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Found 2 Actively Recruiting clinical trials
Actively Recruiting
This observational study follows patients with relapsing multiple sclerosis RMS who are being treated with approved injectable or selected oral disease-modifying therapies DMTs in Germany. The study is non-interventional and open-label, designed to collect real-world data on treatment and disease progression over several years. It aims to understand how patients continue their baseline treatments and how these treatments impact various health and quality of life measures. Participants receive routine medical care with approved injectable or oral DMTs such as ofatumumab, interferon b21, glatiramer acetate, teriflunomide, dimethyl fumarate, or diroximel fumarate. The study includes two cohorts with up to approximately two years of prospective observation each, with an optional extension allowing up to four years total. Treatment decisions and monitoring follow the patients usual care and physicians discretion, including routine visits and telemedicine options. During the study, participants provide medical history, complete questionnaires, and have data collected on disability status, MRI findings, relapses, and laboratory tests. Researchers assess treatment continuation rates, fatigue, anxiety, depression, quality of life, lesion counts, and relapse rates at multiple time points. Safety and treatment interruptions are also documented. Follow-up is flexible and based on standard care procedures, with data collection occurring throughout the observational periods.
Actively Recruiting
Real-World Evaluation of Risankizumab Treatment in Adults with Moderate to Severe Ulcerative Colitis
Ulcerative colitis UC is a chronic inflammatory bowel disease causing inflammation and bleeding in the rectum and large intestine. This research aims to assess changes in disease activity in adults with moderate to severe UC who are treated with risankizumab in real-world clinical practice. The study will observe approximately 200 adult participants prescribed risankizumab by their physicians in Germany and Austria. Participants will receive risankizumab as prescribed by their doctors according to the approved local label and routine clinical care. The study does not introduce additional treatments or procedures beyond what is normally provided. Participants will be followed for up to 52 weeks while continuing their usual medication schedule. Throughout the study, participants will attend regular hospital or clinic visits as part of their routine care. Researchers will track the percentage of participants achieving symptomatic remission using the Partial Adapted Mayo Score over about 52 weeks. There is no expected added burden, and participants will receive standard monitoring and care during this period.