Andernach

Researchers are studying the effects of etrasimod as a treatment for adults with moderate to severe ulcerative colitis. The study aims to understand how etrasimod works in real-world medical practice for patients aged 18 to 64 who have not taken this medication before. Patients will be treated according to standard medical care, with etrasimod chosen as the best treatment option by their physician. All participants will receive etrasimod as prescribed in routine care. The study lasts for 52 weeks, followed by a 28-day safety follow-up. During this time, patients will visit their doctors as usual and complete health questionnaires on their own mobile phone, tablet, or computer at regular intervals. These questionnaires will help track their health and treatment effects. Participants will be assessed by comparing their disease activity before starting etrasimod to their progress during treatment. Data collected includes patient-reported outcomes via online questionnaires and clinical assessments done during regular doctor visits. The main outcomes measured are the proportion of patients who achieve symptom remission at 12 weeks and 52 weeks.

Researchers are conducting a prospective, non-interventional observational study to evaluate the long-term effects of dupilumab treatment in patients aged 6 years and older with atopic dermatitis (AD). The study aims to understand the characteristics of AD patients in Germany who receive dupilumab under everyday conditions, including their medical history, socio-demographic and disease-related features, associated atopic comorbidities and type 2 inflammation diseases, as well as their previous and ongoing AD treatments. The study will also assess therapeutic response rates at Month 6 and long-term efficacy at Months 12 and 24 by measuring disease control with tools such as the Atopic Dermatitis Control Tool (ADCT) and Recap of Atopic Eczema (RECAP). Additionally, the study will observe dosing patterns, reasons for treatment changes, and collect long-term safety data. Participants will receive dupilumab treatment as part of their routine care without any intervention from the study. The observation period for each participant lasts up to 2 years or until dupilumab treatment is discontinued. Visits will be scheduled according to the standard of care, and the study will collect data on variations in dosing regimens, treatment initiation or discontinuation reasons, and concomitant therapies. During the study, participants or their guardians will complete questionnaires to assess signs, symptoms, quality of life, and disease control related to atopic dermatitis. Researchers will monitor outcomes such as the number of patients maintaining controlled disease states between Months 6 and 12, and changes in ADCT and RECAP scores over 52 weeks. Safety data will also be collected throughout the observation period to evaluate the long-term effects of dupilumab in both adult and pediatric patients.

Researchers are evaluating the safety and effectiveness of mesenchymal stem cells (MSC) derived from umbilical cord tissue (UC-MSC) for treating cartilage damage in the knee joint. This Phase I/IIa clinical trial is a multicenter, single-arm, open-label study involving patients aged 18 to 60 years with symptomatic cartilage defects. The study aims to monitor safety and collect initial data on the treatment's effects over a two-year period after surgery. Eligible patients will receive knee surgery on Day 0, during which the investigational product—10 to 20 million UC-MSC suspended in 1 ml and applied to a collagen carrier (Chondro-Gide®)—will be applied once directly to the cartilage defect. Follow-up visits are scheduled at regular intervals throughout the following 24 months to observe safety and gather efficacy data. Participants will undergo screening to confirm eligibility before treatment. During the study, they will be monitored through clinical assessments and data collection related to any serious adverse events within 24 months after surgery. The study focuses on safety outcomes primarily but also gathers information on treatment effects on the cartilage damage. The total participation duration for each patient is approximately two years post-surgery.

Ulcerative colitis (UC) is an inflammatory bowel disease causing inflammation and bleeding in the colon and rectum. This research aims to assess how treatment with risankizumab affects disease activity in adults with moderate to severe UC in real-world clinical settings. Risankizumab is an approved medication for UC, and the study will enroll about 200 adult participants across multiple sites in Germany and Austria. Participants will receive risankizumab as prescribed by their own doctors following routine clinical practice and according to local guidelines. There are no additional treatments or interventions beyond normal care. The study will follow participants for up to 52 weeks to observe changes in their disease activity while on this medication. During the study, participants will attend regular visits at hospitals or clinics as usual for their condition. Researchers will monitor the percentage of participants achieving symptomatic remission based on a standard scoring system over approximately one year. No extra burden beyond routine clinical visits is expected for participants throughout the study.