Dunkerque

Researchers are evaluating the efficacy and safety of Synolis VA 80/160 in treating symptoms of hip osteoarthritis over a period of 6 months. This multicenter, independent study focuses on adults with hip osteoarthritis confirmed by specific clinical and radiographic criteria. The study aims to assess patient outcomes using measures like the Oxford Hip Score to track improvements in hip pain and function. Participants will receive Synolis VA 80/160, a device containing hyaluronic acid 80 mg and sorbitol 160 mg, designed to be injected into the hip joint. The study includes patients who have experienced inadequate relief from standard pain treatments and have not had prior injections in the target hip within the last 6 months. The treatment and follow-up periods extend over 6 months to monitor effects and safety. Throughout the study, participants will be monitored for changes in hip pain and function using the Oxford Hip Score at 6 months. Assessments include clinical evaluations, radiographic imaging, and safety observations. Participants’ adherence and responses will be tracked to evaluate the treatment's impact on hip osteoarthritis symptoms and overall patient well-being during the study period.

Researchers are evaluating whether adding zilovertamab vedotin to standard treatment helps people with previously untreated diffuse large B-cell lymphoma (DLBCL) live longer without their cancer growing or spreading. This Phase 3 study compares zilovertamab vedotin combined with rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) against the standard regimen of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). The goal is to see if the new combination improves progression-free survival. Participants receive treatments through intravenous infusions of study drugs including zilovertamab vedotin, rituximab or its biosimilar, cyclophosphamide, doxorubicin, and vincristine, along with oral prednisone or prednisolone as per approved guidelines. Some may receive rescue medication such as granulocyte colony-stimulating factor (G-CSF) if needed. The study is open-label and conducted across multiple centers. During the study, participants are closely monitored for how long they live without their disease worsening, with follow-up up to approximately 50 months. Assessments include imaging scans like PET to evaluate disease status, heart function tests, and regular evaluations of overall health and side effects. Safety is monitored throughout, and researchers measure progression-free survival as the primary outcome to determine the effectiveness of the treatments.

Researchers are evaluating a personalized maintenance therapy for pemphigus, a life-threatening chronic autoimmune blistering disease affecting the skin and mucous membranes. This study focuses on comparing this personalized approach, which uses anti-desmoglein antibody levels as biomarkers, with the standard treatment involving rituximab combined with corticosteroids. The trial builds upon previous successful studies that supported rituximab's approval for pemphigus treatment by the FDA and EMA. Patients in the personalized maintenance group receive additional rituximab infusions based on their antibody levels and disease activity, aiming to prevent relapses and reduce the need for corticosteroids. The standard treatment consists of two doses of rituximab combined with oral corticosteroids, given after a clinical relapse. The study monitors antibody levels and disease activity over time to guide treatment decisions. Participants will undergo regular assessments, including clinical evaluations and antibody measurements, over a 7.5-year period to track the number of disease relapses per patient-year. The study also involves monitoring safety, treatment adherence, and the effectiveness of the personalized treatment strategy compared to the standard approach. Participation includes vaccination requirements and compliance with study protocols to ensure safety and reliable results.

Researchers are evaluating whether adding local consolidative radiotherapy to the standard treatment can improve overall survival in patients with metastatic urothelial bladder cancer. The study focuses on patients who have no disease progression and have no more than three remaining distant metastatic lesions after completing first-line systemic therapy. This is a Phase II, multicenter, randomized, open-label trial with a follow-up period of 4 years for each participant. Participants are assigned to receive either standard care alone or standard care combined with consolidative radiotherapy targeting the pelvic area and/or metastatic lesions. Radiotherapy may be combined with previous transurethral resection of bladder tumor as part of the treatment. The study includes patients who have completed 4-6 cycles of first-line systemic therapy, including chemotherapy and/or immunotherapy, and have no progression of disease. Patients who began maintenance therapy are also eligible. During the study, participants will be monitored over 4 years from randomization. Researchers will assess overall survival as the primary outcome. Participants will undergo imaging scans to evaluate metastatic lesions and may be assessed for eligibility for stereotactic body radiotherapy (SBRT) based on dose constraints and prior radiotherapy exposure. The study also involves regular follow-up to monitor disease status and treatment safety.

Researchers are evaluating whether using fungal biomarkers can help doctors stop antifungal treatment earlier in critically ill patients suspected of invasive Candida infections. The study aims to compare this biomarker-based approach to the usual care strategy, assessing if early discontinuation can safely reduce unnecessary antifungal use without increasing mortality by day 28. This is a randomized controlled open-label study involving patients who need empirical antifungal therapy for the first time in the ICU. Participants are divided into two groups. The intervention group will have their antifungal treatment duration guided by blood tests measuring (1,3)-Beta-D-glucan and mannan levels at the start of treatment and on day 3, with recommendations to stop treatment early if biomarker results allow. The control group will receive routine care based on international guidelines, typically involving 14 days of treatment if no proven infection occurs and the patient improves, or shorter durations in other cases. During the study, researchers will monitor when antifungal treatment is stopped, particularly noting if treatment ends before day 7 after it begins. They will also track patient outcomes up to day 28 to ensure safety. Participants must provide informed consent and are expected to stay in the ICU for at least 6 days after starting treatment. The main outcome measured is the percentage of patients who stop antifungal therapy early according to the study protocols.

Researchers are evaluating the effects of caffeine on cognitive decline in people with Alzheimer's disease at the beginning to moderate stages. This phase 3 trial aims to compare the impact of caffeine treatment versus placebo on cognition over 30 weeks. Alzheimer’s disease is a complex condition with no current cure, and caffeine's properties may offer symptomatic benefits, although high doses could cause anxiety and insomnia, especially in this vulnerable group. Participants will undergo a 6-week caffeine diet before starting treatment. Then, caffeine or placebo capsules will be given with a titration phase of 3 weeks increasing the dose by 100mg every stage until reaching a target of 400mg daily in two doses, maintained for 27 weeks. After treatment, doses will be gradually decreased following the same schedule. During the study, participants will be monitored for changes in cognitive function measured by neuropsychological tests at 30 weeks after randomization. Caregivers will be involved, and participants’ clinical status, safety, and adherence to a low caffeine diet will be assessed. The total participation duration includes the caffeine diet, titration, treatment, and dose reduction phases.

Researchers are conducting a phase 3, multicenter, open-label, randomized study to evaluate new treatments for adults with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation (ASCT). The study aims to compare the effectiveness and safety of a combination of elranatamab and lenalidomide as a replacement for standard chemotherapy during the consolidation phase, and to assess elranatamab alone versus standard care during maintenance therapy. Participants will first receive standard induction therapy with four cycles of a drug combination called D-VRd. After this, they will be randomly assigned to either receive standard consolidation therapy involving high-dose chemotherapy and ASCT followed by D-VRd consolidation (Arm A), or elranatamab combined with lenalidomide for consolidation (Arm B). Upon completing consolidation, patients will be re-randomized to receive maintenance treatment with either lenalidomide alone (Arm C) or elranatamab alone (Arm D). During the study, participants will be monitored for treatment effects including minimal residual disease negativity at the end of consolidation, progression-free survival, and overall survival. The study involves various assessments including clinical evaluations, laboratory tests, and monitoring for disease progression or side effects. The entire treatment and follow-up period may last up to several years, allowing researchers to evaluate long-term outcomes and safety.

Researchers are conducting a French prospective observational study to understand how patients aged 18 years and older with moderate to severe atopic dermatitis (AD) are managed when eligible for or currently receiving systemic therapy. The study aims to describe treatment patterns, including previous and current therapies, and monitor drug survival and compliance over time. Experienced dermatologists in hospital and office settings will participate, ensuring treatment decisions reflect real-world clinical practice. Patients will be followed for one year under routine care, with systemic treatment decisions made solely by their physicians independent of study enrollment. The study does not involve specific interventions or changes in treatment but observes the use and management of systemic therapies for AD, including topical corticosteroid use and other systemic options. Participants will complete questionnaires and undergo assessments at baseline, six months, and twelve months. Researchers will collect data on previous and current treatments, therapeutic management of atopic comorbidities, drug survival changes, and treatment adherence. The study focuses on gathering real-life information on systemic therapy use and patient outcomes over the 12-month follow-up period.

This research aims to analyze the use of Glofitamab in patients with relapsed or refractory Large B-cell Lymphoma (DLBCL) treated under the Expanded Access Programme (EAP) in France. The study focuses on evaluating the effectiveness and safety of Glofitamab in a real-world setting, including a subgroup of patients previously treated with chimeric antigen receptor T-cell therapy (CAR-T). The goal is to confirm reported response rates and to determine the best timing for starting Glofitamab treatment. Participants in this study received Glofitamab as a treatment for DLBCL, with prior pretreatment using Obinutuzumab. The study involves retrospective analysis of patients who enrolled in the French Glofitamab EAP before November 1, 2024, and who have received at least one infusion of Glofitamab. No additional interventions or treatment arms are described, as the study reviews data from real-world use. During the study, researchers will assess the best complete response rate (CRR) to Glofitamab treatment over a six-month period using the Lugano 2014 criteria. The analysis includes a median follow-up of more than nine months to monitor treatment outcomes and safety. Participants' data will be collected only if they have consented or did not oppose their data use for this study.

Researchers are evaluating a medicine called elranatamab for the treatment of multiple myeloma (MM), a type of cancer. This study focuses on people aged 18 or older who have MM that has returned or not responded to previous treatments, including prior use of an anti-CD38 antibody and lenalidomide. The goal is to compare elranatamab to other common combination therapies that include 2 to 3 different MM medicines. This is a Phase 3 study to learn about the safety and effectiveness of elranatamab compared to these other treatments. Participants will be randomly assigned to receive either elranatamab or a combination therapy selected by the study doctor. Elranatamab is given as a shot under the skin at the study clinic about once a week, which may later reduce in frequency. The combination therapy options include medicines taken by mouth and given either as shots under the skin or through a needle in the vein at the clinic. The combination medicines used may be elotuzumab, pomalidomide, dexamethasone, bortezomib, or carfilzomib, depending on the chosen treatment plan. Participants may continue their assigned treatment until their MM stops responding. During the study, participants will visit the clinic regularly for monitoring and evaluation. Researchers will track how well the treatments work by measuring progression-free survival and will watch for any side effects or safety concerns. Follow-up will continue after treatment ends through phone calls or visits. The study may last up to about 5 years to fully assess the outcomes of the treatments.