A Phase II/III, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM) for Induction and Maintenance Therapy in Patients With Mild to Moderately Active Ulcerative Colitis

Double-blind, randomised, placebo-controlled phase II / III trial evaluating efficacy and safety of two different doses (2 g/d or 3 g/d) of oral controlled-ileocolonic-release nicotinamide (CICR-NAM) compared to placebo in patients with ulcerative colitis (UC).
The intended therapeutic use of CICR-NAM is to improve intestinal inflammation in adults with UC by topically increasing nicotinamide supply in the ileocolonic region and thus favourably influencing the composition of intestinal microbiota

Start Date21 Aug 2024

Sponsor / Collaborator

Universitätsklinikum Schleswig-Holstein

[+3]

NCT06567977 / RecruitingNot Applicable

TriMaximize: A Multicentre, Prospective, Non-interventional Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extra-fine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes.

TriMaximize: A multicentre, prospective, non-interventional trial monitoring therapy pathways of asthma patients treated with an extra-fine ICS/LABA/LAMA single-inhaler triple therapy in a real-world setting and characterizing the effects on health-related outcomes.

Start Date01 Aug 2024

Sponsor / Collaborator

GKM Gesellschaft für Therapieforschung mbH

NCT06100042 / RecruitingNot Applicable

Multicentre, Prospective, Non-interventional Study Monitoring Therapy Pathways of Asthma Patients Treated With an Extrafine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes

TriMaximize is a non-interventional study aimed to collect prospective data from asthmatic patients under routine care, for whom their treating physician has decided to prescribe BDP/FF/G (beclomethasone/formoterol/glycopyrronium).

Start Date24 Apr 2024

Sponsor / Collaborator

Chiesi Ltd.

[+1]

100 Clinical Results associated with GKM Gesellschaft für Therapieforschung mbH

0 Patents (Medical) associated with GKM Gesellschaft für Therapieforschung mbH

Literatures (Medical) associated with GKM Gesellschaft für Therapieforschung mbH

01 Mar 2024·64. Kongress der Deutschen Gesellschaft für Pneumologie und Beatmungsmedizin e. V.

Real-World-Daten zur Wirksamkeit der einmal täglichen Dreifachfixkombination aus Fluticasonfuroat/Umeclidinium/Vilanterol bei der Therapie der symptomatischen COPD: Die ELLITHE nichtinterventionelle Studie

Author: Schmutzler, H ; Beeh, K ; Scheithe, K ; Krüger, S

01 Feb 2024·ACR Open Rheumatology

Radiographic Progression in Sacroiliac Joints in Patients With Axial Spondyloarthritis: Results From a Five‐Year International Observational Study

Article

Author: Sieper, Joachim ; Akar, Servet ; Altmaier, Elisabeth ; Protopopov, Mikhail ; Haibel, Hildrun ; Diekhoff, Torsten ; Muñoz-Fernández, Santiago ; Inman, Robert D ; Ganz, Fabiana ; Poddubnyy, Denis

ObjectiveTo evaluate progression from nonradiographic (nr‐) to radiographic axial spondyloarthritis (r‐axSpA) over 5 years in patients with recently diagnosed (≤1 year) axSpA fulfilling the Assessment of SpondyloArthritis international Society (ASAS) classification criteria.MethodsA prospsective, observational study (Patients with Axial Spondyloarthritis: Multi‐Country Registry of Clinical Characteristics) was conducted in rheumatology practices in 29 countries. Baseline and follow‐up radiographs of sacroiliac joints were centrally evaluated by three readers according to the grading system of the modified New York criteria for patients initially classified as nr‐axSpA. Radiographic progression from nr‐axSpA to r‐axSpA was evaluated by Kaplan‐Meier analysis. Cox proportional regression analyses for progression from nr‐axSpA to r‐axSpA were also conducted.ResultsAmong 2,165 patients with axSpA, 1,612 (74%) were classified as having r‐axSpA (1,050 [65%]) or nr‐axSpA (562 [35%]) by central reading. Of 246 patients with nr‐axSpA (mean [SD] symptom duration: 4.4 [6.2] years) who had at least one follow‐up sacroiliac joint radiograph, progression from nr‐axSpA to r‐axSpA at any follow‐up visit was observed in 40 patients (16%) over 5 years. Mean time to radiographic progression was 2.4 years (ranging from 0.9 to 5.1 years). Progression to r‐axSpA was associated with male sex (hazard ratio [HR] 3.16 [95% CI 1.22–8.17]), fulfillment of the imaging arm of the ASAS classification criteria (HR 6.64 [1.37–32.25]), and good response to nonsteroidal anti‐inflammatory drugs (HR 4.66 [1.23–17.71]).Conclusion16% of patients with nr‐axSpA progressed to r‐axSpA within 5 years. Male sex, fulfillment of the imaging arm of the ASAS criteria, and good response to nonsteroidal anti‐inflammatory drugs were predictors of radiographic progression in patients with recently diagnosed axSpA.

01 Jan 2023·International Journal of Cardiology

Association between sacubitril/valsartan initiation and changes in left ventricular ejection fraction: Insights from ARIADNE registry

Article

Author: Drożdż, Jaroslaw ; Zeymer, Uwe ; Koch, Cornelia ; Kalus, Stefanie ; Ferber, Philippe C ; Clark, Andrew L ; Barrios, Vivencio ; Fonseca, Candida ; Lund, Lars H ; Maggioni, Aldo P ; Damy, Thibaud

AIMSWe tested the hypothesis that initiation versus non-initiation of sacubitril/valsartan is associated with a more favorable subsequent change in left ventricular ejection fraction (LVEF) in a real-world setting.METHODSA prospective, non-randomized, double-arm, open-label, cohort study had been conducted across 687 centers in 17 European countries enrolling HFrEF patients aged ≥18 years with symptoms of HF (New York Heart Association [NYHA] II-IV) and "reduced LVEF". For the current analysis, 2602 patients with LVEF measured at baseline and follow-up were chosen, of which 860 (33%, mean age 67 years, 26% women) were started on sacubitril/valsartan at baseline and 1742 (67%, 68 years, 23% women) were not. Patients started on sacubitril/valsartan had higher NYHA class and lower LVEF.RESULTSLVEF increased from mean 32.7% to 38.1% in the sacubitril/valsartan group versus from 35.9% to 38.7% in the non-sacubitril/valsartan group (mean difference in increase 2.6%, p < 0.001). LVEF increased from baseline in 64% versus 53% of patients and increased by ≥5% (absolute %) in 50% versus 35% of patients in the sacubitril/valsartan versus non-sacubitril/valsartan groups, respectively. In the overall cohort, initiation of sacubitril/valsartan was independently associated with any increase in LVEF (adjusted odds ratio [OR] 1.49 [1.26-1.75]) and with increase by ≥5% (OR 1.65 [1.39-1.95]).CONCLUSIONInitiating versus not initiating sacubitril/valsartan was independently associated with a greater subsequent increase in LVEF in this real-world setting. Reverse cardiac remodeling may be one mechanism of benefit of sacubitril/valsartan.

100 Deals associated with GKM Gesellschaft für Therapieforschung mbH

100 Translational Medicine associated with GKM Gesellschaft für Therapieforschung mbH

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