Gonesse

Researchers are evaluating the effectiveness and safety of remibrutinib in adults aged 18 to 65 years with secondary progressive multiple sclerosis (SPMS). This Phase III study is randomized, double-blind, and placebo-controlled, designed to better understand how remibrutinib affects disability progression in SPMS patients over time. Participants will be randomly assigned to receive either oral remibrutinib tablets or matching placebo tablets during the Core Part of the study, which is event-driven and double-blinded. After this period, all participants may enter an Extension Part where they receive open-label remibrutinib treatment. This design allows researchers to compare remibrutinib against placebo and then monitor long-term effects when all participants receive the active drug. Throughout the study, participants will undergo regular assessments including MRI scans and clinical evaluations to track changes in disability using the Expanded Disability Status Scale (EDSS). The primary outcome measured is the time to confirmed disability progression over six months, with follow-up lasting up to approximately five years. Safety, tolerability, and other health parameters will also be closely monitored during both study phases.

Researchers are evaluating how many patients referred to emergency departments (ED) by their general practitioners (GPs) could instead be treated in walk-in clinics. Walk-in clinics offer quick and basic medical care without appointments and can perform simple tests like blood work and X-rays. The study aims to improve patient flow and reduce overcrowding in EDs in the Île-de-France region by identifying patients who do not require full hospital emergency care. The study observes patients referred by GPs to an adult emergency service during weekdays from 9 a.m. to 8 p.m. It includes those with medical or traumatic reasons for the ED visit who are stable upon arrival and during care. No specific treatments or interventions are assigned; instead, the focus is on assessing eligibility for care in walk-in clinics versus emergency departments. Participants will be evaluated based on their referral letters, stability, treatments received, and diagnostic procedures during the ED visit. Researchers measure how many patients could have been managed in walk-in clinics within 30 minutes. The study excludes patients needing intensive hospital care or hospitalization. Data on medical stability and reason for referral are collected during the ED visit to determine appropriate care settings.

Researchers are evaluating the safety and effectiveness of the MEDTRUM Hybrid Closed Loop (HCL) System in children, adolescents, and adults aged 7 to 75 years with type 1 diabetes. The study aims to determine whether the Hybrid Closed Loop system is better at increasing the time spent in the target glucose range of 70-180 mg/dL compared to the manual Open Loop system. Participants will be trained on using the MEDTRUM A8 TouchCare Insulin Management system and randomized into either the Closed Loop or Open Loop group. They will also respond to self-administered questionnaires about hypoglycemia fear, quality of life, and treatment satisfaction. Participants will use either the MEDTRUM A8 TouchCare system in manual mode, where the Hybrid Closed Loop algorithm is not activated, or in automatic mode, where the Hybrid Closed Loop algorithm is activated. The system includes a patch pump, reservoir patches, continuous glucose monitoring with a glucose sensor and transmitter, a personal diabetes manager or app, and related software for tracking and managing glucose levels. The study will last six months, with participants using their assigned system during this time. During the study, researchers will monitor the time spent in the target glucose range during the last 12 weeks and compare results between the two groups. Participants will complete questionnaires on hypoglycemia fear, diabetes quality of life, and treatment satisfaction. Safety and effectiveness will be assessed through glucose monitoring and self-reported outcomes. The total participation duration is six months, with evaluations occurring at the end of this period.

Researchers are investigating the interactions between pregnancy and multiple sclerosis (MS), including related disorders such as neuromyelitis optica (NMO) and myelin oligodendrocyte glycoprotein (MOG)-antibody related disorders. This national prospective study aims to better understand how pregnancy impacts MS and associated conditions, focusing on questions about disease-modifying drugs (DMDs), breastfeeding, locoregional analgesia, and the short- and long-term effects on both mother and child. The study is nested within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort and includes patients across various MS-related diagnoses without age limits. Participants will not receive any experimental treatment but will be observed throughout pregnancy and up to one year after delivery. Their children will be followed until six years of age. The study collects data on pregnancy-related factors, use or discontinuation of DMDs, breastfeeding practices, and analgesia methods during delivery. Neurologists and researchers will gather information on the course of MS and related disorders before, during, and after pregnancy. During the study, participants will be monitored for treatment-related adverse events during pregnancy and the postpartum period, with assessments continuing for up to two years. Data collected will include clinical evaluations and long-term follow-up of both mothers and children. This comprehensive observation aims to provide clearer answers about the safety and impact of therapies and pregnancy-related factors on MS and related neurological conditions over time.

Multiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system and is a leading cause of severe disability in young people. This trial studies patients with active MS who have already been treated with ocrelizumab for 2 years and aims to compare the effects of spacing ocrelizumab infusions every 12 months versus the standard 6-month schedule. The goal is to see if the annual infusion schedule can maintain control of the disease without increasing activity, potentially reducing infection risk and treatment costs. Participants receive ocrelizumab infusions either every 6 months or every 12 months after having completed at least four semi-annual cycles of treatment. The study evaluates the non-inferiority of the 12-month interval compared to the 6-month interval. The two treatment groups help assess whether extending the time between infusions affects disease control in patients with active MS. Throughout the study, participants undergo follow-up MRI scans to monitor disease activity, and clinical evaluations to check for relapses and disability status using EDSS scores. The main outcome measured is the absence of radiological disease activity after 2 years. Participants also provide informed consent and must have proficiency in French and social insurance coverage. Safety and efficacy are monitored over the course of the study to understand the impact of infusion spacing on disease control and infection risks.

This research focuses on patients who experienced an acute ischemic stroke and were treated with clot-dissolving medicine and a procedure to remove the blood clot. Despite these treatments, about half of the patients do not fully recover. The study aims to evaluate whether specific brain imaging scores, alone or combined, can better predict patients' recovery and successful reopening of blood vessels 90 days after the stroke. The study will enroll 152 patients over approximately 9 months to find reliable tools that doctors can use to improve treatment decisions. Participants in this study will have had both thrombolysis (clot-busting medicine) and thrombectomy (clot removal procedure). The study does not involve additional treatments or interventions but focuses on analyzing brain imaging scores and clinical data collected during and after treatment. There is no separate extension or long-term treatment phase beyond the 90-day follow-up. During the study, patients will be followed up clinically at 90 days to assess their functional outcome using the modified Rankin Scale (mRS), which measures recovery and disability. Researchers will analyze brain imaging data taken at the time of stroke treatment to understand how imaging scores relate to recovery and vessel reopening. The main outcome measured is a favorable functional status, defined as an mRS score between 0 and 2 at 90 days. This helps determine the usefulness of imaging scores as predictive tools after stroke treatment.

Colorectal cancer mainly affects elderly patients, with over half of new cases in France occurring in those aged 70 or older. Adjuvant chemotherapy has shown benefits in disease-free and overall survival after stage III colon cancer surgery, but its use in elderly patients remains limited. This phase III randomized study explores whether adjuvant chemotherapy improves disease-free survival in elderly patients and which chemotherapy regimen is most effective, addressing concerns about benefits for both unfit and fit elderly patients. Participants will be divided into two groups based on a multidisciplinary evaluation including a geriatrician. One group will receive fluoropyrimidine-based chemotherapy (LV5FU2 or capecitabine), and the other will receive oxaliplatin-based chemotherapy (FOLFOX4 or XELOX). Some patients may be assigned to observation only. Treatments will begin within 12 weeks after surgery. The study also evaluates specific biological markers common in elderly tumors, such as mismatch repair deficiency. During the study, participants will undergo assessments including geriatric questionnaires and medical monitoring. Researchers will track disease-free survival over three years following the last patient's enrollment. Safety and treatment effects will be monitored, with exclusion of patients expected to live less than four years or those unable to comply with follow-up. The study aims to better understand chemotherapy benefits in an elderly population after colon cancer surgery.

Researchers are evaluating treatments for patients with relapsing-remitting multiple sclerosis (RRMS), an autoimmune disease affecting the central nervous system. This trial compares two medications, rituximab and ocrelizumab, to see if rituximab is not less effective than ocrelizumab in keeping active RRMS patients free from disease activity over two years. Both drugs target B cells, which play a role in MS, and rituximab has been used off-label with promising safety and effectiveness, while ocrelizumab is a newer, approved treatment. The study addresses the high cost difference between these therapies and aims to confirm if rituximab could be a more economical option. Participants receive either rituximab or ocrelizumab through infusion treatments following a typical schedule: at treatment start, after 15 days, and then every six months for two years. Two groups are compared to assess the percentage of patients without disease activity after this period. The study includes six follow-up visits aligned with treatment infusions, during which health and quality of life questionnaires are also completed. During the study, participants undergo brain MRI scans within six months before joining and regular assessments at each visit to monitor disease status, safety, and treatment effects. Researchers track the occurrence of relapses and new brain lesions to measure disease activity. Participants provide informed consent, and their health insurance coverage is confirmed. The total duration of participation is two years, with regular clinical and radiological evaluations to ensure safety and gather data on the treatments' effectiveness.