Altenholz

Researchers are evaluating various approved injectable and oral disease-modifying treatments (DMTs) in patients with relapsing multiple sclerosis (RMS) in Germany. This observational, non-interventional, multicenter, open-label study collects primary data prospectively over up to four years, alongside retrospective data. The study captures medical history, disease duration, laboratory values, disability scores (EDSS), MRI results, and relapse information to provide real-world insights into treatment use and outcomes. Patients receiving routine medical treatment with any approved injectable or selected oral DMTs—including ofatumumab, glatiramer acetate, interferon 21, teriflunomide, dimethyl fumarate, and diroximel fumarate—are enrolled without treatment allocation by the study. Two cohorts are observed: one treated primarily with injectable DMTs and another with injectable or oral DMTs. The core study period lasts about two years, with an optional extension providing an additional two years of observation, totaling up to four years. Follow-up visits and monitoring happen at the investigator's discretion and may include telemedicine. During the study, participants provide data through questionnaires and electronic case report forms. Routine clinical care procedures, such as diagnostic tests and monitoring, continue as usual. Researchers measure the proportion of patients continuing their baseline treatment at 24 months and collect ongoing clinical and imaging data. The study emphasizes real-world treatment patterns, safety, and disease activity over the extended follow-up period.

Researchers are evaluating the clinical utility of serum neurofilament light (sNfL) as a prognostic marker for disease activity in patients with relapsing multiple sclerosis (MS). This prospective, multicenter, observational, non-interventional study in Germany aims to understand how sNfL values can influence patient management and treatment decisions. The study focuses on patients treated with category 1 disease-modifying therapies (DMTs) who have incorporated sNfL testing into their care. Participants will either continue their current category 1 DMT, which includes therapies such as dimethylfumarate, glatiramer acetate, interferon beta, and teriflunomide, or switch to ofatumumab based on their physician’s clinical judgment. There is no treatment allocation by the study itself. Data collection will cover up to 24 months, and the frequency of visits and assessments will follow routine clinical practice without a fixed protocol. During the study, baseline and follow-up data will be gathered according to standard care recommendations, including clinical evaluations and sNfL measurements. Researchers will monitor the proportion of patients with high sNfL levels over time to assess disease activity. The observational period is flexible and guided by the treating physician, with no additional diagnostic or monitoring procedures beyond standard care. Participants will be followed for up to two years to better understand how sNfL influences treatment management in relapsing MS.

Ulcerative colitis (UC) is an inflammatory bowel disease causing inflammation and bleeding in the rectum and colon. This research evaluates the effectiveness of upadacitinib (RINVOQ), an approved treatment for UC, in adults with active moderate to severe UC. The study aims to understand the early therapeutic response and predict the long-term effectiveness of this medication. Upadacitinib will be given according to the approved local label and prescribed by the participant's physician as part of routine care. About 400 adult participants from Germany, Austria, and Switzerland who are starting upadacitinib treatment will be enrolled. Treatment decisions are made by the investigator independently of the study. Participants will be followed for up to two years, with no extra procedures beyond their standard care. During the study, participants will attend regular hospital or clinic visits where routine data will be collected and used for the study. Researchers will monitor the percentage of participants achieving symptomatic remission based on clinical response and intestinal ultrasound at week 8, with follow-up assessments at week 52. The study focuses on real-world treatment outcomes without adding extra burden to participants.

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.