaxel is allowed if adverse events occur. The other group undergoes observation without chemotherapy. During the study, participants will be monitored for overall survival up to 60 months from randomization. Researchers will also assess relapse-free survival within the same timeframe. Evaluations include follow-ups to track disease progression, side effects, and general health. The study ensures participants receive appropriate care and measures outcomes to better understand treatment benefits and risks.